Document (1-2 of 2)

1. The Process Analytical Technology Initiative: PAT and the Pharmacopeias

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   | Contributor(s):: Ajaz S. Hussain

   The PAT Initiative A part of the Pharmaceutical Quality for the 21st Century Initiative  PAT and the USP Opportunities for the USP to support the PAT Framework

2. Development and Manufacture of Drug Substances (Chemical Entities and Biotechnological/Biological Entities)

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   Guideline establishes reuqirements for the synthesis/production of API in primary pharmaceutical manufacturing.