Resources (1-2 of 2)

1. Pharmaceutical Development

   out of 5 stars 

   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)

   out of 5 stars 

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