Common use of GMP Guidelines Clause in Contracts

GMP Guidelines. The premises, equipment and systems used to manufacture and release the Product must be in compliance with all applicable GMP requirements for APIs, including the principles detailed in the US Code of Federal Regulations, Parts 11, 210, 211, and ICH Q7 GMP Guide for APIs, as accepted and implemented by the national and international regulations of the European Community, the United States of America, Japan and the member slates of the PIC scheme.

GMP Guidelines. The premises, equipment and systems used to manufacture and release the Product must be in compliance with all applicable GMP requirements for APIsrequirements, including the principles detailed in the US Code of Federal Regulations, Parts 11, 210, 211, and ICH Q7 GMP Guide for APIs, as accepted and implemented by the national and international regulations of the European Community, the United States of America, Japan and the member slates states of the PIC scheme.