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 CFR parts 210 & 211,…
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? It’s important to note that…
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 Secretary Francis Godwin, Director…
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, it is the Office of…
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, one of the most cited…
How to Submit Monographs to the HPUS
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AAHP 2019: Reawakening the Regulatory and Retail Dialog
By Mark Land, AAHP President This year marks the fifth year in a cycle of regulatory review of homeopathic drug product labeling, safety, and quality. AAHP has been there for the industry as an advocate and representative over the entire duration. In 2019 AAHP provided direction and regulatory thought-leadership within the homeopathic community, met with…
4 Types of FDA Inspections & How to Prepare
Risk. It’s a hot word in the homeopathic industry right now. Even before the FDA issued its draft guidance, the agency used a risk-based approach to site inspections. With the 2012 Safety and Innovation Act, the agency nixed a set inspection calendar and began visiting manufacturers “in accordance with a risk-based schedule” that considers “known…
Little-Known Facts About 3 Unique Starting Materials
By Mary Beth Watkins and Eric Foxman The array of substances used for homeopathic drug products is wide and varied. Many homeopathic starting materials also have uses outside of our industry and might be familiar by their common English names. We’ve reformatted “Drug Facts” panels to give you several little-known facts about Formica rufa,…
Clearing the Air: Consider Slack-Fill
By Mark Land, AAHP President Although the term might not be familiar, you may have been fooled by “slack-fill” as a consumer of many types of products at one time in your past. It’s the difference between the actual capacity of a container and the volume of the product inside. To prevent consumers being…