Resources (1-2 of 2)

1. Pharmaceutical Development

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   09 Jun 2023

   Guideline lays the foundation for developing pharmaceutical manufacturing processes, intoducing concepts such as QbD and PAT as key components of a successful pharmaceutical manufacturing operation.

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

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   09 Jun 2023

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