PIC/S Guide to Good Manufacturing Practice for Medicinal Products - Part I

Part I of the PIC/S GMP Guide (PE 009): basic requirements for medicinal products, covering the pharmaceutical quality system, personnel, premises and equipment, documentation, production, quality control, outsourced activities, complaints and recalls, and self-inspection. Harmonised with EudraLex Volume 4 Part I.

Organizations:

Pharmaceutical Inspection Co-operation Scheme (PIC/S)