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Tags: Process Validation

Resources (1-3 of 3)

  1. Continuous Manufacturing in the Pharmaceutical Industry: Enhancing Drug Production

    23 Jul 2024 | Contributor(s):: Timmerman, Siebe

    A significant shift towards continuous manufacturing (CM) is currently underway in the pharmaceutical industry. Unlike the more commonly used batch processing, CM operates continuously. This method potentially offers increased efficiency, agility, and flexibility in the manufacturing of drug...

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

    Document | 28 Mar 2024 | 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

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

    Document | 09 Jun 2023

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