USFDA
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USFDA
Sathyanarayana M.Sc.
November 14, 2022
What specific CGMP regulations might be useful to manufacturers of topical antiseptic drug products?

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USFDA
Sathyanarayana M.Sc.
November 04, 2022
Does CGMP regulations require three successful process validation batches before a new API or a finished drug product is released for distribution?

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USFDA
Sathyanarayana M.Sc.
November 04, 2022
FDA Process Validation Guidance 2011: General Principles and Practices


USFDA
Sathyanarayana M.Sc.
September 09, 2022
Can containers, closures, and packaging materials be sampled for receipt examination in the warehouse?


USFDA
Sathyanarayana M.Sc.
September 05, 2022
Do CGMPs require a firm to retain equipment status identification labels with batch record or logs?

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USFDA
Sathyanarayana M.Sc.
August 10, 2022
FDA issued warning letters to 3 companies for selling unapproved new drugs


USFDA
Sathyanarayana M.Sc.
August 07, 2022
How many titles are there in the FDA CFR (Code of Federal Regulations)?
