New PIC/S Document on GMP for APIs

Nowadays, the production and distribution of APIs is almost only based on worldwide interconnection. Intermediate steps for the manufacture of APIs e.g. micronisation, granulation, coating, sterilisation, repackaging, etc. often take place in different places. The complete traceability of this chain back to the original manufacturer of the starting materials is often a real challenge for the drug manufacturer who is responsible for the quality of the API. In the context of numerous single processing operations, is not always obvious who is considered as the original API manufacturer.

In May 2010 a team of experts for pharmaceutical APIs of the Pharmaceutical Inspection Co-Operation Scheme (PIC/S) met in Dublin and agreed on a Questions & Answers document aiming at explaining issues on the integrity of the API supply chain. The document is dated 24 March 2011 and is intended to provide guidance to GMP inspectors from supervisory authorities. Of course the questions asked are interesting for both the pharmaceutical and the API industry. The following questions taken from the document are examples relating to the distribution of APIs and repackaging/relabelling procedures:

  • How does the finished product manufacturer assure his knowledge about and the integrity of the whole API supply chain? 
  • What kind of information is indispensable about transport conditions?  Does the shipping process need to be validated?
  • Which aspects should be focused on during inspections of repackagers/relabellers?
  • The PIC/S GMP guidance contains no definition for relabelling/repackaging. What is the PIC/S experts for pharmaceutical APIs view on that question?
  • Do stability studies need to be performed on repackaged APIs?

Altogether, the Q&A document provides essential and useful clarification in regard to securing quality of the production and distribution of APIs.

For further information please see this important document.

Dr Gerhard Becker
CONCEPT HEIDELBERG (a service provider entrusted by the ECA Foundation)

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