Podcasts about gmps

Christian Ararat, M.Sc., M.Eng. is a food safety professional with more than ten years of experience in food safety and quality. After earning a bachelor's degree in Food Science from Valley University in Colombia, he began his career in the bakery industry, where he implemented and enforced good manufacturing practices (GMPs) and prerequisite programs. After moving to Canada, Christian joined Natursource Inc., a Montreal-based food manufacturing company dedicated to producing healthy snacks. As head of the Quality Assurance department, Christian implemented the Global Food Safety Initiative (GFSI) SQF food safety system; helped the company to achieve claims such as gluten-free, non-GMO, and Halal; and maintained certifications such as Organic and Kosher. Christian has continued his education and pursued a master's degree in Food Safety and a master's degree in Quality Systems Engineering. Currently, he serves as the Director of Quality and Laboratory at Geloso Beverage Group, the first wine manufacturer in Québec, Canada. In this episode of Food Safety Matters, we speak with Christian [46:53] about: How variances in audit scores can cause issues for food safety professionals Things food and beverage companies should be paying close attention to on their audit results The importance of striving for continuous improvement over a specific audit score, and how this informs food safety culture How traceability is measured on audits and why food and beverage companies should still prioritize traceability, despite the recent 30-month extension of the U.S. Food and Drug Administration's (FDA's) Food Traceability Final Rule/FSMA 204 compliance date A $26-million budget cut coming to the Canadian Food Inspection Agency (CFIA) in 2026, and how it could affect CFIA's surveillance and enforcement work The differences between certified “Organic” criteria required by the U.S. Department of Agriculture (USDA) versus FDA's Foreign Supplier Verification program (FSVP), and how those differences affect organic food and beverage exporters to the U.S. Limitations imposed by FDA's evaluation protocols for FSVP-registered entities Potential applications of artificial intelligence (AI) that could bolster food safety efforts, as well as possible pitfalls that should be considered when looking to leverage AI for food safety. In this episode, we also interview Joseph Corby [24.26], the recipient of Food Safety Magazine's 2025 Distinguished Service Award, about his career in food safety and his advocacy for a nationally integrated food safety system. After receiving a degree in Environmental Health, Joseph Corby worked for the New York State Department of Agriculture and Markets for 38 years, beginning as a Food Inspector in 1970 and retiring in 2008 as the Director of the Division of Food Safety and Inspection. He then went on to become the Executive Director of the Association of Food and Drug Officials (AFDO), a role he held for ten years, and is now a Senior Advisor for AFDO. Joseph has served as an Instructor for the U.S. Food and Drug Administration (FDA), AFDO, the International Food Protection Training Institute (IFPTI), Louisiana State University, the National Environmental Health Association (NEHA), the University of Tennessee, and Oregon State University. He continues to be an outspoken advocate for the advancement of a nationally integrated food safety system and works with numerous groups and associations in support of this cause. News and Resources News USDA Withdraws Proposed Regulatory Framework for Salmonella in Poultry After Years of Development FDA Announces Plan to Phase Out Synthetic, Petroleum-Based Food Dyes From U.S. Food Supply Rumored FDA Budget Proposal Would Cut Funding, Move Routine Food Inspections to States FDA Reportedly Reinstating Some Fired Food Safety Scientists, Inspection Support Staff FDA Testing Finds Bottled Water Samples Do Not Exceed EPA Limits for PFAS in Drinking WaterResearchers Develop Nanocage-Based Filter That Removes 90 Percent of PFAS From Groundwater Resources “Is AI 'Food Safe?'” by Christian Ararat, M.Sc., M.Eng. for Food Safety MagazineJoseph Corby to be Honored with Food Safety Magazine's 2025 Distinguished Service Award Sponsored by: Hygiena We Want to Hear from You! Please send us your questions and suggestions to podcast@food-safety.com

Kathy Knutson, Ph.D., PCQI, is the Founder of Kathy Knutson Food Safety Consulting LLC, an author, and the Chair of the Education Committee for the National Cannabis Industry Association (NCIA), with expertise in the fields of bacteriology, food science, and education. She speaks, writes, and trains on U.S. Food and Drug Administration Food Safety Modernization Act (FDA FSMA) compliance, and has also trained over 500 Preventive Controls Qualified Individuals (PCQIs) throughout her career. Dr. Knutson works with managers to help them write thorough hazard analyses, food safety plans, recall plans, environmental monitoring programs, and allergen programs. Additionally, Dr. Knutson travels to manufacturers to conduct swabbing to locate pathogens during recall investigations, as well as for gap assessments of Good Manufacturing Practices (GMPs) for cannabis-infused edibles. In 2020, she published her book, titled, Food Safety Lessons for Cannabis-Infused Edibles.   In this episode of Food Safety Matters, we speak with Dr. Knutson [48:30] about: How she became interested in food safety for cannabis-infused edibles and beverages, and the challenges she faced in transitioning to the cannabis industry Her work with NCIA, as well as with the ASTM International D37 Cannabis committee, where she is helping write the first GMP international standard for the cannabis industry The need for proper packaging and labeling to ensure the safety of cannabis-infused products, particularly in preventing underage use, as well as the importance of designing the products themselves to be unattractive to children How the patchwork of state regulations for cannabis complicates trade and testing, and the potential for future federal regulation of cannabis edibles as either foods or supplements The importance of implementing GMPs, HACCP plans, and preventive controls when producing cannabis-infused goods to prepare for potential federal regulation The need for training and recruitment of experienced individuals in the cannabis industry and the benefits of having dedicated quality assurance managers, as well as the advantages of having multiple Preventive Controls Qualified Individuals (PCQIs) in a food company or facility. Before our interview with Dr. Knutson, we also hear from Hal King, Ph.D. [3:42], the Editor of Food Safety Leadership in the Business of Food Safety, which is a new digital book published by Food Safety Magazine that serves as a resource for the retail foodservice industry. The book defines and models food safety business leadership from the perspective of top food safety business leaders at best-in-class retail foodservice operations. News and Resources News Stories and Related Items New Stakeholder Coalition Formed to Advocate for Effective FDA Human Foods Program [18:52] FDA Deputy Commissioner Jones Discusses Future of Human Foods Program Under His Leadership [20:41] FDA Proposes to Stop Allowing Brominated Vegetable Oil in Food, Says Red Dye 3 May Be Next “Food Safety Culture Collaboration: Are Regulators Adapting and Catching Up?” by Lone Jespersen, Ph.D., Rounaq Nayak, Ph.D., and Anne-Mette Olsen D.V.M., M.V.P.H. for Food Safety Magazine October/November 2023 California Passes Law Requiring Tests for Toxic Heavy Metals in Baby Foods, Disclosure of Results [34:02] FAO/WHO Establishes Recommended Threshold Values for Allergens in Foods [37:12] FAO/WHO Expert Committee Conducts Review of Foodborne Viruses to Support Codex Guidance Updates [38:56] FDA Publishes Results of FY 2021 Pesticide Residue Sampling Program for Foods [43:44] NACMCF's Report to FDA on Cyclospora in Produce Mentions Two Proposed Species that are Parasitic to Humans [44:28] “Outbreak Investigations of Cyclospora cayetanensis Infections 2013–2020: Progress Made and Challenges Remaining” by Stelios Viazis Ph.D., Fazila Shakir M.H.S., Anne Straily D.V.M., Adrienne Goodrich-Doctor Ph.D., Jeffery L. Sumter Dr.P.H., and Socrates Trujillo Ph.D. for Food Safety Magazine April/May 2022 Interview-Related Items “Packaging and Labeling Requirements for Cannabis-Infused Edibles” by Kathy Knutson, Ph.D., PCQI for Food Safety Magazine August/September 2023 The New Digital Book Edited by Hal King, Ph.D. and Published by Food Safety Magazine Food Safety Leadership in the Business of Food Safety (FREE download) Food Safety Magazine Webinars Beat the Recall: Effective Allergen Control in Food Manufacturing (Available for on-demand replay) Safely Serving All: Allergen Control and Response in Retail Foodservice (Live on December 12, 2023) We Want to Hear from You! Please send us your questions and suggestions to podcast@food-safety.com

In today's episode of Grow Sessions, we  explore the world of cannabis and its evolving standards. Joining us is our guest David Vaillancourt, a renowned expert from The GMP Collective. Good Manufacturing Practices, commonly referred to as GMPs, play a crucial role in ensuring that products are consistently produced and controlled according to strict quality standards. These practices are not exclusive to the cannabis industry; they are essential across all sectors. Just like any product you find on the shelves of your local grocery store, cannabis products must adhere to specific GMPs to guarantee their safety and quality.Intriguingly, the cannabis industry is still relatively young and rapidly expanding. As a result, there is ample room for improvement in ensuring the highest standards of product safety. In our latest episode, titled "GMP Standards and the Global Cannabis Market," we delve deep into this topic, shedding light on the importance of GMPs and their impact on the industry. Together we explore the current state of GMP standardization and discuss the potential for advancements in ensuring the highest level of product safety in the cannabis industry.Join us as we embark on this important journey of understanding and enlightenment and unravel the complexities and possibilities within the realm of GMPs and their role in shaping the cannabis industry.About David Vaillencourt, GMP CollectiveDavid Vaillencourt, holds a Master's of Science and is the CEO of The GMP Collective and Founder of the S3 Collective, is one of the most respected and effective change leaders in the cannabis industry. Combining his passion for a data driven approach with safety and quality, his group focuses on establishing and enabling the utilization of scientifically sound industry standards, encompassing Good Manufacturing Practices, risk mitigation strategies, and comprehensive supply chain solutions Since 2017, he has been an active member of ASTM International's Committee D37 on Cannabis, now serving as the elected Vice Chair. In this role, he empowers over 700 fellow volunteers spanning six continents to leverage the accredited open and transparent process that brings government, academia, industry, consumers, and other relevant stakeholders to develop consensus product safety standards based on science and data. As a public speaker, educator and connector, David emphasizes the importance of unbiased consensus standards in fostering a reliable and safe marketplace.David's most important initiative to date is the launch of the S3 Collective. This exclusive, agnostic nonprofit foundation is the first of its kind and will effectively connect all standards and best practices to policy and regulation to build an international framework. When not working, you can look for David in the Colorado backcountry skiing and trail running with his dog, Humphrey.To learn more, please visit GMP Collective.Thanks for listening. Be sure to subscribe to our podcast to receive upcoming episodes.

