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.
