Here are the featured FDA 483s for the week. You can obtain these at the FDAzilla 483s store here>>
The FR announced availability of the long awaited 10-page FDA draft Guidance on Data Integrity and Compliance with CGMP for comment. I include links to the MHRA guidance HERE and the draft WHO guidance HERE for comparison. The guidance is structured in a Q&A format with a total of 18 questions. This guidance focuses heavily on identifying and citing the predicate rules as they apply to electronic records and data integrity, and for this it is an excellent reference. In my opinion, though, the excessive citation of regulations detracts from the content and provides little insight into FDA’s intent and actual expectations in this area.
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by Barbara Unger, FDAzilla GMP Quality Expert
INDIA | IMPORT ALERT 66-40 and Association with Warning Letters Regarding These SitesDetention Without Physical Examination of Drugs from Firms Which Have Not Met Drug GMPs