Members Heads-Up on Two New Hot FDA Announcements
By Mark Land, AAHP President Recently members received a special e-blast alerting them of two important FDA announcements. While members can read more on a password protected webpage as a member benefit, it is worth briefly summarizing the announcements for all our readers to keep our industry compliant. First, FDA distributed a public service announcement…
Pharmaceutical Water: Standards, Purification, and Potential Problems
By Tim Clarot, Industry Consultant Water is vitally important for all living things and is found everywhere on earth-from the polar ice caps to steamy geysers. Wherever water flows, you will also find living organisms. Water-borne microorganisms are ubiquitous and varied in their ability to survive and grow under different conditions. Pharmaceutical manufacturing, like…
CMO Selection and Auditing for the Homeopathic Industry
Supply Chain Management for Homeopathy, Part 2 of 4 By Tim Clarot, Industry Consultant In part one, we introduced the concept of the supply chain as part of a CGMP-compliant pharmaceutical manufacturing and distribution system. As noted, many product owners rely, in whole or in part, on a contract manufacturing organization (CMO). Accordingly, selection…
Are You Certain Your Homeopathic Attenuation Labeling is Correct?
By Eric Foxman, Pharm., AAHP Secretary FDA noted some concerns that homeopathic drug products may not always be labeled to clearly indicate whether homeopathic attenuations have been made using the Hahnemannian or the Korsakovian method. These remarks were made Richard Lostritto, PhD, Associate Director for Science, Office of Policy for Pharmaceutical Quality at FDA’s…
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 regulated products like pharmaceuticals, where…
FDA’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 inspections of homeopathic manufacturers in…
Introducing 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 from George Bernstein, PhD., whose…
An In-Depth Review of AAHP’s 2021 Summit
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 to the presenters and the behind-the-scenes organizers of the event. As an…
Success: Implementing HPUS Guidelines for FDA Compliance, Part 2
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 (HPCUS) and presented by AAHP. This program aims to develop…
Sourcing Homeopathic Active Pharmaceutical Ingredients: Controls, Arrangements
By Mark Land, AAHP President In light of recent warning letters to homeopathic manufacturers, I have received several questions regarding procurement of homeopathic active pharmaceutical ingredients (API). Usually the conversations begin something like this: since I can’t test for the active ingredient how do I comply with FDA’s expectations for control of components? Code of…