ICH guideline Q7

As an ICH guideline, Q7 takes a primary position. ICH guideline Q7 relates to the whole range of Good Manufacturing Practice (GMP) for a human drug’s Active Pharmaceutical Ingredient (API) covering the US, the EU and Japan. Originally called the ICH Q7A; these guidelines were issued in November 2000 by the International Conference on Harmonization (ICH).

Covers a range of topics

Being an important ICH guideline,Q7 covers a whole range of topics. Quality management, personnel qualifications and materials management are some of these. ICH guideline Q7 also covers the following:

  • Documentations and records;
  • Materials management;
  • Production and in-process controls;
  • Packaging and identification labeling of APIs and intermediates;
  • Storage and distribution;
  • Laboratory controls;
  • Validations;
  • Change controls;
  • Rejection and re-use of materials;
  • Complaints and recalls;
  • Contract manufacturers (including laboratories);
  • Agents, brokers, traders, distributors, repackers, and relabellers;
  • Specific guidance for APIs manufactured by cell culture/fermentation;
  • APIs for use in clinical trials

Forthcoming Q and A

In a concept paper published in October 2012; the ICH sought to have a Q and A document for ICH guideline Q7. These have been considered necessary in the wake of development of new quality concepts. It is being felt in Quality circles that new guidelines in respect of ICH guideline Q7 need to be issued or existing ones need to be updated to “harmonize expectations during inspections”.

One of the sections for which the ICH will consider Q and A documents relates to ICH guideline Q7.  The concept paper states that “…it has become apparent that certain individual implementation approaches are leading to non-harmonized interpretation and new expectations which go beyond the intention of ICH Q7.” These will be taken up at conferences at various venues during May/June 2013.




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