Executive Summary

The European Commission is consulting the public on Part III of the EU GMPs, which describes how manufacturers should prepare site master files. The deadline for public comment is March 31. The site master file concept has been developed by the Pharmaceutical Inspection Cooperation Scheme and has become a standard expectation of EU authorities. Following a recent revision of the explanatory notes by PIC/S, it has been proposed that the status of the site master file is more formally linked to the EU regulatory framework. The site master file should contain specific information about the quality management policies and activities of the company, the production site and the quality control of pharmaceutical manufacturing operations carried out at the named site and any closely integrated operations at adjacent and nearby buildings. When submitted to a regulatory authority, the site master file "should provide clear information on the manufacturer's GMP-related activities that can be useful in general supervision and in the efficient planning and undertaking of GMP inspections.