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Showing posts with the label USFDAShow all
US FDA issues warning letter to Glenmark Pharma Goa unit

US FDA issues warning letter to Glenmark Pharma Goa unit November 24, 2022

FDA 21 CFR Part 11 Guidelines for Pharmaceuticals

FDA 21 CFR Part 11 Guidelines for Pharmaceuticals November 18, 2022

What specific CGMP regulations might be useful to manufacturers of topical antiseptic drug products?

What specific CGMP regulations might be useful to manufacturers of topical antiseptic drug products? 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?

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

FDA Process Validation Guidance 2011: General Principles and Practices

FDA Process Validation Guidance 2011: General Principles and Practices November 04, 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?

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? October 10, 2022

Can containers, closures, and packaging materials be sampled for receipt examination in the warehouse?

Can containers, closures, and packaging materials be sampled for receipt examination in the warehouse? September 09, 2022

Do CGMPs require a firm to retain equipment status identification labels with batch record or logs?

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

What are the different styles of hearing aids?

What are the different styles of hearing aids? August 17, 2022

What are hearing aids and how do they work?

What are hearing aids and how do they work? August 17, 2022

FDA issued warning letters to 3 companies for selling unapproved new drugs

FDA issued warning letters to 3 companies for selling unapproved new drugs August 10, 2022

How many titles are there in the FDA CFR (Code of Federal Regulations)?

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

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