Overhauling Compliance and GMPs

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

about 23 years ago

Article

Outsourcing Outlook

about 23 years ago

Article

April 2003

about 23 years ago

Article

Identification of Out-of-Trend Stability Results

about 23 years ago

Article

The Relative Densisties of Pharmaceutical Powders, Blends, Dry Granulations, and Immediate-Release Tablets

about 23 years ago

Article

A Film Approach for the Stabilization of Gelatin Preparations Against Cross-Linking

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