Sunday, November 9, 2008

Recent Changes in GMP Rules

The changes in the GMP rules by the FDA after due consultation from Industry are finally announced. Effective from 8th September, primarily these changes focus on - Plumbing, Aseptic processing, Asbestos filters and Verification by second individual etc.
While a summary of the proposal was already published in details sometimes back in April (click here to read), Krishna Rao has also done a great favour in reviewing and preparing a comparative analysis of these changes in CFR 211. The review by Krishna is published in 'The Pharma Web Journal' and can be read or downloaded in acrobat.

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