Regulatory Roundup: PQRI and FDA present Process Drift Workshop, and More.

The Product Quality Research Institute (PQRI) and the US Food and Drug Administration are hosting a joint workshop called Process Drift: Detection, Measurement, and Control in the Manufacture of Pharmaceuticals, in December in Bethesda, Maryland. The workshop will address: a life-cycle approach to monitoring manufacturing performance that assures prompt detection and correction of meaningful variation; technological and management system approaches to better control process variation and mitigate product variability; and the impact of process drift on product performance, safety, and efficacy. Several industry and regulatory leaders are on the roster.

The Medicines Quality Monitoring surveillance program, a colloboration of the US Pharmacopeia (USP), Ghana Food and Drugs Board (FDB), and US Agency for International Development (USAID), uncovered substandard and counterfeit versions of 13 antimalarial medicines in multiple locations across Ghana. The program was established in 2008 and is implemented by USP’s Promoting the Quality of Medicines (PQM) initiative. According to a USP press release, the program uncovered a counterfeit version of Novartis’ Coartem, a widely used antimalarial, in 2009. The discovery of the counterfeits resulted in a nationwide recall of all 13 drugs, including publicizing the names of the outlets where they were found.  

This week, the steering committee and expert working groups of the International Conference on Harmonization have been meeting in Japan to discuss current harmonization efforts, including the implementation of the quality guidelines and the draft of the Q11 guideline on the Development and Manufacture of Drug Substance. Post-meeting summaries are expected soon.