According to the Code of Federal Regulations (21 CFR 211.192 Production Record Review), the failure […]
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According to the Preamble to the Good Manufacturing Practices (GMPs), the intent of a supplier […]
Analytical method validation is the process of demonstrating that an analytical procedure is suitable for […]
According to the Code of Federal Regulations (CFR), 21 CFR 211.125 strict control shall be […]
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A company recently received the following observation: ….. The Quality Unit is not involved in […]
GMP Trends has seen multiple observations related to cleaning validation cited by the U.S. FDA […]
Do you have sufficient information in your complaint investigations? Do your investigation reports include conclusions […]
Management Review is all about reviewing the available data to confirm that adequate resources are […]