In this episode of The Herbalist Hour, I'm joined by Steven Yeager.  Steven is the Director of Quality and Regulatory Affairs at Mountain Rose Herbs.  He is also a friend and one of my main herbal mentors.  He taught alongside Howie Brounstein at the Columbines School of Botanical Studies when I took their two year apprenticeship over a decade ago.  Steven also serves on the board of several non-profits including United Plant Savers, American Herbal Products Association (AHPA), and the Native Plant Society of Oregon. In this conversation we chat about Steven's herbal origin story, GMPs, favorite plants and lot more.  I hope you enjoy the chat as much as I did!  Let us know in the comments if you had any takeaways.  Thanks to Steven for sharing his time and expertise, and thanks to you for watching! Seeya in the next episode, ~Mason LINKS & RESOURCES WATCH THE VIDEO FOR THIS INTERVIEW Learn more about Mountain Rose Herbs | MountainRoseHerbs.com Columbines School of Botanical Studies | BotanicalStudies.net AHPA | AHPA.org |  United Plant Savers | UnitedPlantSavers.org Cookbooks recommended by Steven | Yotam Ottolenghi

If you are in the consumer healthcare industry, you probably know about GMPs, or Good Manufacturing Practices. But what do they specifically mean when it comes to dietary supplements, and how do VMS companies prepare for an FDA inspection? More Information: CHPA Chat: The History of DSHEA and Its Founding Mothers and Fathers With special guests: Larisa Pavlick, Senior Director, Product Quality and Technical Affairs, CHPA, Josh Long, Associate Editorial Director, Natural Products Insider, Informa Markets Health and Nutrition, and Asa Waldstein, Principal, Supplement Advisory Group Hosted by: Anita Brikman, Senior Vice President, Communications & Public Affairs, CHPA; and Executive Director, CHPA Educational Foundation 

Our next guest's platform has been referred to as the Salesforce of Cannabis. It is active in over 25 markets and processes over $2.5 billion in annual sales. They have partnered with some of the largest multi-state cannabis operators and are responsible for over 35% of all cannabis wholesale orders nationwide and have more than 600 brands listed on the platform.Leaftrade helps facilitate ordering and fulfillment. It's more than a marketplace for wholesalers and retailers in the cannabis space. Leaf Trade streamlines the entire ordering & fulfillment process, payment process, and post-sale reporting. They go on to write about GMPs and How They Could Potentially Have a Financial Impact on the Cannabis Industry. Deciding to “Go GMP” could potentially have lasting financial impacts on cannabis businesses willing to do the work. They go on to write: More profit could also be made from higher prescription revenues when consumers are covered by state or private insurance providers.Advertising Inquiries: https://redcircle.com/brandsPrivacy & Opt-Out: https://redcircle.com/privacy

In the world of GMPs and quality, it's easy to overlook the importance of pest management until its too late. In this episode,  Frank Meek, Manager of Technical Services at Rollins/Orkin joins us to tell us how Orkin approaches all things pest control, from prevention, investigations, and control of pest along with other services they provide the industry. Frank Meek is a Technical Services Manager for Rollins. As a board-certified entomologist and 30-year industry veteran, he is an acknowledged leader in the field of pest management.  He loves insects, spiders, and crawl spaces. Listen in as Frank shares his passion for pest control and teaches Leslie and I how to be better insect detectives.To reach out to Orkin's industry team, visit here: https://www.orkincommercial.com/ You can also visit: https://www.orkin.com

In this episode, Rebecca Schaefer and Michael Hinckle review some types of hospital and health system activities that could trigger FDA regulatory oversight. They discuss the FDA's jurisdiction over IRB's in medical device clinical trials, sponsor obligations for investigator-initiated studies, and compliance for expanded access INDs and for GMPs in the case of hospital manufacturing of cell culture products and 3D printing.

Companies seeking to do business in the fast-growing food supplement market in the United States must ensure they're compliant with federal regs. Since the mid-1990s, the United States has been on the cutting edge of dietary and food supplement innovation, following the passage of legislation that carved out a regulatory category as a sub-set of food. Bolstered by consumer interest in preventive health, the industry has seen steady growth even in the face of questions about the level of FDA oversight of the supplement category. One of the fundamental pieces of supplement regulation is good manufacturing practices—GMPs—that are a requirement for bringing compliant products to market. In this podcast, Dr Tara Lin Couch, senior director for dietary supplements and tobacco services at EAS Consulting, shares insights around FDA's supplement GMPs, common misconceptions, and much more. Tune in to hear more about: Shifts in the US dietary supplement landscape in the last two years, and what the ‘new normal' looks like. Ways for overseas firms to stay abreast on the regulations impacting their business in the United States. The latest regulatory changes affecting food and dietary supplement production. How companies that market finished supplements can ensure their producers are compliant with GMPs. Guest: Tara Lin Couch, PhD, senior director for dietary supplements and tobacco services, https://www.easconsultinggroup.com (EAS Consulting Group) If you like the show, make sure to subscribe and follow the https://the-vitafoods-insights.captivate.fm/ (Vitafoods Insights podcast). Feel free also to recommend the show to a friend that you think would enjoy it. For more content from Vitafoods Insights, make sure to check our website:  https://www.vitafoodsinsights.com/ (https://www.vitafoodsinsights.com)     To learn more about sponsorships opportunities, https://informa.turtl.co/story/vitafoods-insights-2022-marketing-brochure/page/1 (click here) and make sure to check our media kit.

In this podcast episode, our guest is Troy Fugate, a pharma industry and GMP veteran with 30+ years of experience in the field. Now, he is the Vice President at Compliance Insight, Inc. They help businesses overseen by the FDA navigate the regulatory process, achieve compliance, and develop best practices for manufacturing innovative drugs, medical devices, and biologics. Troy believes that the single most challenging issue leaders face is incorporating GMPs into their company culture. The leaders don't know how to blend GMPs into their mission and vision with the right passion. Only then can employees see the whole vision and understand the "Why". Not just to do things because "it's required by the GMPs" but to see the value in those actions. Listening to the podcast or watching the clip, you will learn: How to establish a unified quality mission across a pharma organization Why some people see GxP as a hurdle, and how to change that Why using KPIs wrong can cost you your best employees How to Deliver Effective and Measurable GMP training ------------------------------------------------------------------------------------------------------ Watch or read the full podcast and read the article at https://podcast.qualistery.com/infusing-gxps-into-your-organizations-dna ------------------------------------------------------------------------------------------------------ This episode is Sponsored by Dot Compliance, the industry's first ready-to-use Quality Management Solution powered by the SalesForce platform. Implementation of a new eQMS has never been quicker nor easier. #Pharma #GMP #Pharmaceutical #Pharmaceuticalmanufacturing

The Fledge and the Impact of Covid 19 on community programming. Vicki talks with Jerry Norris is the CEO and Founder of the Fledge located in Lansing MI. Jerry obtained a B.S. in Statistics from the University of Michigan, with a focus on Computer Science. He began his career with the Unisys Corporation as a Quality Engineer and ISO 9000 Lead Auditor in 1988. Throughout the years, he moved up through the ranks of the quality profession (i.e. Quality Manager, Director of Quality, and VP of Quality). In 1988 as a Quality Engineer and Lead Auditor, he began developing a software product to help manage compliance activities. He served as the CEO of GAIA, LLC, which operated globally with customers in over 50 countries to help members connect based on expertise and vicinity. GAIA evolved into a software company supporting start-ups with an emphasis on mapping. Jerry now serves as the CEO of the Fledge, a radically inclusive ideation and maker space, incubator, and accelerator located in Lansing, MI. He also serves as the Chairman for the GAIA, Solutions, Power in Passion, and the Fledge Music Group. He also spent 5 years as a “Gatekeeper” for the Business Acceleration Fund working with the Lansing Economic Area Partnership. Jerry's expertise includes software development, quality management, food safety management, automotive and aerospace-related quality management, environmental protection and management, and safety systems. He also enjoys reading standards (e.g. ISO 17021, ISO 9001, GFSI) and following the industries that are moving from prescriptive systems (e.g. customer-based, GMPs) to more agile and adaptive management systems. Specialties: Quality Assurance, Statistics, Software Engineering, Sales, Food Safety, Compliance Management, Auditing, Inspections, International Business, Entrepreneurship, building Brands, start-up assistance, talent acquisition, funding. He has worked in the following fields: telecommunications, automotive, furniture, food safety, environmental management, economic development, human rights, labor law, life sciences, advanced manufacturing, plastics, consulting, organizational development, and more. Conversation summary: Vicki Hamilton-Allen chats with Executive Director, Jerry Norris about the increased need in the community during the COVID-19 pandemic and how the Fledge has become a center point in the community to provide much-needed opportunities to marginalized communities. Norris is an innovator and creative thinker, tune in and let him inspire you!

This week on the podcast, I'm speaking with Brian Bolen. Brian has 12 years of quality and CI experience. He's an ASQ, certified Six Sigma Black Belt. He also has his master's degree in operational excellence from Eastern Michigan University In this episode, Brian and I talk about why leaders need to be focusing on servant leadership and how it can help leaders be more effective in their roles. What You'll Learn This Episode: Servant leadership, what it is and why it matters Brian's experience with continuous improvement and how he got started How servant leadership helps leaders to lead more effectively Brian's biggest improvements and failures in his Lean career Brian's advice to someone just starting out in Lean Books and podcasts that have helped Brian through his Lean journey Why you should always be learning About the Guest: Brian Bolen is an Experienced Process Engineer with a demonstrated history of working in the consumer goods industry. Skilled in Continuous Improvement, Lean Six Sigma, Statistical Data Analysis, and GMPs. Brian is a strong engineering professional with a Master of Science (MS) focused in Quality Management and Operational Excellence from Eastern Michigan University. Important Links: https://www.linkedin.com/in/brianbolenlssbb/ --- Support this podcast: https://anchor.fm/leansolutions/support

In this episode Maria Rodia, Kirsty Macdonald and Claire Miller provide an update on GMP equalisation.      In particular, the group looks at:  Background to GMPs and the Lloyds judgments; Methodologies for GMP equality; Issues to consider when implementing GMP equality; and  Past transfers out.  To find out more about our Pensions team or this podcast, head to cms.law.    

Kodėl informacinių karų specialistas dr. Mantas Martišius parašė knygą apie ekonomiką „Kiek kainuoja laikas“?Ar atlikus COVID-19 testą mobiliajame punkte Lietuvoje, atsakymą būtų galima gauti anglų kalba? Tokios galimybės prašo keliaujantieji į užsienį. Sveikatos apsaugos ministerijos komentaras, Kauno miesto GMPS vadovas Nerijus Mikelionis, Valstybinės kalbos inspekcijos teisininkas Dainius Žemaitis, Lietuvos oro uostų atstovas spaudai Tadas Vasiliauskas.Portalo LRT.LT publikacijas jums jau gali perskaityti neuroninis balsas. Kokia tai technologija? LRT interneto departamento vadovas Ričardas Baltaduonis, Vytauto Didžiojo universiteto Informatikos fakulteto docentas Darius Amilevičius.Ved. Giedrė Čiužaitė

In episode number 20 of the Podcast "International Pharma Talks by ELS Solutions" our host, Dr.Diogo Sousa-Martis, Ph.D., MBA, will focus on “Good Manufacturing Practices and Quality Assurance ”. In this podcast, we will cover the topic of Good Manufacturing Practices and Quality Assurance in LATAM, to broaden your perspective on GMPs, Quality Assurance and the best business advice in LATAM so you can make better informed decisions.

As schemes might struggle to find information about members who are due top-ups to past transfers due to guaranteed minimum pensions equalisation, the industry is being called on to work together and help close those data gaps. Lynda Whitney, partner at Aon, and David Brooks, technical director at Broadstone, discuss what lies ahead for trustees and administrators as they try to digest the latest High Court ruling in this area. See acast.com/privacy for privacy and opt-out information.

