Regulatory Pathways for Parametric Release
Posted on September 2, 2015
By: Marla Stevens-Riley, Ph.D.
Senior Microbiologist
Division of Regulations, Guidance, and Standards
FDA/OMPT/CDER/OPQ/OPPQ
Parametric Release and Pharmaceutical Manufacturing Manufacturing flexibility, better process understanding, and optimal manufacturing control are desirable goals for the pharmaceutical industry. There are a variety of ways in which firms can achieve these goals, and the development of a parametric ...
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Related Topics and Keywords
CGMP regulations for finished pharmaceuticals, Code of Federal Regulations (CFR) 21 CFR 211.165(a) and 211.167(a), critical process controls, manufacturing flexibility, Marla Stevens-Riley, optimal manufacturing control, Parametric Release, parametric release program, Pharmaceutical Manufacturing, process understanding, Regulatory Pathways for Parametric Release, sterility, sterilization process
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