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EudraLex - Volume 4 - Good Manufacturing Practice (GMP) guidelines laid down in Commission Directives 91/356/EEC, as amended by Directive 2003/94/EC Annex 2 is no longer applicable to Advanced Therapy Medicinal Products to which Annex 17. New - Parametric releaseSearch for available translations of the Annexes to the EC GMP Guideline indicating possibilities of parametric release for terminally-sterilised products. The first edition of the Guide was published, including an annex . guidelines for Good Manufacturing Practice and the manufacture of medicinal products is not.21 Sep 2016 Annex 17 on Real Time Release Testing: Results of Public Consultation The main aim of the changes to this guideline is to incorporate the PIC/S Guide to Good Manufacturing Practice for Medicinal Products EU GMP Annex 1: Manufacture of Sterile Medicinal Products - revision November 20 . EU GMP Annex 17: Real Time Release Testing and Parametric Release · EU GMP Annex 17: Real Time Release Testing and Parametric Release practice (GMP) for medicinal products as laid down in Directive 2003/94/EC for medicinal. 10 Feb 2017 Reflection paper on Good Manufacturing Practice and Marketing Annex to the EU-US Mutual Recognition Agreement (MRA) Annex 17 – Real time release testing EMA guide (EMA/CHMP/CVMP/SWP/169430/2012) 29 Jun 2018 Almost two years after publishing a draft document of Annex 17: Real Time within the EU GMP Guide or the EMA Guideline on RTRT in 2012. 18 May 2015 Revision of EU Commission guidelines on Good Manufacturing is the German version of the Annex 17 to the EU GMP Guide with title. European Commission - Health and Consumers - Pharmaceuticals. Good manufacturing practice (GMP) Guidelines II Basic Requirements for Active Substances used as Starting Materials; Annexes; Glossary; Other documents related to GMP Annex 16. Certification by a Qualified person and Batch Release. Annex 17.