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Article: PAT rollout to have technical guidance, possibly derived from ASTM, CDRH. (Process analytical technology).
- Article from:
- Validation Times
- Article date:
- January 1, 2003
- Author:
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SCOTTSDALE, AZ -- Once FDA gets through with implementing some "immediate steps" under its "Pharmaceutical GMPs for the 21 Century" initiative (see below), the agency will issue an overall guidance to industry on how to implement process analytical technology (PAT) and then either one or several technical guidance documents, officials said here Jan. 21.
Ajaz Hussain, Ph.D., deputy director of the Center for Drugs Office of Pharmaceutical Science, and leader of the PAT initiative, told the International Forum for Process Analytical Chemistry (IFPAC) that FDA also does not want to "reinvent the wheel" with guidance.
Hence, he said, CDER will borrow from ...