PRODUCTION
![What is ICH in pharmaceutical industry?]()
QC
Sathyanarayana M.Sc.
March 01, 2023
![What are GMP principles?]()
QC
Sathyanarayana M.Sc.
February 28, 2023
![Why is GMP important in pharmaceutical industry?]()
QC
Sathyanarayana M.Sc.
February 24, 2023
![What specific CGMP regulations might be useful to manufacturers of topical antiseptic drug products?]()
USFDA
Sathyanarayana M.Sc.
November 14, 2022
![Does CGMP regulations require three successful process validation batches before a new API or a finished drug product is released for distribution?]()
USFDA
Sathyanarayana M.Sc.
November 04, 2022
![FDA Process Validation Guidance 2011: General Principles and Practices]()
USFDA
Sathyanarayana M.Sc.
November 04, 2022
![Should acceptance criteria for residues be defined for dedicated equipment?]()
QC
Sathyanarayana M.Sc.
October 31, 2022
![Does ICH Q7 expect that the quality unit performs API release testing?]()
QC
Sathyanarayana M.Sc.
October 21, 2022
![Some products, such as transdermal patches, are made using manufacturing processes with higher in-process material reject rates than for other products and processes. Is this okay?]()
USFDA
Sathyanarayana M.Sc.
October 10, 2022
![Can containers, closures, and packaging materials be sampled for receipt examination in the warehouse?]()
USFDA
Sathyanarayana M.Sc.
September 09, 2022
![Do CGMPs require a firm to retain equipment status identification labels with batch record or logs?]()
USFDA
Sathyanarayana M.Sc.
September 05, 2022
![Why does the FDA inspect and what does an FDA inspector do?]()
USFDA
Sathyanarayana M.Sc.
July 22, 2022
![If the FDA calls to inspect your facility tomorrow? in Telugu]()
QC
Sathyanarayana M.Sc.
July 09, 2022
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September 05, 2022
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