Your Reputation Precedes You

By Mark Land, AAHP President | Brian Westerlind, Editor of the Network News, writes in his article on warning letters – “Each day AAHP works to promote excellence in the practice of homeopathic manufacturing. While achieving true excellence is a lofty goal, it begins with a few simple principles you can start to implement today.”

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4 Simple Ways to Keep Your Homeopathic Manufacturing Process Safe and Effective

Each day AAHP works to promote excellence in the practice of homeopathic manufacturing. While achieving true excellence is a lofty goal, it begins with a few simple principles you can start to implement today.

We’ve reviewed recent Warning Letters from the U.S. FDA—which highlight some of the most common missteps and shortcomings—and have put together these four basic ground rules that can help any homeopathic manufacturer or marketer strive toward excellence.

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Poison Control Center Statistics on Homeopathy

What’s Your Company’s Safety Statistics?   When FDA announced its public hearing on homeopathy, the agency cited 10,311 reported poison exposure cases related to “homeopathic agents” in the 2012 American Association of Poison Control Centers Annual Report. This article will introduce a new program by the National Capital Poison Center readm more…

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What is the HPUS and Who Creates It?

By Eric L. Foxman, R.Ph., senior scientist, HPCUS Homeopathic pharmacopoeias have been published continually since the 1840s. The Homeopathic Pharmacopoeia of the United States (HPUS) has been in continuous publication for over 120 years — since 1897. It became officially recognized under the U.S. Food Drug and Cosmetic Act in readm more…

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FDA Warning Letter Lessons?

By Eric L. Foxman, R.PH., AAHP Secretary Of all the Warning Letters issued by the FDA, very few go to homeopathic manufacturers or marketers. That’s good. On the other hand, the few that are addressed to members of our industry reveal a wide divide between what is required by 21 readm more…

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Homeopathic Process Validation for Beginners

Consistent, effective, high-quality homeopathic products. That’s what our consumers want in each and every dose. Yet quality doesn’t happen by accident. Manufacturers must create it through process validation. Each manufacturer must ask themselves: Do I have scientific evidence that my (manufacturing) process is capable of reliably delivering quality product?   readm more…

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New Regulatory Requirement; Know What to You Need to Comply

“Since the beginning of September 2020, CGMP regulations now require all manufacturers of drug products to detect and quantify any methanol present in each lot of alcohol they receive. Assurance of this has most likely been made a high priority for FDA field personnel.”     By Eric Foxman, AAHP readm more…

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New FDA Report on the State of Pharmaceutical Quality

By Mark Land, AAHP President A quality drug is consistently safe, effective, and free of contamination or defects. Patients and consumers expect quality drugs with every dose they take. The homeopathic industry monitors the quality of its products, and so too does the U.S. Food and Drug Administration (FDA). Specifically, readm more…

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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 readm more…

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How to Stop Bad Inspections: It Starts with Staff

By Mark Land, AAHP President   At AAHP, we firmly believe that compliance with quality and safety regulations is crucial for all homeopathic manufacturers. To educate our community, we’ve published content on preparing for the different types of FDA inspections, and last month I offered more insight into quality systems, readm more…

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