In This Episode... We're discussing GMPs (Good Manufacturing Practices). What are they? How are they useful for importers with suppliers abroad in countries like China? What is their relation to controlling your suppliers in comparison to activities like quality audits, social compliance audits, and process audits? After listening to this episode, you'll have a grounding in what GMPs are and how to implement them yourself if you feel that they'll help you improve results from your suppliers. Show Notes 00:00 - What are GMPs? A brief explanation behind the concept. What are the basic things that must be done well and carefully when it comes to manufacturing? This is the basic idea of GMPs. They can vary based on industry and are often grounded in quality and safety. 03:18 - What industries (aside from food, medical, and pharmaceutical) are particularly benefited by using GMPs? More relevant for any product type which has high safety and/or quality requirements.  04:57 - Some similarities between GMPs and ISO 9001. GMPs may be insisted on when it comes to practical actions suppliers should focus on that an auditor will check on-site. This applies to the physical, whereas the opposite would be social compliance audits which focus very much on what people say, not necessarily what they physically do. 07:28 - Why focusing Asian suppliers on physical improvements is a good way to spur improvement. It's harder to fake - they either 'do something' better, or not. Costco is an example of a retailer who has a fairly simple GMP checklist that they ask their suppliers to follow for products which are not medical, etc. 09:14 - Are GMPs a part of the manufacturing agreement with a supplier? They may be, but can also be used during initial qualification of a potential supplier, too. Their improvement based on GMPs can be assessed over time and rewarded with more orders (or fewer). 10:24 - What list of principles might typically be included in GMPs? It will vary per industry, but for general consumer goods, it may include: How materials are stored. Segregation of conforming vs non-conforming material. Production equipment maintenance. Staff training and experience. During or after production checking schedule and method (includes sampling and testing equipment). Planning to avoid excess inventory.  Some buyers may have specific requirements based on their industry, too, in a subset of the GMP checklist. For example, checking the material purity and the molds would be key for producers of die-cast products. Any more specific and you go into the territory of process audits, but GMP checklists usually don't go that far. 16:15 - How GMPs are more superficial than process audits. GMPs are more generic, but they have a value in terms of making sure the basics are followed properly. 17:35 - Do suppliers keep records about following GMPs. Suppliers rarely admit to following GMPs, but it may happen in specific cases where GMPs are critical (such as from a safety perspective). 18:04 - What are the kinds of elements that make up the USFDA GMPs for medical devices? This gives an idea of the demands placed on suppliers of medical devices where safety is critical. Focus on documenting good manufacturing practices and quality system. This will include QC records, traceability information, preventive maintenance, images of the machinery and facility, how defective pieces are dealt with, BOM, pre-production verification records, and more. All of this goes into a technical file which is retained until required and can be updated when needed, also. For SMEs, following these GMPs would put you well above the average. 24:40 - Flexibility of GMPs for medical devices. The USFDA GMPs are purposefully flexible, as there will be a big difference in safety requirements and preventive thinking, for instance, between the production of a pacemaker and a head covering for hospital staff. 26:25 - Are such GMPs covered in ISO 13485 for medical devices? No, but a good auditor will consider them during the audit and ask questions about them. Also discussing how issues are minimized and tested for even after the product is on the market by reliability and quality engineers. 30:07 - What are food GMPs? No one standard, but a focus on hygiene is common. ISO 22001 food safety management system defines GMPs as 'prerequisites' as they are the basics that should be in place before foodstuffs are produced. They would include points like pest control, staff hygiene and controls on smoking, rubbish and waste disposal, correct water supply, and more which are specific to food production. Food GMPs often differ from one country to the next. 33:27 - GMPs' basis in common-sense. They are the basic things that no one can dispute need to happen. 34:15 - Wrapping up: How should buyers who want to implement GMPs get started? Think about your product categories. The approach will be different for general consumer goods in comparison to those that require advanced safety like food or pharmaceutical goods, for example.  List the basics that you need your manufacturers to do to a good standard. Will they be used in your ongoing re-auditing program for suppliers or with a management system audit? Consider your objectives and scope. If you're concerned mainly about how materials are handled and manufacturing is done, then implementing GMPs is appropriate, but if you need to go deeper into a supplier's capability then a quality system and/or social compliance audit may be relevant. Brainstorm and develop a checklist, organizing it by category. Audit based on the checklist and hone it over time. If you work over different product categories, the GMP checklist may need product-specific subsets added to it, too. Extra GMP information you may find helpful What Are Good Manufacturing Practices (GMPs)? Do Good Manufacturing Practices (GMP) Audits Drive Improvement? Understanding the Basics of Food GMP Food safety standards: ISO 22001, HACCP, GMP If you feel that you need help with auditing suppliers, Sofeast provides a full spectrum of factory audits for you across Asia. Get in touch with us Connect with us on LinkedIn Send us a tweet @sofeast Prefer Facebook? Check us out on FB Contact us via Sofeast's contact page Get even more great content or assistance with your own project Visit our website at Sofeast.com  Subscribe to our YouTube channel Subscribe to the podcast  There are more episodes to come, so remember to subscribe! You can do so in your favorite podcast apps here: Apple Podcasts Spotify Stitcher Google Podcasts TuneIn Deezer iHeartRADIO

This week, Stacey is joined by Igor Gorsky, Senior Consultant Val Source Inc. Stacey and Igor discuss current restrictions and guidelines for cleaning, the shift to more science risk-based approach, streamlining the cleaning process while assuring patient safety and product quality.Igor is an industry leader in Pharmaceutical and Biotechnology with broad strategic and tactical leadership experience spanning Development, Commercial Manufacturing, and Quality organizations. He has a proven record in implementing Validation Master Plans based on Risk Management and principles outlined in ICH Guidances Q8, Q9, Q10 and Q11 in variety of pharmaceutical facilities. Igor brings expertise in implementing Quality by Design in manufacturing environment throughout commercial product launch; Proven track record in building Validation organizations establishing and implementing validation policies and training programs; Direct personal interface with FDA, MHRA, ANVISA and other regulatory organizations.Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com.

NSF’s John Johnson sits down with Paul Merrick, a Chartered Mechanical Engineer with over 30 years’ industry experience, to discuss GMPs associated with engineering services during a crisis or prolonged shutdown. Paul shares key advice on how to reopen facilities after a shutdown, the key advantages and disadvantages to outsourcing, and QA’s role when it comes to outsourced engineering certificates.

‘Mfg' stands for the manufacturing date. Previously, USP guidelines required supplement manufacturers to state an expiration date, ‘Best before', ‘Use by' or ‘Sell by', date. The guidelines were revised by the FDA to include an ‘mfg' date as well. All manufacturers following the FDA's GMPs will have an mfg date mentioned on the product itself. The mfg date is an indicator of the date when the product was manufactured. To better understand the mfg meaning consider a product with “MFG 091219”. It means that the product was manufactured on September 12, 2019. Usually, supplements must be consumed within 2 years of the mentioned mfg. This general guideline is different for probiotics that need to be consumed within a year or 18 months of being manufactured. * These statements have not been evaluated by the Food & Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.

In this podcast, Tim Smith and John Cormell, discuss GMP conversion and explain: • what GMP conversion is • what trustees need to think about if they are considering converting GMPs, and • how HMRC's recent guidance on GMP equalisation affects conversion exercises.

Determining if a dietary supplement is of high quality and safe is a core issue when it comes to prescribing these products. In this interview, Dr. Robin Reddeman will describe regulatory issues, as well as details regarding Good Manufacturing Practices (GMPs). She also touches on GRAS and NDI status. In addition to being a naturopathic physician, Dr. Reddeman is a Senior Scientific and Regulatory Consultant at AIBMR Life Sciences, Inc.

Everyone who sells or makes a supplement or food, or an ingredient, is subject to FDA requirements. By now, most folks in the FDA-regulated world know the minimum level of cGMPs (current Good Manufacturing Practices). It includes things like raw material testing, specifications, batch records and finished product testing.But how do you know when your manufacturer has gone from meeting the minimum basic GMPs to the next level—what we can call Excellent Manufacturing Practices, or EMPs? 

Good laboratory practices (GLPs) may not be legally required in full for supplement testing labs to follow in the U.S., but they are best practices that quality brands should demand of their contract lab partners. As Jen Johansen, vice president of quality, regulatory and government affairs, Cyanotech Corp., explains, GLPs are a set of principles and requirements for testing procedures, facilities, personnel, methods and references standards. GLPs are part of a larger quality system to ensure test results are reliable and consistent. While GLPs are not outlined in full in the dietary supplement regulations, sections of the mandated GMPs (good manufacturing practices) overlap with GLPs.

