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,…
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…
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…
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…
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…
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…
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.…
Dilution Process Validation Is Complex and Data Driven
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…
New FDA Report on the State of Pharmaceutical Quality Fiscal Year 2020
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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…
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