Compliance
Supply Chain Management for Homeopathy, Part 1 of 4
By Tim Clarot, Industry Consultant Empty shelves in supermarkets, cars selling at above list price, and a critical shortage of shipping containers are some of the visible effects of a supply chain breaking down because of COVID-19. Consider, then, how much more important supply chain issues are when you manufacture readm more…
Read MoreFDA’s Growing Expertise in Homeopathic Manufacturing
By George Bernstein, PhD If you have participated in AAHP Summits over the past couple of years, you are no doubt aware that FDA has raised the bar regarding compliance by homeopathic manufacturers with 21 CFR Part 211 (GMPs). I have been present in the audit room during FDA readm more…
Read MoreIntroducing a New Series on Supply Chain Management
By Mark Land, AAHP President This month, we’re kicking off a series of articles on supply chain management. Penned by Tim Clarot, who spent 20 years managing a virtual supply chain for one of the most popular homeopathic brands, these articles will be both insightful and instructional. We also hear readm more…
Read MoreIt’s Time to Renew FDA Drug Establishment Registrations!
By Leonard Krause, FDA Connect, Inc. If you haven’t renewed your FDA Drug Establishment Registration and certified your existing drug products, it’s not too late (or too early) to start. According to FDA, “The annual drug registration renewal period is now open through Dec. 31, 2021. To keep drug registration readm more…
Read MoreDilution Process Validation Is Complex and Data Driven
By Mark Land, AAHP President There are more than 1,300 substances currently approved for inclusion within the Homeopathic Pharmacopoeia of the United States (HPUS). Based on discussions with homeopathic manufacturers, many companies work with 300 and 500 different substances. Because each manufacturer works with a different list of substances, most readm more…
Read MoreNew FDA Report on the State of Pharmaceutical Quality Fiscal Year 2020
By Mark Land, AAHP President The US FDA’s Office of Pharmaceutical Quality published its 2020 report on the state of pharmaceutical quality on August 17, 2021. Homeopathic drug products are mentioned three times. Readers may recall that the 2019 report introduced a comparison of Site Inspection Scores (SIS) by readm more…
Read MoreAn In-Depth Review of AAHP’s 2021 Summit
By Eric L. Foxman, Pharmacist, AAHP Secretary Having listened to the speakers at AAHP’s 2021 Summit: Implementing HPUS Guidelines for FDA Compliance, Part 2, I came away with several thoughts that will be important to manufacturers and marketers in the coming months and years. But first a huge thank you readm more…
Read MoreSuccess: Implementing HPUS Guidelines for FDA Compliance, Part 2
By Mark Land, AAHP President Co-hosted by AAHP and HPCUS on June 15, the Summit: Implementing HPUS Guidelines for FDA Compliance, Part 2 was an overwhelming success from multiple perspectives. This was the second installment of a compliance program being developed by the Homeopathic Pharmacopoeia Convention of the United States readm more…
Read MoreHomeopathy’s Path Ahead: 5 Ways We’re Moving the Needle Together
A glance at AAHP and HPCUS’ multi-year, industry-wide initiative to clarify ambiguities in homeopathic manufacturing. Homeopathy’s path forward is a collective effort between manufacturers, scientists, homeopathic practitioners, and regulators. Stemming from AAHP’s first Summit in 2019 with FDA keynote speaker Francis Godwin, the industry identified five key areas where readm more…
Read MoreThe Importance of AAHP’s 2021 Summit
Implementing HPUS Guidelines for FDA Compliance, Part 2 By Mark Land, AAHP President AAHP’s newsletter editor asked me to write an article explaining the importance of the upcoming June 15 Summit: Implementing HPUS Guidelines for FDA Compliance, Part 2. This Summit is the second installment of a compliance readm more…
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