In today's podcast Mason chats to Jeff Chilton. Jeff has been working in the medicinal mushroom industry since 1973 and is an absolute specialist in his field. Jeff is the founder of Nammex, the leading supplier of organic mushroom extracts in the world today. With over 40 years of mushroom growing experience, Jeff was one of the first people to bring mushroom extracts to the North American market. All you medicinal mushroom nerds out there make sure you catch this episode, Jeff is a deep reservoir of knowledge and insight!   The gents wax lyrical over: The ins and outs of mushroom harvesting. The difference between products made from mushroom mycelium as opposed to their fruiting body.  Cordyceps Cs-4. The inferior nature of grain grown medicinal mushroom products. The nature of the medicinal mushroom industry at large, and what to look out for in regards to quality and authenticity. Following your passion in business. Retaining your integrity in the mushroom industry. Polysaccharides and betaglucans. China as a superior source Who is Jeff Chilton ?   Resources  Q: How Can I Support The SuperFeast Podcast?   A: Tell all your friends and family and share online! We’d also love it if you could subscribe and review this podcast on iTunes. Or  check us out on Stitcher :)! Plus  we're on Spotify and Soundcloud!   Check Out The Transcript Here: Time to talk tonic herbalism people. Maybe some medicinal mushrooms and philosophy for longevity, so pour yourself a tonic and get ready to get super human, baby. Let's start the show!   Mason: Hello everybody. Welcome back to the podcast. Got one that, I've been really looking forward to doing this interview. Jeff Chilton, I'll go into a little breakdown now, rather than just jumping ahead to why I'm really into his work. He's been in the mushroom industry since 1973. When it comes to mushroom cultivation, back then, he was really pioneering. Especially, a lot of the mushrooms that we have available today via cultivation in the west.   Mason: He had a lot to do with the developing the manufacturing of those. Then in 1989, switched over to the manufacturing of medicinal mushroom extract, so he's OG in this medicinal mushroom world. There was no real trending back then. And I, like him, we met two years ago at a herbal symposium in Oregon. That's when I really ... super aware of him and just how he was just via just his own integrity and just educating the market.   Mason: He became this internal watchdog of the industry. Just in the sense of just calling out real bad practices that are going on in the medicinal mushroom industry, and still today, and educating people, so you can spot a product on the market which is telling fibs, and really doesn't have the good stuff that we have all come to know and love about medicinal mushrooms.   Mason: So NAMMEX is his company, also Real Mushrooms, and I love the fact that we can sit down as colleagues, offering medicinal mushrooms, having more at it from the Taoist perspective and Jeff just rocking gin that specialization of mushrooms and especially being such an originator of the entire industry. I really love to be able to sit down, talk with him and ask him about the history, especially he's really been shining in educating people about the difference between growing medicinal mushrooms on wood and on mycelium. And we dive into nuances of that.   Mason: Basically we talk about the industry and we talk about setting up relationships in China and just how amazing it is to be able to source really incredible, the most high quality mushrooms that you're gonna be able to get in the world outside of a wild cultivated situation. Where we are talking about medicinal qualities. Getting those from China and being able to educate people about the beauty of getting them from China. We talk a little bit about that.   Mason: Also what it's taken for us to develop the relationships with growers and farmers and so I think you'll find it really interesting hearing me from 2011, Jeff from 1989 really navigating the difference in our stories. As well we go into organic because Jeff has pioneered in getting the first certified organic mushroom supplement in the US which is really amazing. We go a little bit into that, I share my two cents on where I see organic is at. More so the reason why I like Jeff is because he's not like most companies that just think the be all and end all is paying for this little sticker, jumping through a couple of hurdles and getting the sticker on your product.   Mason: But what we call going beyond organic. And Jeff does that with the organic certification and I share my two cents on where I'm at with that whole thing. But mostly just how much I love that he's non-stop out there educating people. Not just trying to flog a product, not just trying to grow this crazy big business. But I think that's kind of inevitably happening, it's just a nice slow growth of a business. Because it has a lot of trust and it has a lot of consistency in its messaging. And we talk a lot about that and have a lot of laughs and get a couple of stories about the history of the mushroom kingdom and those mushroom people back in the day. We talk about mushroom conferences and a bunch of other things. I think you'll really enjoy it, I hope as much as I did, here's Jeff Chilton from NAMMAX.   Mason: Jeff, thanks for joining me, man.   Jeff: Hey Mason, thanks a lot for having me.   Mason: Absolute pleasure, so remind me where are you again in the world?   Jeff: I am in British Columbia, Canada. I like on Vancouver Island out on the West Coast. You and I are actually connected by the Pacific Ocean.   Mason: Vancouver Island especially, for some reason that just keeps on calling in. I keep on having friends, awesome friends and now you. You're waiting there. And I'm like "What is the pull?"   Jeff: Yeah. You have gotta come. Definitely come in our summer time because otherwise you'll just be hit by all of those things you don't like, which is rain and all the rest.   Mason: Well, it brings mushrooms, yeah?   Jeff: It's true.   Mason: When is it really on for you there? What months is it on for mushroom harvesting?   Jeff: Mushroom season is really going strong in October. First couple weeks in November still happening but then things cool off too much then it slows down and there's nothing happening. We get rains in August, which really primes things then in the last couple weeks in September we could see things starting to pop up.   Mason: All right, I love it. October, that sounds good to me. Let's dive in a little bit because we met maybe we were chatting it must've been two years ago.   Jeff: At the American Herbalist Guild Conference in Oregon, which was just awesome.   Mason: That was amazing, I mean, we were in Silverton? Is that right?   Jeff: Silverton, exactly, yeah, that's where we were.   Mason: But apparently not the witch one. No, I think that's on the other side. Tony was looking at Silverton but that's where all the witches were.   Jeff: Oh, ah   Mason: That's a different Silverton. I can't remember the name of the hotel but their grounds rolling in and the ginkgo trees, big ginkgo trees as well lining it. And then all the herbalists who came and did their herb walks were just frothing at how much they were able to go and show everyone how to forage, how to identify. Because the array of herbs there was incredible. That place is designed.   Jeff: It was absolutely designed. It was a huge property and they put in all sorts of different plants, herbs and different kinds of trees. It was a beautiful venue there are a great place to have that. Even on the Saturday night when they had a band playing and everybody was dancing. I had a great time.   Mason: That's so good, yeah. I imagine that place gets a lot of herbal symposiums going through it. And man, the best thing, the fig tree was kicking. Did you get up there and face on the fig then, during that symposium? That was the best part of it. Right next to the pine.   Jeff: Oh my goodness, no. I hardly had a chance to get outside which is back to my place where I was staying on the grounds and then down to the venue. But I was locked into my booth most of the time and talking to people. And then in the evenings it was nice. It was a fun thing. And I know you said you had a chance to get to hear Christopher Hobbs while you were there. That had to have been really great because I always enjoy seeing Chris. I know he was really busy in fact, funny thing was Chris told me, he said "God, I'm sorry I didn't spend more time with you. I ran into an old girlfriend."   Mason: Oh, right, I'm happy for him.   Jeff: Me too.   Mason: You're like, 100%, I can't contend with that. So '86 Hobbs wrote the book. Were you aware when his book 'Medicinal Mushrooms' came out, because when was NAMMAX first created?   Jeff: I started the business in 1989. I'm trying to remember whether I knew Chris at that point in time or not, but he was part of the whole herbal industry, so to speak, and Herbalist Guild and all of that back then. I wasn't nearly as much in touch with herbalists until I started my company. Before that it was just pretty much just mushroom people and all the people that were in the mushroom world over here. There are a lot of them. Mushrooms really happening. Long before the herbal industry figured it out and got wind of it.Chris was one of the first because he was an herbalist but also was interested in fungi. So that was really cool.   Mason: Yeah, I think he studied and formally became a mycologist as well.   Jeff: Well, no, he was a botanist, definitely a trained botanist and a history orf botany in his family. Herbalists and things like that. And now he went on and he got a PhD in molecular genetics.   Mason: Okay, he's going down that route. I like that book because he was really able to balance the mystical aspects of the mushroom herbal kingdom especially and then dive deep down into the science. It's something that only him and Steven Hardliner. Steven is the master at going down deep, molecular how a particular compound is interacting with a particular viral passade. And then blowing into full throttle Earth poetry in the next paragraph. It's a real gift. Going back to the 80s, you were running with the mushroom clique in America. Yeah, tell us the story.   Jeff: The thing was in the 70s... Well, first of all in the late 60s magic mushrooms were really great interest. That was one of the things that I was really studying at university. I had this interested in mushrooms in the 60s and I reading all about a man named Gordon Wasson. Are you familiar with Gordon Wasson?   Mason: Just the name and loosely, but not really.   Jeff: Yeah, so Gord Wasson was a New York banker with a Russian wife. He learned about mushrooms being used deep in the mountains of Mexico by Curanderez and went down there in the 50s and spent the next five summers down there. He classified a whole bunch of different psilocybes during that period because he took a French mycologist with him. And so, five summers. But he basically opened up this whole world of Look! Still today after thousands of years there are people in the world that are still using these psychoactive mushrooms in their healing practices. Man, that was a mindblower.   Jeff: So I was reading Watson and other people that were involved in that and they had published these books that were incredible books. I mean Watson went on to publish a book called 'Soma: Divine Mushroom of Immortality.' He published that in 1968.   Jeff: Then somebody came along a man named John Allegro came and published a book called 'Sacred Mushroom and the Cross,' which talked about mushrooms in early Christianity. So, Mason, listen, think about it for a second. In 1968 two books are published. One says that a mushroom is at the root of Christianity. The other one says a mushroom is at the root of the Hindu religion.   Jeff: And then all of a sudden from there it just... You get going forward and you find that mushrooms, you see symbols of them and you start to hear stories about them used through all sorts of different groups throughout history. Pre-history actually, because as that came out people started looking and discovering this. That was really part of my study in university because I was studying anthropology. And mycology on the side.   Jeff: Going into the 70s in Olympia, Washington where I lived and worked on this big mushroom farm there was a whole core of people that were interested in mushrooms. It was an amazing group of people. Paul Stamos is one of those people. Ultimately he and I wrote the book called 'The Mushroom Cultivator' in 1983. We even had a group. We had four people, Paul and I and two other people, where we had four different mushroom conferences. These conferences were so ... You would have enjoyed it so much. We had people there that were speaking about how to identify mushrooms. I was speaking on cultivation of mushrooms, speaking on the anthropological aspect of mushrooms. We had great people there speaking. There was Andre Wyle was at our conferences. And it was just a great time had by everybody, right? You can imagine. All these mushroom people coming together. 200 people coming together for a weekend. Amazing.   Mason: So good. I mean, it's different, you got this original crew, there's always something special when you've got the original crew.   Jeff: Yeah.   Mason: There's a medicinal mushroom symposium every year that moves around the world. It was in Colombia a couple of years ago and then in Italy. Do you know that one?   Jeff: You're actually talking about the International Medicinal Mushroom --   Mason: Conference?   Jeff: Society IMMS and you know what? And that was more of a scientific group that was formed much later. I know the principles of the group. It started somewhere around 1999. They're having a conference in China on the 18th of September this year. You should come. I'm gonna be over there at this conference. I know lots of other people are gonna be there as well. It's gonna be an interesting time. I'm gonna be giving a paper there, which will be fun. There will be lots of other people too. I don't know what time of year you go to China.   Mason: Yeah, I go in September. I think this year we've got our staff retreat in September. I'm gonna check the dates, but otherwise I've been wanting to get along anyway. I've been trying to revolve it around going to Wudang mountain and doing some Taoist training as well. This is where I've been tossing up this year, what time to get over there. But that sounds a bit serendipitous.   Jeff: Yeah, well, the conference is I believe the 18th to the 22nd of September. That's normally kind of early for us. We like to go over more in November. We go every year. November's really harvest time for a lot of mushrooms like Shiitake, Maitaki, Wood ear. A little bit later is Hericium, Lion's mane. In September it's the Reishi harvest.   Mason: Yeah, Reishi harvest is normally for us in September. Where's your Lion's mane growing? Which region?   Jeff: It's growing in Fujian province.   Mason: Okay. Ours is a little bit earlier, in September as well. In Heilongjiang. In the northeast.   Jeff: Okay, yeah, because in Fujian province it is late, late November when it's quite cold. It's back to the mountains, quite cold. Maybe up in Heilongjiang it's colder in there right?   Mason: It's chilly.   Jeff: (laughs)   Mason: That's spoken like a true Australian.   Jeff: Let's fly in and start up north there and step off. I just can't wait to get to Yunan province.   Mason: (laughs)   Jeff: I can't wait to get down into that tropical vibe. Although, nothing beats that crisp air.   Jeff: Well that's good. I'm at that point where -- I don't know when your periods of this business growth have been -- but I've been real head down, bum up in the business. Not really been in that space of upgrading my information. Of course, I'm always reading and everything, doing all these things. I feel like that's like, you're at a point in your business where you are traveling around and you're educated. You're back at that point where you're free to go and educate and then go and educate yourself non-stop, constantly, which is really nice. I'm nearly back there.   Jeff: Yeah, you know what it's like. We are so swamped right now. We've got so much demand for the product right now. We're growing and over the past two years we've hired four people, two people for lab and another person for regulatory and, can you imagine, we've got one person that's strictly regulatory affairs and deals with all the paperwork that we have to deal with. The paperwork is really monumental. We get forms from companies that are 220 questions!   Mason: Companies that you're doing business with and they wanna know, looking at purity or is it you getting stocked with them that they want all those questions answered?   Jeff: No, they qualify their suppliers. And so this is all about GMPs for the most part and how your product is manufactured. They want to know that everything is according to the GMP, quality, and the standard operating procedures and all the rest.   Mason: I think that's where Real Mushrooms. Was it your son that created Real Mushrooms?   Jeff: Real Mushrooms, yeah. Sky created Real Mushrooms in 2015 as part of NAMMAX so it's just one division of the company. He runs Real Mushrooms as well as other things because he's in training to allow me to go fishing and he can stay and do all the work.   Mason: Great. NAMMAX is providing more providing bulk for people that are putting it into products and stuff?   Jeff: We're a business to business. We sell the raw materials and then Real Mushrooms is retail products and mostly sold online. Maybe getting it into the stores at some point, but right now an online business. But we're business to business where we sell to companies that then put the raw materials out under their own brand.   Mason: Does NAMMAX do... I'm increasingly aware because I think NAMMAX... we get a lot of people asking at SuperFeast but we don't really specialize in that B2B space. But one thing I want to talk a little bit about later is a lot of people who, like NAMMAX has bridged it and made it really accessible. Especially with you and the middlemen not having to deal straight with trying to... I'm still appreciating, it took me quite a few years but you'd know the in's and out's beyond what it's like developing relationships, critiquing, getting the authenticity on the testing. Also developing a relationship based on integrity and qualifying on that level takes so long. I feel like NAMMAX has really made it possible.   Mason: I know a lot of people in Australia who are like "Ah, great, I can just go and NAMMAX can just do it all for me." Which is really great, because there's a lot of people. I like it because there's a lot of people jumping onto the bandwagon, and Australia has got this nice buffer. We don't have too much shit here, which is really good. And that's something that's nice for me to be able to say about my competitors as well. Australian community doesn't need to be as wary, I think, as the U.S. world because the U.S. is a bit...I didn't realize it's a shit fight. I know talking to you a lot back in the day, I don't think I presented that I was from SuperFeast. We were just talking about mushrooms and I was just learning a bunch off you and learning about your history.   Mason: As a company when I started out it was an absolute no-brainer that we weren't gonna use fillers, that I wasn't going to be using mycelium product myself. We'll talk about that, it has its place. Of course, growing on good-quality wood. In Australia we're just small companies. I started in Mum's spare room getting products for me and Mum. Then talking to you I was like... and then reading your blogs and really falling off the back of it just like that. Wow, because you actually really inspired me after that talk going, "Well of course, I do talk about the fact that we don't use fillers and we don't grow on grains." And all these kinds of things, but it was getting to that point I didn't realize people really needed to know the in's and out's of your product and be able to ...   Mason: After seeing what happened in America with how much trickery there is and the percentages of polysaccharides there is, lets' go into it a little bit now. You've been watching it and been the internal watchdog of the industry, which I really like. When did that first start cropping up? When did people start jumping on the mushroom bandwagon and fibbing about the levels of polysaccharides and active ingredients?   Jeff: The interesting thing was that having been in the supplement industry since 1989, the key thing for me was that I was a mushroom grower by trade. So i spent ten years as a commercial mushroom grower on a very big, big farm. Not a hobbyist growing in my basement or a closet or something like this. A commercial mushroom grower, large farm. Millions of pounds of mushrooms every year. So I knew how it all worked, I knew the economics of it all. I realized back in the late 90s, for example. Or even the early 90s that you couldn't actually produce mushrooms in North America and turn them into a supplement, because it's a dry powder it's not a fresh product. Once you dry that thing out it's 90% water you gonna get ten times as much money for that pound of mushrooms. It doesn't work in the supplement world.   