An Intellectual approach of PIC/S Guide to Good Manufacturing Practice for Medicinal Products

Abstract

In a retrospective approach on the link between PIC/S guide to GMP is to meet the quality and standards in manufacturing the Pharmaceutical products. The Pharmaceutical Inspection Co-operation Scheme (PIC/S) is a scheme promising to informal co-operative arrangement between Regulatory Authorities in the field of Good Manufacturing Practice (GMP) of medicinal products for human. It is open to any Authority having a comparable GMP inspection system. The main instrument for harmonisation has been the PIC/S GMP Guide. The PIC/S provide an active and constructive cooperation in the field of GMP and related areas. The purpose of PIC/S is to facilitate, networking between participating authorities, maintenance of mutual confidence, exchange of information and experience, mutual training of GMP inspectors.