ICH Q7 - Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
Section 6: documentation and records – ICH Q7 - Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients

ICH Q7 - Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients 6.6: Keep complete laboratory control records: samples, methods, weights, raw data, calculations, results against criteria, analyst signature and second-person review

What does 6.6 require?

Laboratory control records should hold complete data from all tests used to confirm compliance with specifications and standards, assays and examinations included: a description of each sample (material name or source, batch or code, sampling date and, where relevant, quantity and date received); the test method used; the sample weight or measure; data on, or a pointer to, how reference standards, reagents and standard solutions were made and tested; all raw data including identified graphs, charts and spectra; all calculations with units and conversion or equivalency factors; the results and how they compare with acceptance criteria; the analyst's signature and test dates; and a dated signature from a second person confirming the records were reviewed for accuracy, completeness and compliance. Complete records should also be kept of changes to established methods, periodic calibration of laboratory instruments and recorders, all API stability testing, and out-of-specification investigations.

Maintained by Gerard Blokdyk

Other controls in Section 6: documentation and records – ICH Q7 - Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients

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