News about GMP/cGMP


EC: Final Version of Annex 17 RTRT and Parametric Release

Almost two years after publishing a draft document of Annex 17: Real Time Release Testing the European Commission has now published the final version newly entitled Annex 17: Real Time Release Testing and Parametric Release. The eight-page document will come into operation on 26 December 2018 and will finally replace the preceding version of the year 2002.

Since then, there have been significant changes in GMP consequent to the adoption of the ICH Q8-11 guidelines and revisions within the EU GMP Guide or the EMA Guideline on RTRT in 2012. Moreover, advances in the application of process analytical technology (PAT), quality by design (QbD) and quality risk management (QRM) principles to pharmaceutical development and manufacturing have shown that appropriate combination of process controls together with timely monitoring and verification of pre-established material attributes provide greater assurance of product quality than end-product testing alone.

We will report on the document in more detail in an upcoming LOGFILE.


EC: Eudralex Volume 4, Annex 17