Thursday, January 10, 2008

Proposed Revision in 21 CFR Part 211

The Food and Drug Administration (FDA) is amending certain regulations as the first phase of an incremental approach to modifying the current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. On Dec 4, 2007, the FDA published changes to FDA's drug GMP regulation (Part 211). This is the first step of a phased approach to modernize GMPs. The revised text will be effective from April 17, 2008, if no significant comments are received before February 19, 2008.

Based on the CGMP Working Group’s analysis, FDA decided to take an incremental approach to modifying parts 210 and 211. This is the first increment of modifications to parts 210 and 211

The major highlights for this revision being the following:

A. Plumbing
B. Aseptic Processing
C. Asbestos Filters
D. Verification by second individual

For details summary, read here:

No comments:

Post a Comment