Transcription of Questions and Answers: Improving the understanding of …
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Questions and Answers: Improving the understanding of …
30 Churchill Place Canary Wharf London E14 5EU United Kingdom An agency of the European Union Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5555 Send a question via our website European Medicines Agency, 2017. Reproduction is authorised provided the source is acknowledged. 6 June 2017 EMA/CHMP/CVMP/QWP/354895/2017 Questions and answers : Improving the understanding of NORs, PARs, DSp and normal variability of process parameters is a Normal Operating Range (NOR) and how shouldNORs be presented in the marketing authorisation dossier? Answer: NOR is not an established ICH term. The NOR describes a region around the target operating conditions that contain common operational variability (variability that can t always be controlled). A NOR can be established for several process parameters of the same process step, with the understanding that the NOR does not represent deliberate adaptation of the process, and that the NOR does not cover a parameter range that affects the quality of the process output.
Questions and answers: Improving the understanding of NORs, PARs, DSp and normal variability of process parameters . 1. What is a Normal Operating Range (NOR) and how should ... changes foreseen in PACMP for a biological/immunological medicinal product are T ype IB.
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