Jeff: That's where going to China and I went to farms, I went to factories, I went to research institutes, I went to conferences. The 90s was just amazing to see what was going on. I went north to south, east to west. Yunan province all the way up to Jilin province. It was all over China seeing this industry and seeing the research. One of the things, you talked a bit earlier about quality how do you know. Here I am visiting these companies going to all of these conferences. I'm having people coming up to me all the time saying, "Will you buy my product? Here it is." And they just show me a brown powder and I'm just like, it's a brown powder, I don't know what it is! How can I really know what that is. And then getting to know companies and people that were genuine and you could go to their factories and see what they were doing. Especially if they were only producing mushroom products and then building the relationships to that.   Jeff: Then I turned around and back in the United States here are these companies that come along and they start to produce mycelium on sterile grain. The worst part about it is they sell it as a mushroom.   Mason: Some people might not know what, so, we're talking about the fact, which you alluded to, which I completely agree with, that the only way to make a viable super high-quality product that's a powder is doing it in China. Based on the fact that, say you have 10 or 20 kilos worth of raw product that's gonna then give you a kilo of the powdered product in the end, it's not viable in the U.S. so to make it viable in the U.S., the way it generally works is that it's grown on a grain substrate, like rice, brown rice, oats, this kind of thing.   Jeff: Yeah, and the thing is, what people need to understand is that a mushroom is just one part of this fungal organism. So the other parts would be a spore, the spore germinates in to a fine filament, those filaments come together, they create mycelium, which is the actual body of the fungus. Which normally if you're out there hunting mushrooms you never see that because it's in the ground or it's in the wood. So most people are unaware of that. But that mycelial network amasses nutrients. When the conditions are right it produces the mushroom. That's what we see because up it comes and it's like "Wow, look at that thing there!" And then that matures, it produces spores, and then we have a complete life cycle.   Jeff: The interesting part, Mason, is that growing mycelium, which is the vegetative part of this organism, on sterile grain as a mushroom grower, what that is and what that was developed as mushroom spawn. Which is like the seed that is used to grow mushrooms. Because mushrooms don't have seeds they have spores. You don't plant spores when you grow mushrooms, you plant live mycelium. The mushroom growing world, what they developed is "Okay, we'll take that live mycelium and we'll put it onto some kind of a carrier. Then that carrier we can spread into our compost or whatever it was that they're growing their mushrooms in. If you take a gallon of grain, you've got maybe thousands of grains in there you coat that with mycelium, and then you take those thousands of grains and you can mix them into a big pile of straw or compost or something. Each one of those mycelium grows off of and it grows into this thing. So that myceliated grain actually was developed in the 1930s as mushroom spawn or essentially seed to grow mushroom.   Jeff: It's an easy process, it's done in a lab and people in the United States, we can't grow mushrooms. Why don't we just take that process, we'll grow out the mycelium. Mycelium in and of itself it's got beneficial properties because it is a fungal hyphae that has beta glucans in its cell walls. If you grow it in a certain way like in liquid or something it can produce certain medicinal compounds. But when you grow it on grain and then you don't separate it out from the grain at the end of the process you end up with mostly grain powder. That's what companies started to do. They started to grow the mycelium on grain. At the end of the process they would dry it -- just like you're drying a mushroom, but -- they'd dry it, they would grind it to a powder. No mushroom there at all. No mushroom, it's just myceliated grain, and it's mostly the grain powder. Finally, the worst part about it is then they call it mushroom when they sell it.   Mason: I definitely know I've been surprised, because my first trip to the States I went and bought all the different brands. I was floored by some of the grainy non-mushroom powder that I was buying. That was like white powder, it's in your face.   Jeff: Yeah, white powder and you taste it and you're like, "How's it supposed to taste like mushroom? It tastes kind of like flour."   Mason: Yeah, it's like flour, sawdust. So are there companies doing a mycelial growth that are more on the ethical spectrum, that they're not doing a full grain wash and that they're growing on a particular grain that they're able to separate out a lot of the mycelium? I know that a lot of the mycelium is embodied grain. That's just a reality that you're not gonna be able to get rid of. But I'm trying to play that... is that possible in your experience?   Jeff: In China they grow mycelium in large tanks of liquid.   Mason: Like Cs-4 Cordycep, yeah.   Jeff: Yeah, Cs-4 Cordyceps. They've been doing that for 50 years. But the thing is that it takes a lot of money to put in a big facility that can grow and these tanks are huge and you have to have a steam generator. It's a big investment but to actually grow out the mycelium on sterilized grain does not take a lot of money, it doesn't take a lot of expertise. It's a very simple process. Anybody can do it. In my book that I published in 1983, it tells you how to manufacture mycelium on grain at home in your kitchen. It's not difficult so it's very easy and ultimately, the stuff is so cheap to produce. And these people are selling it as mushroom and making a fortune doing it. It's really immoral in my opinion, and unethical. And especially if you're calling it mushroom.   Mason: I think because we sometimes maybe look at the market and what we subconsciously are looking for when we want a mushroom and most of the studies have been on if you're like... Most of the time we're looking for a fruiting body. That's the mushroom. It's the unspoken that we know that we're talking about is the fruiting body there? And I guess there are some companies that have been quite averse or trying to sign typically validate the mycelium. When I was first kicking around all this there were people going "Look, just have it all. Have the fruiting body, have the mycelium, have all these..." and I very quickly, before I had a company was like "Mmm, no." I'm not in this to justify a particular aspect of the market or go for ease. I'm in it personally, and especially in the beginning, being a dreadful romantic, trying to connect to a herbal system, particularly Taoist tonic herbalism for me.   Jeff: Exactly. The people who grow those products and they say "Oh, we want to have all parts of this. We want to have the spore, we want to have the mushroom, we want to have the mycelium." It's like they say "It's full spectrum." Well, the problem is that they leave out the fact that (A) there is no mushroom in it, and (B) the grain! How can it be a full spectrum product if they've got all of this grain in the product? That's what they don't like to talk about. They don't like to talk about the fact that it's mostly grain and all of this other stuff about "Oh, you know, the fruit body's in there and the spore's in there." Absolutely not. It's really a lot of smoke and mirrors.   Jeff: That's what's so hard to take is that when there are people out there actually espousing that and claiming that they've got a full spectrum product when in fact it doesn't take much in the way of analysis to prove what they do and they don't have. We've run analysis and what's really interesting is if you analyze it, for example, with a proximate analysis, which is proteins, carbohydrates, fats, ash, minerals. Those products line up perfectly with the grain they're grown on.   Mason: Are there exceptions to that?   Jeff: No. All of these products and there, it's the myceliated grain products. If it's grown on brown rice it lines up with brown rice. If it's grown on oats it lines up with oats. Literally the two lines run together. The way I like to think about it too is I talk to people and I tell them what they're growing is tempeh. And they say what tempeh is, it is cooked soybeans with fungal mycelium grown on it. If you look at that tempeh and it's all white that's the mycelium but if you look at tempeh and you cut it open you can see it's mostly the soybeans. And if you were to dry it out, look, Mason, mycelium is 90% water. Just like a mushroom. The soybeans are 50% water. When you dry that tempeh out the mycelium just goes "Fffft!" Just tell me, where's the mycelium? And you've got all of these dried soybeans and you're like, well, it's mostly dried soybeans, that product.   Mason: I'm sure you get it a lot as well. Yours, there's obviously a few brands in the U.S. becoming more aware of the others. I didn't go looking for them but as you move into a market. SuperFeast, I spoke to you about it the other day. We've got so many people ... like [inaudible 00:29:50] story. I've realized in business a lot of the time it's like, same with you, I like the people. I like the unique stories. People are like "Bring SuperFeast over, there's no one doing that like what you're doing over there!" I like, yeah.   Jeff: (laughs)   Mason: And it's the same. When you're upfront about the nuances although there's a lot of companies doing medicinal mushrooms like yourself and Taoist herbs like us, medicinal mushrooms. There's nuances there and the sourcing and there's nuances in the story. What I like is, which is going to get to the polysaccharide claim, and the full spectrum claim for the people growing the mycelium. Because people are in an egoic, competitive make money mentality a lot of the time. They think they have to be everything to everyone. Versus just being very upfront. I'm always quite upfront, I don't really look at that. I don't try and standardize color or anything in any way. I don't try and standardize the constituents. I don't even sell on the percentages of constituents. I don't focus on it. I'll move more in that direction because more and more people want to be satiated. I can say yes, we test for percentages of the active ingredients to ensure that they're in alignment with the Chinese cornucopia and ensure that they're actually active. And all that kind of stuff.   Mason: But going over into the States now and hearing about all these other brands and I'm with you whenever it's growing on grain I can't get behind it. Not to be disrespectful, and I'm always trying to be really amicable in my talks. There's a place for it, but less and less can I find that place.   Jeff: And I understand what you're saying too because if a person is genuine. For example the herbalists, who are at an American Herbal AHG conference. These are people that want to provide good products, they want to provide a body of knowledge to help people. That's who you wanna be, that's who I wanna be. I'm not in this to make a lot of money. I'm not in this to build some big company and go Oh, gee, isn't this great? Because I'm selling $20 million a year of this or that. That does not excite me at all. That has no meaning for me. What has meaning for me is that I'm producing a quality product that I've been working on for years and I can tell you the product is what I say it is and I want it to help you. I want you to be able to take this product and feel confidence that you're getting what the Chinese have used in traditional Chinese medicine for thousands of years. That's what I want.   Jeff: I don't want to sell you something that is not what it really is and is a placebo and expect you to buy the product from me and I walk away going "I'm managing this great at my company. I'm making so much money and it's wonderful." No, I'm sorry, that's not me. I'm not interested. Those people turn me off. It's like the difference between being in a group of people that really understand mushrooms or herbs and being in a group of people that are just talking business and numbers and all that kind of stuff. And I don't give a shit about that.   Mason: Yeah. I think it's interesting. Watching your business I can see in the beginning it probably would've started out that everyone knew Jeff and knew your level of integrity and how you just wanted a good product. In that little circle it was like 'Great, we'll just go and get Jeff's product.' Then as you grow I think what you've done really well ... just to put it as an example of why I'm bringing this up, we're getting to this point where we're growing as a company where it's beyond Mason at the markets and everyone knows that Mason has the badass tonic herbs. Or people are coming along to the talks and all the health clique. We've started emerging.   Mason: I think you would've gone through this years ago when you emerged beyond the health clique. And it's very dramatically people aren't associating directly with you or the founder, it's the company. They don't even know or care who the founder is and therefore you need to have these things in place. We're getting to the point where everyone who's a SuperFeast customer is just like, "Yeah, we don't even care about organic, we know what you guys are doing," and we're going on that old philosophy and we're documenting that and there's all those other checks in place like independent testing for pesticides and metals and all that in place and available.   Mason: But it's getting to that point now where the people on the very outside... I still don't know if we're really gonna shift because I still personally don't care and I don't change my company for perception's sake. But you can see Wow, that organic would be really, really useful for those people on the outside. Or the testing to know what percentage of what's going on inside and being able to present that. I think we'll move in that direction. I think you've done that really well and really maintained the trust in the brand of course, and in yourself. But maintaining you there as the one that's rolling this along and not then just relying, you know, the organic certification or the percentages.   Mason: I think that's what I find really commendable, because most people then they rest on their laurels. Once they change over into, not standardizing but testing for minimum constituents like beta-glucans or organic. they then rest on that. Whereas that means nothing to me at all. Being able to talk to you I'm like, Yeah, because organic, I don't know what your take on that. I know there's some terrible organic products out there. Just the fact that we know we can go organic there's five different companies we can go to, so you just go and find the company that suits you. We can go with the company that's the hardest to jump through.   Mason: I won't go into the details of what's going on, why we're probably not going to go in that direction. For us there's so many little micro-farms that we're being nimble with whom we're working with. When we're beyond mushrooms we've got a lot of other herbs going on. We need to cut that farm out if they need to move on and do something else and we'll go and we've got that team to go around and constantly go and find these people. So every time we want to nimbly adapt and go down a different direction when someone's doing a little more traditionally than the other person, all right, get the organic certify up. Or lie, which is what I think a lot of people are doing. They get the organic certification, then when they change up those little farmers, because we're dealing with independent farmers as well, not a company that can provide the organic certification. I don't know why I went on that rant. So that's why we're not going on down that route.   Mason: It's something I see. I know there's a bunch of companies who are coming to NAMMAX, which I think is just been so good for the Australian industry. For people to know that they're very quickly going to be introducing a really good quality. You can tick off the organic but I hate it when it's just organic that they are going for and not just an incredible product with a story behind it as well. So I really commend you for offering that out.   Jeff: I've always really believed in chemical-free food. Organic is more than just chemical-free it's how it's grown. When you're growing out of soil it's building the soil and not just depleting it. For me organics is a holistic way of looking at things. I've always considered that to be very important and I support that type of agriculture no matter what it is. A lot of these companies that are producing myceliated grain, they're organically certified!   Jeff: It doesn't necessarily mean that it's going to be a great product. These companies have what I call all sorts of merit badges. 'We're big and we're organic, we're kosher, we're this, we're that,' which ultimately means nothing at all. There's a lot more to it than just that. The one thing I really like about what you're doing too is that you're introducing the philosophy of it and that's something that you really believe in. That to me is important and that's what people look at. They look at who's behind the company and what that person has to say, is that person ethical, righteous, person or not. You're not up there as a smooth talking business salesman or anything like that, right?   Mason: You should see me try and sell something I don't like. I'm a bumbling mess. I think I told you that back in the markets people used to say god-made...you could sell ice to the Eskimos. But I'm terrible if I'm not talking about herbs or philosophy behind it.   Jeff: That's because you're doing something you believe in. That's where everybody should be. Not everybody has that opportunity, but if you can have that opportunity. I was lucky enough that I followed my passion and I didn't do that because I wanted to be rich. I did it because I loved it. I always say to people, if you really like to do something, whatever it is, just do it. Follow your passion. Maybe you're going to be poor for a long time. Make something that you feel good about.   Mason: Honestly, and I really mean it not just because you're on the podcast talking it up or trying to flatter you. But when I met you, you had a happy disposition to be in business that long. In the beginning I was trying to escape the business side of things. Quite scared about having a business and not coming out the other end alive. You have a sunny disposition and you still have control of your company and the standards and you're still educating about the same thing that you're educating, of course it's evolved, but you were educating about beforehand. And there's something that I've learned a bit about in that. There's something humbling and nice about not being in that pursuit for aggressive growth while still growing at a nice, sustainable rate. But staying true to what you were doing in the first place. I educate about basics of herbalism and medicinal mushrooms in the beginning and then I'll move on and doing other things. The more I go along the more I want to settle back into doing what I did all along.   Mason: I've got a weird thing about going back to the organic, I'll almost shy away from something if it's organic because I see it as a marketing ploy a lot of the time. And I think it is a lot of the time. With little things. When growing Lion's mane there's a lot of people who will use organic fungicide because they don't pick when they're watering out to the Lion's mane. I like to use this example because we don't have a plastic covering, it's just a straw and a hut to keep it nice and dark and it gets watered. That's the only part that gets watered. And one of the things I talked about in the beginning with Lion's mane, I just heard about it through the grapevine, that fungicide is needed if you're watering straw a lot of the time in order to, all right, we know why fungus grows. But found someone who wasn't doing that and found people who were doing organic Lion's mane who were using organic fungicide on the huts. Little things like that they get me so dejected about the marketing ploy behind it. But I think you're the one organic product that I would be over the moon to use.   Mason: And the other example is Ron Teeguarden. I think we talked about him. He was such a rogue in the industry herbally. You were telling me about the acupuncture when he was offering acupuncture because he's a barefoot herbalist and all the acupuncture's guilds are like "Screw you, you need to be regulated." And he's like "Hey."   Jeff: I know, it might've been somebody when you were in LA but it wasn't me. I don't know Ron that well. He's been around a long time. He's done his own thing, he's not out at the shows or anything like that. He's very well-known and in a sense he's been the herbalist to the stars. He's in Los Angeles, right? A lot of people in Los Angeles that are into herbal medicine and living properly in term of what they eat and things like that. They would go to Ron and Ron has one of the very first herb bars where you can walk in and have this type of a drink or that type of a drink. He was really in it very early and doing stuff that nobody else was. He was an outlier in that sense. I don't think he really needed to go into the industry proper. He's done a little more now that before. He didn't have to.   