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New Concept Paper on Annex 17 of the EU GMP Guide


The European Medicines Agency EMA has published a draft concept paper on the revision of Annex 17 (Parametric Release). "The GMP/GDP Inspectors Working Group recommends that the current version of Annex 17 on Parametric Release is revised to reflect changes in regulatory and manufacturing environments. The new guideline should clarify how manufacturers can take advantage of new possibilities deriving from the application of an enhanced process understanding by using innovative tools as described in the ICH Q8, Q9 Q10 and Q11 guidelines. The revision of Annex 17 should also take into account related changes in other GMP chapters and Annexes as well as in other regulatory documents."

Published in 2002, the current annex 17 on Parametric Release was issued before the relevant ICH concepts have been created. Now, with ICH Q11 on Development and Manufacture of Drug Substances and ICH Q8 on Pharmaceutical Development, opportunities have been created to better use the knowledge gained in the development of a product in applications and the manufacturing process. Besides that, ICH Q9 offers a systematic approach to Quality Risk Management, and Q10 describes a modern quality system.

It is the intention that the revised guideline will clarify to what extent Q8, Q9 Q10 and Q11 should be followed in order to implement Real Time Release Testing (RTRT). It should also detail how to design a system of release that provides assurance that the product or active substance is of the intended quality.

The consultation end date is 28/02/2013. Comments should be submitted to

Source: Draft Concept paper on revision of Annex 17 of the GMP guide (EMA/INS/GMP/705479/2012)