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 readm more…

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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 readm more…

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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 readm more…

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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…

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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 readm more…

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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 readm more…

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It’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…

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Dilution 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…

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New 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…

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An 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…

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