Mason: He, on the level of sourcing philosophy. I bumped into him years ago. I was at that place where I was starting to grow, people are asking why I'm getting my herbs from China and people asking me if I'm organic and all these kinds of things. I want to keep on doubling down on my philosophy, what I'm doing here. One thing that I drew from yourself as well and then be proactive and educating the market. Not in pushing your own product, just generally being happy about the market being educated as well. And Ron was like...In fact I talked with him for about five minutes. More or less he was like "Listen, if you have that spark," I remember, "do not deviate from that sourcing philosophy." And it really stuck with me and from that day I did. I doubled down and I was not going to try and... I'm going to continue to not worry about what's going on and just do me. It's a lot of fun. I was at Dragon Herbs Tonic Bar about three weeks ago. I frequent the Hollywood one when I'm in L.A.   Mason: Before we go too far off the mycelium grown, one of the things you've really educated, not only the market, but businesses in the market around medicinal mushrooms in the market, is how to identify a true polysaccharide read on medicinal mushrooms. Rather than people including 60% polysaccharides or even 30%, yet when you go down into the class of beta-glucan it's actually been tested you've been hoodwinked and they've gone dry from age or whatever. Can you talk a little bit about that?   Jeff: This is something in the herbal industry too that you learn right away, and I learned it back in the 90s, was that so many herbal extracts, when you make the extract they oftentimes need some kind of a stabilizer. Otherwise they can get gummy, they can jut come together if it's a powder. Putting a carrier with a lot of extracts was pretty common. What happened was sometimes companies would cheat a little bit. The next thing you know instead of 10% carrier it was 50% carrier or 80% carrier. And they're not revealing that to anybody. You think you're getting an herbal extract, not just mushroom extract, an herbal extract and it ends up being mostly maltodextrin or dextrose or something like that, and they're not telling you, then it is really deceptive. So there's a lot of companies that were doing that in the industry.   Jeff: As I went along, the whole time that I'm working with people in China I'm like, "Look, I want extracts where we aren't using any carriers. It has to be made in a certain way," because I'm looking for the pure essence. In traditional Chinese medicine they take the herbs and they throw it in a pot and they boil it up and pour it out and "Here, drink this!" There's no carriers in there.   Mason: That's right, not sliding agents.   Jeff: That's right. If you have to put something in a capsule you've got 150 milligrams of different types of fillers and binders and flow agents. Putting it into a pouch is so nice because then you don't have to put those things in with it. It's just the pure herb. Early on in the 90s everybody's testing for polysaccharides and nobody's testing for beta-glucans. And beta-glucan is a polysaccharide. Unfortunately all these carriers are polysaccharides too. A lot of people can hide that from you that you've got carriers on their product. No, no, we don't use carriers, it's 100% mushrooms, stuff like that. That's where with any kind of supplier you have to build up a level of trust. Like I say, they show you a brown powder and say. "Here's our product, it's shiitake mushroom extract. Isn't it great?" You can test it.   Jeff: This is the thing, Mason, it's not like you can take a mushroom product other than a reishi extract, consume it, and then a few hours later or a day later go, "Wow, yeah! Did I ever get a kick out of that!" No, it doesn't work that way. You can organoleptically, I can taste the shiitake extract and I can tell you yeah, that's definitely essence of shiitake. Or with reishi it's so bitter I can taste all those bitter notes in that reishi extract, that is an awesome extract.   Jeff: I used to give a reishi extract to a friend of mine who was a deep herbalist making his own liquid extracts and a big business ultimately. He'd taste some of my extracts in the beginning and he'd go, "Not bad, but it tastes a little bit burnt." And I'm like, "Oh shit." When it was dried it was maybe in the oven a little longer, and he could pick up on it. I thought that tastes pretty good. That was in the early days when I didn't know any better. I thought it's great and high triterpenes and all this. He'd go "Yeah, it tastes a little bit burnt." Those kind of things teach you a little bit about, okay, how's it made. Let me tell you, in the 90s the facilities that were making herbal extracts were nasty. They were old facilities   Mason: Not too much GMP regulation back in those days.   Jeff: It wasn't like stainless steel everywhere, no. Everywhere was dark from all the herbs they'd been cooking for who knows how many years. Now all that's been torn down and you see nothing but brand new factories in China. Everything is stainless steel and it's beautiful and there's none of that anymore. But back then, actually, it wasn't until we got the megazyme test and I started using that. And that was in 2012 or 2013. Up until that point I thought, well, the polysaccharide number was high, that's great. Then we starting testing the products and that's where we really pulled back the curtain. My main supplier, awesome! The test results we got from that. Beta-glucan and alpha-glucan and the alpha-glucan, that was where any of the carriers were revealed.   Jeff: And then another company that was supplying me with some products, only a few, not many, fortunately. And was swearing up and down they never used any carrier. Jesus, their alpha-glucan level was way up there. I was shocked and really upset because I thought their product was good because occasionally I'd test it for polysaccharides it was 50-60% and I was thinking, great product. I could taste it, it tasted okay. Nothing but mushrooms they were producing. But here they were. They were putting them on a carrier and telling me they weren't. That's the kind of thing that you face when you're over there.   Jeff: How do you qualify these products? You can go to the factory. They can show you around, you can look at all the mushrooms in their warehouse, you can look at them cooking these things up, the final products. They don't show you the bags and bags of maltodextrin that are hidden back in the warehouse somewhere that they're using as a carrier for the liquid extract. That literally pulled back the curtain and I went and confronted that with them. They claim no. Finally they actually admitted it and I'm like, okay, see you later. I'm not buying another product from you because you lied to me. Fortunately it was a secondary supplier. They weren't my main supplier at all, but I needed a secondary supplier. I visited them and it was all mushrooms that they were doing and they were in the heart of mushroom country and it was nothing but mushroom. Yet they had all these carriers in there. I was really upset not only with them but with myself because I got taken in by it too. And that's what you have to do.   Jeff: Look, Mason, have you ever been at Ali Baba and looked at all the mushroom products being sold?   Mason: It's always funny, and as you know, everyone's jumping onto the bandwagon right now. You can see people trawling through Ali Baba going "Oh, just tell me which one is awesome." I haven't been in there in a long time. I got curious, to be honest. I think we were in the office having afternoon drinks and seeing what was on Ali Baba. It is insane.   Jeff: It's totally insane. So many companies selling mushroom extracts. Sometimes they're selling at prices where you're like, "No, wait a minute, you can't sell me that extract for $20 for a 10:1 extract. That's impossible. You load it up with starch, that's quite possible, right? That's where analysis, for me, has been very helpful. Especially the beta-glucan analysis because that gives me that alpha-glucan which is the whole carrier. That's what unmasked all of those myceliated grain products. There's definitely a place for analysis. There's also a place for getting to know the grower. I don't believe in organic pesticides. I don't give a shit. Don't use whatever it is, you have to grow this. I know it's more difficult but you have to grow this without sprays and all that.   Jeff: The thing about China is that when you're traveling through China and I've been back in the mountains in all these different places and you go back and you look down and this little valley and here's this beautiful rice fields down there and you're going "Oh, isn't it great, back here. Everything's idyllic." And then you see somebody walking through the rice field and they've got a backpack sprayer. And they're going along spraying chemicals on this rice crop. I'm like, "Ugh, shit. Really? Do you have to do that?" And I think to myself, even the smallest growers out there are using some chemicals. That's where I'm like... And I want to be sure. And that's where we test and test to make sure that everything is staying on track because these things can slip in. Somebody can cheat. You have to ride herd on the whole thing. Otherwise it can slip right through your fingers.   Jeff: That's been good for me in the sense of having an organic product that has meant that we put these constraints on the people that we work with. We say look if your product shows one of these things in there I'm sorry we're not selling it. If you and if you shipped it over to us and we find it in there after you've done the testing that's all good and we find it in there it goes the landfill I'm sorry, we can't sell it. That has been a really good quality, that's how we keep that quality up. In that sense I kind of believe in it all and think it's important. It helps us keep the product a little bit more real.   Mason: As you say said there's all these things that can go by... even though it is organic, you can get organic pesticides and all this kind of stuff. I have taken your product and of course I really love it. You know that you're going to go that extra mile with it. It's a trip around it, there's a stigma around China is isn't that whole thing polluted?   Jeff: Well, that's the other side of it right now, Mason. People are so afraid of anything coming out of China that this gives them a little bit more confidence in it. They can say what they want about organic and all but we've got pesticide tests that can demonstrate what it is and of course the always have to do heavy metals and micros and all of that.   Mason: Alpha-toxins   Jeff: For us, especially as a raw material supplier to companies large and small we have to be able to give them confidence because you know they're selling a Chinese product that they buy from us and lot of people are just like you know when it comes to China it's like no no no no it's like not going to do it so I have to talk to a lot of people. And I say, well, hey look. There's products in the United States that are absolutely full of chemicals. So it doesn't matter where it's grown. It matters where it's grown but it's not this country or that country. You can grow good, clean products anywhere in the world if you're doing it properly.   Mason: It's so good. Of course people are realizing that the ultimate Chinese herbs and medicinal mushrooms are going to be coming out of China. I really like how it's still dominating and making it really easy for people to get One thing that's organic and Two very quickly have all those things to provide so enough people are going to be able to go, Oh, okay, so it's from China and we can trust it. That's something that makes it really easy, because people are going to jump on the mushroom bandwagon. We found it as well, a similar thing. People want to come, they're like okay, tell us about Chins. Okay, tested three times for pesticides before it comes to market, each batch. Plus here in Australia the TGA facility and heavy metals and alpha-toxins and microbes. At some point people go "Hmm, shit, okay." And testing of the water. And when we can going and doing radiation testing in the areas. And then going live and seeing pictures of you at your reishi farm is magic.   Mason: When I was going live around China going, you know we're still going up while we're outside the mountains going to the fields where the eucommia bark trees were grown or up in Yunnan. Just drove five hours in the middle of nowhere to get to the poria farm, where there's wild pine and people are going "Holy shit! Look at that land! The land of the dragon. It's calling me. It's real." All of a sudden popping that thing that first of all, yes, you just need to be vigilant, that's absolutely number one. I've only changed suppliers once. In the beginning I found someone I had really enjoyed their product. And then what I've decided was one of my areas in going forth is I need someone that could absolutely school me. If I'm requesting things and they weren't able to "bang" school me on that immediately, then I'm not going to be able to do business.   Mason: And it got to this point where I was confirming no municipal water. Only springs, only well water. Only creek water in the area. Nothing from the tap every touching the crops. At one point "Okay, sometimes that's a bit hard." I was like "All right, I'm gonna change now." That's when I started going down that route and ended up... developing relationships, developing a friendship first, understanding the intent behind the philosophy behind the business, understanding who owns the business that you're going to be dealing with and what their motives are and what their history is. These are the things where people don't realize what goes into it. People go "Can you tell me your supplier?" And you're like   Jeff: (laughs)   Mason: At this point it's not about me being scared about you having access to that supplier but so much has gone into this relationship. It's not just about finding someone and sourcing off them. Although, it's nice and easy to do that. If I was beginning right now I'd love to be buying just from suppliers on NAMMAX because it's cool. All the certificates, all the independents, and then all the years of vetting and tweaking that leads to this point where trust is inevitable and you become even more switched on to what to look for if anything ever comes up. If anything slips or changes you know the questions to ask and where the slip in quality could possibly be. And large ways you know how to put things in place that would stop that from ever happening to begin with. It's an interesting industry.   Jeff: We go there every year and we'll do an audit. We'll visit farms, the factory we'll be sure we confer with our partners to make sure everything is good. This year we're at the point where we're hiring someone to be on the ground in China that will do a lot of checking and stuff for us on a regular basis. More regular than us going over there once a year. It's gotten to a point where we really need that coverage of somebody right there that we can say "Can you go out to this farm or this factory?" Also, communications because sometimes communications... although some of our partners speak English but some of them not so well and then they have to use a go-between and that's not always the best. So we're gonna have somebody now that's right there in China and can do that for us. Can you imagine going to China and traveling around without having somebody with you to help you through the liaise and talk?   Mason: I have the best intentions of getting my Mandarin up to scratch and as soon as I'm out of it, it all slips out of my head. I haven't fully entered into that poetic language realm. The language is sticking. Can you speak Chinese?   Jeff: No, I speak Spanish, but Sky's learning Chinese. He has three classes a week, an hour each class with a Chinese speaker he does it over Zoom or something like that. He's very diligent about it. We get over there. He's speaking with them in Chinese and they love it. He's learning more, but unless you actually go and live somewhere for a while it's always tough. I've been thinking about it. You go over and spend two weeks, three weeks, whatever, then you leave. That's nothing in terms of really getting in and learning a language. That's swimming on the surface.   Mason: I gotta get onto it because I'm gonna do some Taoist training there.   Jeff: Yeah, that'd be really cool. You're young enough that you still can do that. I'm way beyond doing anything like that.   Mason: Come on, they'd love you up in the temple.   Jeff: Not only that, where I love to be is in Patagonia   Mason: Dude, that's the other place my heart lies, down in Patagonia. I want to become an old Argentinian man. I want to become a cowboy.   Jeff: Exactly, I know where we can get some horses, Mason, so let me know.   Mason: All right, that's it. That's on. China this year, maybe Patagonia next year.   Jeff: Yeah, two years ago Andrea and I went out and spent the day with, we had a gaucho that took us out. We went all over this one area. It was a hot day too. We were on horseback the whole time, cruising through, very slow. Slow living at its best, right?   Mason: Yeah, that's it. Drinking, eating a lot of meat, drinking a lot of yerba mate.   Jeff: Yeah, when you're on a horse you're not going to go very fast. You're going to cruise along. It's life in the slow lane.   Mason: I love it. So before we finish up is there anything that is coming up now that's exciting you about educating people about this market and about this industry with medicinal mushrooms?   Jeff: People really still need a lot of education with mushroom. Part of what I do too which I really like is I talk about the nutritional value of mushrooms. My thing too is eat mushrooms. I think mushrooms may be the missing link in terms of food. A lot of people are like, fungus, never eat it, right? And I'm like, "Dude, you've gotta get on and eat mushrooms, it's a fabulous food. They've got great benefits, you get medicinal benefits as well as nutritional benefits." That's the key for me, I'm pushing that really hard when I talk to people, saying "No, it's a fabulous food." And in China they have this whole thing of food is medicine.   Jeff: That's in Ancient Greece too. Food as your medicine. Everything that you take into your body should be something that is beneficial. And medicine as a very loose way in terms of it's feeding you and keeping you healthy. And that's what we should all be thinking about. What we consume is keeping us healthy and we should look at our food as that. That's providing me with all of these benefits. I say if you want a supplement, you feel you need more, that's great. You can supplement. But definitely use mushrooms for food. That's a big category for me.   Jeff: As a mushroom grower, can you imagine? I'm working on an agaricus farm. For ten years every day I'm going in I'm going through the rooms and each room ultimately is producing 20,000 pounds of mushrooms. There's mushrooms everywhere around me growing and I'm stoked. I love this. I've got mushrooms that I'm eating all the time. I've even got small beds of mushrooms that I bring stuff home and I'm growing them in my house because it's so interesting to me. The farm I was on it wasn't just an agaricus, we had a scientist that was growing shiitake and maikitake and oyster mushrooms. Back in the 70s when those weren't even on the markets anywhere. And I had access to these mushrooms. Besides the wild mushrooms that we were navigating. I'm like, make them part of your diet because it's a wonderful food.   Jeff: That's my message to people is this is a forgotten food, bring it home.   Mason: I love it so much. Thanks for reaching out, I really appreciate you reaching out and having you on here. It's not only do I admire you as a person, admire what you've done and your business. I spoke to you a little bit about it. I like talking to the other people who are perceived competitors. There's so much room in this market and everyone's doing their own thing and has their own story. This whole red ocean we have to fight over a scrap of people who are going to be buying mushrooms and not focusing on educating together is absolutely ridiculous. It's always awesome to meet people who trail-blazed that attitude in the industry. Calling out people that are bullshitting and then coming together and educating together and getting the world healthy together in our little way. There's something really nice about that that makes it possible to be in business for so much time, for so long, see so much shit yet still have such a positive attitude about it.   Jeff: That's absolutely right. I really love what you're doing too and I love the whole Taoist part of what you're taking to people and bringing to people. That philosophy is really awesome. That's what brings something really unique. When I hear you talking about mushrooms up around, what's the lake up there in the mountains?   Mason: Mumbai   Jeff: Yeah, that was so cool and you're hanging out there, talking about the mushrooms really excited about it all. That is really special. I love your energy, Mason, I'm really happy that we've been able to get together and have these meet-ups, speak and let's carry it on, let's keep doing it and stay in touch for sure.   Mason: Absolutely. We'll get some videos in another podcast together, 100%. I'll go check out these dates, see if I can swing a   Jeff: I'll send you the info on it so that you can check it out. If you can come you'll have a ball because there's gonna be lots of mushroom peop

