EU Annex 17 – Real Time Release and Parametric Release

Annex 17, Real Time Release Testing and Parametric Release, published by the European Commission, outlines the requirements for application of Real Time Release Testing (RTRT) and parametric release as an alternative to routine end-product testing of active substances and/or finished products. This revision to Annex 17, incorporates parametric release, process analytical testing (PAT), quality by design (QbD), and quality risk management (QRM) principles. This revision also takes into account changes to other sections of the EudraLex, Volume 4, Part I, Chapter 1, Annex 1 and 15, ICH Q8, Q9, Q10 and Q11, QWP Guideline on Real Time Release Testing, and changes in manufacturing and analytical technology. The deadline for implementation of Annex 17, version 1, is December 26, 2018.

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