According to the Code of Federal Regulations (21 CFR 820.22 Quality Audit), Each manufacturer shall […]
According to the Code of Federal Regulations (21 CFR 820.20 Management Responsibility), Management with executive […]
According to the Code of Federal Regulations (21 CFR 211.192 Production Record Review), the failure […]
Design controls are a set of quality practices and procedures that are designed to ensure […]
Good Documentation Practices, also known as GDocP, is an important function of Good Manufacturing Practices […]
GMP Trends Annual Report states observations pertaining to facility training programs were in the top […]
Before you can start validating a method for analytical testing on your instrument, you first […]
Do NOT wait for the FDA to come a-knocking! Pharmaceutical manufacturers often wait until after […]
According to 21 CFR 211.186 and 21 CFR 211.188, mater production records must be prepared […]
According to the FDA Guidance Document, Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients, […]
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