The Dietary Supplement Health and Education Act of 1994 (DSHEA) created a regulatory need for supplement safety testing, but the GMPs (good manufacturing practices), issued in 2007, set a fire in the industry to partner with supplement testing labs that meet high quality standards. Yet, without FDA audits of third-party labs for GMP compliance, labs may not be feeling the burning desire to fully comply with regulations. Elan Sudberg, CEO of Alkemist Labs, a contract testing laboratory specializing in plant authentication, said FDA should be conducting more audits of supplement testing labs to ensure compliance. A recent warning letter sent to ABC Testing may signal the start of this welcome trend. In this podcast, Sudberg discuses lab audits and other aspects of DSHEA that affect labs operations.

The Dietary Supplement Health and Education Act of 1994’s (DSHEA) requirement for supplement manufacturers to establish GMPs (good manufacturing practices) took the supplement industry from a loosely regulatory industry to one with complex rules for product safety and quality, according to Robin Koon, executive vice president of sales and marketing, Best Formulations. Yet, Koon, a man who works with the law every day, added, the law could have been improved by better defining vague terms and requiring independent testing. In this podcast with Sandy Almendarez, editor in chief, INSIDER, Koon discusses DSHEA in honor of its 25th anniversary.

The Dietary Supplement Health and Education Act of 1994 (DSHEA) gave FDA the authority to issue cGMP (current good manufacturing practice) requirements for dietary supplements, which the agency did in 2007. Tara Lin Couch, Ph.D., senior director of dietary supplement and tobacco services, EAS Consulting, remembers the issuance of cGMPs as a major disruptor of supplement manufacturing, even for those brands that previously followed pharmaceutical GMPs. In this podcast, Couch discusses the transition from pre-GMPs to post-GMPs, how manufacturing has become more sophisticated in the past 25 years and that DSHEA’s biggest omission was not including raw material suppliers.

