The documents to be submitted as proof of GMP compliance are listed in the Guidance on GMP Compliance for Foreign Manufacturers.

Required GMP documentation for active substances:

GMP documentation is required for the manufacturer performing the final manufacturing step.

For manufacturers of intermediates and QC testing labs, proof is required only if the manufacturer performing the final manufacturing step cannot ensure a clear chain of responsibility (see Chapter 5 of the Guidance on GMP Compliance for Foreign Manufacturers: It is the responsibility of the RP to ensure that any intermediate steps outsourced to third parties (including QC) have also been carried out in compliance with GMP. The RP must, for its part, ensure that the active substance manufacturer has fulfilled its responsibilities. If no clear chain of responsibility exists, the RP declaration must be submitted for all sub-manufacturers.).

Required GMP documentation for finished products:

GMP documentation is required for the manufacturer, QC testing laboratories, packager (=manufacturer), and technical release.

As a rule, no GMP documentation is required for manufacturers of intermediates (see Chapter 5 of the Guidance on GMP Compliance of Foreign Manufacturers).

Note: For ATMPs, GMP conformity must be documented additionally for intermediate manufacturers and quality control sites of the drug substance and drug product. Moreover, GMP conformity is to be documented for critical excipients.

GMP Documentation Requirements for Manufacturers