Compliance

Pharmaceutical Water: Standards, Purification, and Potential Problems

November 9, 2021

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

November 8, 2021

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?

November 8, 2021

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

October 15, 2021

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

October 15, 2021

  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

October 15, 2021

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…

It’s Time to Renew FDA Drug Establishment Registrations!

October 15, 2021

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 status current in 2022, FDA…

Dilution Process Validation Is Complex and Data Driven

September 16, 2021

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 of the 1,300 substances are in commercial production. That’s a…

New FDA Report on the State of Pharmaceutical Quality Fiscal Year 2020

August 18, 2021

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An In-Depth Review of AAHP’s 2021 Summit

July 19, 2021

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…

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