Mickey Schuett, president of GBMM Brokers and Consulting, talks with INSIDER editor Todd Runestad about the business of hemp. Schuett consults with many hemp-derived CBD companies. Here we discuss the following issues: • How the evangelical community is selling hemp. • How start-ups are not familiar with GMPs or even the business of taking ingredients to finished products. • Problems abiding by traceability practices and claims. • The value of lawyering up. • Whether the pharmaceutical CBD a good thing or a bad thing for CBD supplements.

Supplement brands are required to evaluate their products for safety under federally mandated GMPs (good manufacturing practices), but many brands don’t have the expertise or equipment in house to conduct appropriate tests. Brands can turn to third-party contract laboratories to conduct these assays, but selecting the right partner is crucial for safety, legal and—often—financial success. In this podcast, Blake Ebersole, president of NaturPro Scientific, discusses the selection process and how a supplement brand can chose the best contract lab. With Sandy Almendarez, editor in chief, INSIDER, Ebersole covers: • Why contract labs need to be verified and evaluated like every other supplier the supplement brand uses • How long it usually takes a brand to research, interview and choose a contract lab • When it’s OK to conduct a paper audit and when it makes sense to conduct an onsite audit of a contract lab.

Are you creating the conditions to create safe food? Well, that's what GMPs do! Tune in to find out the actions you need to take to make a difference. Listeners that stick out through the end will find out how to get our special bonus Facilities SOP!

GMPs (good manufacturing practices) require an own label distributor/brand holder to test their products with scientifically valid methods, but it’s up to brands to decide if it’s best to test in house or by using a third-party lab. A lot of factors that go into that decision, including time, resources, expertise and equipment. Aaron Secrist, vice president of quality and regulatory affairs, NOW Foods discusses the resources that a brand needs to set up an inhouse lab and when it makes sense for a brand to use a contract lab rather than keep the testing in house. Secrist and Sandy Almendarez, editor in-chief, INSIDER, cover: • The pros and cons of both in-house and outside third-party contract lab testing • What GMPs specially outline for supplement testing • What to look for when entering a partnership with a third-party contract lab

Welcome to the third episode of Automating Quality. Today’s topic is phase appropriate quality — a topic that is especially relevant for anyone in the life sciences industry. Mandy is joined by her co-host, Philippe Gaudreau, CEO of Solabs; and industry veteran, and the Vice President of Quality and Compliance from Eirion Therapeutics, Mary Senica.   In this episode, Mandy and Mary take a deep dive into a lot of critical components of quality and supporting processes. Mary gives her advice to growing companies and explains how to design processes so they’re appropriate for your organization or the product that you’re manufacturing.   There’s a lot of fantastic takeaways this week, such as: key factors to consider when looking to implement an electronic solution, how to determine when a software solution is warranted within a company, what makes a successful training program, and the basic principles to consider as part of a company’s CMC practices.   Key Takeaways: [:20] About today’s guest, Mary Senica. [1:09] About Mary’s background and industry experience, and her primary role at Eirion Therapeutics. [2:36] What are the specifics GMPs and regulatory guidance related to the drug development process? [4:18] When looking for an electronic answer or solution to a compliance system, what are some key factors to consider? [10:10] How to determine when a software solution is warranted within a company. [16:58] Why it is so important to implement a system that allows everyone to function together effectively. [18:34] What makes a successful training program. [22:05] What are the expectations for GMP equipment as a company moves through the phases of the product development life cycle? [26:06] The basic principles that must be considered as part of a company’s CMC practices. [28:50] What advice Mary would give a growing organization as they mature through the product life cycle (in regard to implementing key electronic solutions.) [31:48] Wrapping up the episode with Mandy, how to contact Mary and about next week’s episode.   Mentioned in this Episode: Eirion Therapeutics GMP CFR CMC FDA.gov Previous AQ Episode: Optimizing Compliance When Implementing an Automated Training Solution with Jay Turner AQ Episode 1: Change Management with Rachel Fountain Mary Senica’s Linkedin Mandy.Podcast@Solabs.com

The Food Safety Modernization Act (FSMA), which became law in 2011, increased the regulatory requirements that food—and supplement—manufacturers must follow to ensure food safety. These risk-based preventative measures accompany the good manufacturing practices (GMPs) previously required by law. In this podcast, John Atwater, Ph.D., senior director of verification programs, USP (U.S. Pharmacopeia), discusses the new FSMA rules and how supplement brands can ensure their products meet all product requirements. Atwater and Sandy Almendarez, editor in chief, INSIDER, cover: • The differences between GMP and FSMA requirements • An overview of the FSMA obligations, and how brands can ensure their products meet these conditions • Working with contract manufacturers to ensure GMP and FSMA requirements are met.

Richard Goldstein looks at the Government’s recently published consultation on a proposed method by which it believes schemes could convert GMPs into ordinary scheme benefits and simultaneously satisfy any duties they may have to treat men and women equally in relation to GMPs built up from 17 May 1990 onwards.

Kritik mot GMPs slutsatser från FBI, RRV och Robert Ressler See acast.com/privacy for privacy and opt-out information.

An overview of the FDA Draft Guidance on cGMPs for Combination Products, released in January 2015. Learn how to decide which GMPs win when working with devices where both drug and device regulations apply.   Link to FDA Draft Guidance: Current Good Manufacturing Practice Requirements for Combination Products http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM429304.pdf    .

The Return of Laura Bentley and Troy Clark Join GHB for Haunted Whispers as he is rejoined by Laura Bentley and Troy Clark from Innovative Paranormal Research and hosts of the upcoming event Whispers from the Past: An All Star Weekend at the historic Rippavilla Plantation located at 5700 Main Street, Spring Hill, Tennessee 37174 on Oct 25 and 26th 2014. They will talk about the history of the location, the event, who's going to be there, how you can be there too and about their own history with the paranormal. Troy is currently with the group I.P.R.  We handle Investigations within a 3 hr radius in the Nashville TN area and have an affiliation with TAPS. Laura Bentley - I was hooked on knowing more about the paranormal so I started watching all the programs and reading all I could about it. I went on my first investigation as a guest at Rippavilla Plantation around April 2011.  After that I was drawn to the old plantation home of the Cheairs family. I happened to be a paid guest again in March of 2012 and dropped hints that I would love to volunteer any time I was needed I am now the resident paranormal investigator at Rippavilla Plantation in Spring Hill, TN. This time they will be joined by Paul Browning, a resident of Clarksville, Tennessee has been actively working in the study of ghostly phenomena since 2005.  

Rob considers himself an average guy who just happens to be able to communicate with those who passed. He calls himself a "medium rare" because he's still learning how to meditate for more messages, but he passes messages on when he gets them. He has also been able to sketch out what a ghost or spirit looks like and has connected with many people and dogs and cats! He's not a medium who makes appointments or gives readings for money, he just gives them when spirits or ghosts come to him (The difference between them is something he explains in his books). Often he'll get messages whenever someone emails him. He belongs to the Inspired Ghost Tracking group and helps cross ghosts over on private investigations. By trade he's a meteorologist, so he explains the facets of entities using science. He's had the ability since he was a teenager, when his grandfather appeared to him 6 months after he passed. One of his big focuses is on pets. Rob had a dog that was tragically killed as a puppy and who became the world's best canine communicator. He opened the door for other dogs and cats to give messages for others that he's proven over and over. Rob enjoys activities with his partner and their dogs, work with dog rescues, ghost walks in various cities and visits to historic houses and sites to see who is still lingering behind.  Rob enjoys exercise, a good cup of coffee, paperback mysteries, talking about ghosts and spirits, weather, superheroes and still reads and collects comic books. In fact, since he was a boy, one of his favorite superheroes has always been the ghostly avenger created in the 1940s called "The Specter." The Ghosts and Spirits Blog: http://ghostsandspiritsinsights.blogspot.com/ His New Book "Pets and the Afterlife" is now available. 

Meet Luke and Mom On this edition of Haunted Whispers with GHB the show is pre-recorded at the Heritage Society of Essex and Middle River Museum where GHB has a show reversal. Meet Luke and his Mom as they sit down and interview GHB about ghost hunting. Luke is 7 and has been interested in all things ghost hunting after watching an episode of “Ghost Hunters”. His Mom reached out to GHB and asked if he could sit down and talk to him about ghosts and hunting them. What comes from the talk in interesting and even Mom is surprised by what is reveled when Luke talks about what happens in their house. This show is live and the live chat at www.liveparanormal.com will be up and running during the show. But we will not be taking calls for this show. This is the first time the show has been on the road. Please comment on this edition of Haunted Whispers with GHB if you enjoyed it.

Trainer: Senior QA Manager Svetlana Walsh You should care about what you're putting into your body. Rest assured, Isagenix does, too. We have a dedicated team of research and development specialists who ensure evidence-based nutrition research and formula quality assurance touches every product's purity and potency. Learn what makes up the Isagenix no-compromise policy, how Isagenix selects raw materials, how Isagenix identifies sustainable suppliers, how Isagenix qualifies manufacturers, what GMPs are and how Isagenix meets them, what makes up third-party testing of raw materials, and why finished product quality verification is important. Listeners will be prepped to explain the science to their teams and better understand the exemplary research-backed nutrition found in Isagenix products.For more information on Isagenix products, visit IsagenixHealth.net.

Rotting mudsills, GMPs, and fuzzy bricks explained

At Expo West recently, Shane Starling sat down with industry stalwart, Loren Israelsen, to discuss the Obama effect, Senator Richard Durbin of Illinois, the “flyspeck” that is the Dietary Supplements and Health Education Act (DSHEA), GMPs, oh, and the economic situation.

The Food and Drug Administration (FDA) has been criticized for not enforcing Good Manufacturing Practises, but according to the FDA’s Brad Williams, boosted funding means FDA inspectors may be about to “saturate the field”. He spoke with Shane Starling at Expo West.

Many medium and small dietary supplement companies are still not close to meeting new GMP requirements, despite the looming deadlines. Lorraine Heller speaks to industry members about the major challenges that remain, and the next steps that should be taken.