Using a Systematic Approach to Select Critical Process Parameters

Little, Thomas A.
November 2012
Pharmaceutical Technology;Nov2012 Supplement Analytical and Bioanalytical testing, pS44
Trade Publication
The article discusses critical process parameters (CPPs) which are important for drug development and process validation in manufacturing unit operation. It suggests determining critical quality attributes (CQAs) for drug products as it is important for drug product quality and clinical trials. It also suggests considering quality risk management for CPP. It further suggests considering ease of use, safety and risk factors for CPP.


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