Topics: Questions & Answers - USNA Parents
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?
Do the CGMP regulations permit the destruction of an internal quality assurance audit report once the corrective action has been completed?
How do the Part 11 regulations and predicate rule requirements (in 21 CFR Part 211) apply to the electronic records created by computerized laboratory systems and the associated printed chromatograms that are used in drug manufacturing and testing?