Initial Results Released on Three-Way GMP Inspection Pilot

Information on good manufacturing practice (GMP) inspections at more than 1,000 active pharmaceutical ingredient (API) manufacturing sites has been entered in a master list compiled by the FDA, the EU’s European Medicines Agency, the European Directorate for the Quality of Medicines and Healthcare, and Australia’s Therapeutic Goods Administration (TGA). According to an interim report on the 18-month joint inspection pilot program, the list contains 499 sites submitted by the EU, 352 from the FDA and 195 from the TGA for a total of 1,046.
International Pharmaceutical Regulatory Monitor