QC
USFDA
What specific CGMP regulations might be useful to manufacturers of topical antiseptic drug products?
Sathyanarayana M.Sc.
November 14, 2022
USFDA
Does CGMP regulations require three successful process validation batches before a new API or a finished drug product is released for distribution?
Sathyanarayana M.Sc.
November 04, 2022
USFDA
FDA Process Validation Guidance 2011: General Principles and Practices
Sathyanarayana M.Sc.
November 04, 2022
QC
Should acceptance criteria for residues be defined for dedicated equipment?
Sathyanarayana M.Sc.
October 31, 2022
QC
Does ICH Q7 expect that the quality unit performs API release testing?
Sathyanarayana M.Sc.
October 21, 2022
USFDA
Can containers, closures, and packaging materials be sampled for receipt examination in the warehouse?
Sathyanarayana M.Sc.
September 09, 2022
USFDA
Why does the FDA inspect and what does an FDA inspector do?
Sathyanarayana M.Sc.
July 22, 2022