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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 on Real Time Release Testing (formerly Guideline on Parametric Release) Final . Draft Agreed by CHMP / CVMP Quality Working Party . ... A specification is also necessary for stability studies, in order to establish a product shelf-life as well as for Official Medicines Control Laboratory (OMCL) controls. The application for RTRT should be

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