1. Know thy process
- Author
-
Thayer, Ann M.
- Subjects
United States. Food and Drug Administration -- Management ,Computerized instruments -- Evaluation ,Pharmaceutical industry -- Management ,Company business management ,Chemicals, plastics and rubber industries ,Engineering and manufacturing industries - Abstract
The guidance document supporting process analytical technology (PAT) released by the US Food & Drug Administration department is part of a broader initiative on current Good Manufacturing Practices to be followed by the pharmaceutical industry. The agency says that the goal of the PAT, which involves on-line, in-line, or at-line measurements at critical processing points for feedback and quality control, is to design and develop processes that ensure quality products.
- Published
- 2005