QA
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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

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QC
Sathyanarayana M.Sc.
October 31, 2022
Should acceptance criteria for residues be defined for dedicated equipment?

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QC
Sathyanarayana M.Sc.
October 21, 2022
Does ICH Q7 expect that the quality unit performs API release testing?


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?


USFDA
Sathyanarayana M.Sc.
July 22, 2022
Why does the FDA inspect and what does an FDA inspector do?
