Compliance

What is the HPUS and Who Creates It?

December 20, 2020

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 more than 125 years – since 1897. It became officially recognized under the U.S. Food Drug and Cosmetic Act in 1938 and was published…

FDA Warning Letter Lessons?

November 21, 2020

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

October 25, 2020

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

September 27, 2020

“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

September 22, 2020

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…

Sourcing Homeopathic Active Pharmaceutical Ingredients: Controls, Arrangements

August 4, 2020

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 control of components? Code of…

How to Stop Bad Inspections: It Starts with Staff

June 23, 2020

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…

Anatomy of a Compliant Drug Facts Panel

June 17, 2020

In my May 2020 article entitled The Anatomy of a Compliant Homeopathic Label, I covered The importance of considering the intended use statements that will be placed on the label

The Anatomy of a Compliant Homeopathic Label

May 20, 2020

By Eric L. Foxman, R.Ph., AAHP Secretary | Before examining the details of a compliant homeopathic drug product label, it is important to consider labeling in relation to the FDA Draft Enforcement Guidance.

Is the Homeopathic Industry Underinvesting in Quality Systems?

May 20, 2020

By Mark Land, AAHP President | I’ve been pondering this question for some time, ever since preparing for my presentation on FDA enforcement trends during AAHP’s Quality and Safety Summit last June in Baltimore.

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