TITLE

Using a Systematic Approach to Select Critical Process Parameters

AUTHOR(S)
Little, Thomas A.
PUB. DATE
November 2012
SOURCE
Pharmaceutical Technology;Nov2012 Supplement Analytical and Bioanalytical testing, pS44
SOURCE TYPE
Trade Publication
DOC. TYPE
Article
ABSTRACT
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.
ACCESSION #
83474555

 

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