Does your company experience a gap between 21 CFR cGMP requirements and the pragmatic realities of implementation for homeopathic drug products? AAHP, in partnership with the Homeopathic Pharmacopoeia Convention of the United States (HPCUS), has identified five technical gaps that are challenges for both industry and FDA inspectors. In a continuation of this industrywide, multi-year effort, the 2021 Summit will present:
• Concept Paper: Process Validation for Preparation of Hahnemannian Liquids
• White Paper: Control of Active Pharmaceutical Ingredients
• Views on these pharmaceutical quality issues and necessary compliance considerations by Richard Lostritto, PhD, Associate Director for Science, Office of Policy for Pharmaceutical Quality at FDA’s CDER.