EU Commission issues two final Guidelines: GMP for Excipients and GDP for APIs

After nearly two years of consultation, the European Commission has published two important and long-awaited guidelines in the official journal of the European Union, edition 21st March 2015: 

  • The "guidelines on the principles of good distribution practice for active substances of medicinal products for human use" and 
  • The "formalised risk assessment for ascertaining the appropriate good manufacturing practice for excipients of medicinal products for human use"

Both guidelines were already published as draft documents on 6th February 2013 on the News page of the European Commission (Pharmaceutical Archives - 2012), and they were open for comments until 30th April 2013.

Both guidelines are considerably more detailed in their present form and contain more stringent requirements than the respective drafts. For instance, as part of the risk assessment for pharmaceutical excipients the supply chain including cold chain management, the stability of the excipient and the suitability of the packaging have to be evaluated.

The requirements with regard to the quality assurance system of distributors for APIs are also much more detailed and demand the tracking and documentation of deviations and a CAPA system.

The guidelines on GDP for APIs are also relevant for the national authorities as they are a further specification of the provisions laid down in part II of the EC GMP Guide.

A more detailed analysis of the two documents will be issued in the next newsletters.

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