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…
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…
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…
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…
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…
Anatomy of a Compliant Drug Facts Panel
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
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?
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.
FDA’s Compendial Operations and Standards Branch (COSB)
FDA’s Compendial Operations and Standards Branch (COSB) a branch within FDA’s Office of Pharmaceutical Quality (OPQ) is responsible for the management of agency staff selection and the maintenance of participation in standards development activities…
Homeopathy Mentioned Twice in FDA 2021 Budget Is Telling of Issues to Come
By Mark Land, AAHP President | In February, the White House released the President’s Fiscal Year 2021 Budget. Correspondingly, each agency publishes a detailed budget justification…
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