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 […]
GMP Trends is an FDA Compliance Platform, providing relevant, real-time, and unbiased information reports trending […]
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, […]
According to the Code of Federal Regulations (21 CFR 211.67 Equipment Cleaning and Maintenance), facilities […]
Smoke studies or air flow visualization studies are used in aseptic processing facilities to confirm […]
Verification of lab data is outlined is CFR section 21 CFR 211.194(a)(8) which states: “The […]
For each drug product, there should be a laboratory determination that the product meets final […]
A complaint handling system is a procedure for receiving, reviewing and evaluating complaints in a […]
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