GMPSOP

OCTOBER 28, 2023

The analyst should ensure that the supervisor is notified as soon as an OOS event occurs, the sample is retained, and a documented investigation is commenced. Validated test method A test method comprehensively describes all procedures used in sample analysis. Additional documents included each month.

Documentation 52

Documentation Method Validation Packaging Data Entry 52

GMPSOP

DECEMBER 24, 2023

Laboratory documentation and records that should be available include: – Test methods and test reports – Laboratory notebooks/sheets, instrument records, and calculations – Conditions of tests and instrument settings. – Test method validation protocols, data and reports – Other records and data i.

Documentation 40

Documentation Method Validation Packaging Data Entry 40

GMPSOP

NOVEMBER 19, 2023

You must have a summary of all complaints or adverse events during the review period. All validation/qualification studies commenced or completed during the review period must be assessed. The effectiveness of the validation must be determined. Details of how each issue was resolved should be provided.

Documentation 52

Documentation Packaging Method Validation Process Improvement 52