Compliance
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…
Read MoreSourcing 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…
Read MoreHow 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…
Read MoreAnatomy 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
Read MoreThe 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.
Read MoreIs 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.
Read MoreFDA’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…
Read MoreHomeopathy 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…
Read MoreIn Times of Public Health Crisis, Vulnerable Consumers Look to Us for Sound Advice
By Mark Land, AAHP President | I have experienced many infectious disease crises thus far in my lifetime and each one was characterized by fear and uncertainty…
Read More3 Homeopathic Compliance Hot Spots to Watch
All drug products, homeopathic and allopathic alike, must be safe and effective. That means they have to be manufactured correctly, containing only the ingredients and potencies they claim to have. In short, all drugs must comply with Current Good Manufacturing Practice (CGMP). It is not only FDA’s responsibility to ensure these medications fulfill the CGMP requirements of safety, identity, strength, quality, and purity—it’s the industry’s responsibility, too.
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