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Pharmaceutical Technology

Pharmaceutical Technology-04-02-2003
Volume27
Issue 4

Overhauling Compliance and GMPs

Author(s):

Jill Wechsler

FDA's newly launched risk-based approach to GMP regulation spurs signficant changes in the agency's approach to inspection processes, postapproval changes, and 21 CFR Part 11 enforcement.

External Link - article-52999.pdf

Articles in this issue
Outsourcing Outlook
April 2003
Identification of Out-of-Trend Stability Results
The Relative Densisties of Pharmaceutical Powders, Blends, Dry Granulations, and Immediate-Release Tablets
Overhauling Compliance and GMPs
A Film Approach for the Stabilization of Gelatin Preparations Against Cross-Linking

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