Transcription of Real Time Release Testing guideline
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Real Time Release Testing guideline
7 Westferry Circus Canary Wharf London E14 4HB United Kingdom Telephone +44 (0)20 7418 8400 Facsimile +44 (0)20 7418 8416 E-mail Website An agency of the European Union European Medicines Agency, 2012. Reproduction is authorised provided the source is acknowledged. 29 March 2012 EMA/CHMP/QWP/811210/2009-Rev1 Committee for Medicinal Products for Human Use (CHMP) guideline on real time Release Testing (formerly guideline on Parametric Release ) Final Draft Agreed by CHMP / CVMP Quality Working Party 26 November 2009 Adopted by CHMP for Release for consultation 17 December 2009 End of consultation (deadline for comments)
guideline is a revision of the guideline on parametric release and does not introduce new requirements. 1. Introduction (background) A medicinal product must comply with the requirements stated in the authorised specifications for release and shelf life. RTRT is a system of release that gives assurance that the product is of intended
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