GMPSOP

NOVEMBER 19, 2023

Component quality A review of all starting materials and primary packaging in contact with the product should be completed. This will include supplier performance assessment and identifying any critical deviations associated with active or excipient ingredients, primary packaging and closure material. Subscribe f.

Documentation 52

Documentation Packaging Method Validation Process Improvement 52

GMPSOP

OCTOBER 28, 2023

Validated test method A test method comprehensively describes all procedures used in sample analysis. Analytical test method validation guarantees that your test method is robust enough to provide evidence if your product meets the predetermined product specification or conforms to the failure of a product.

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 52

Documentation Method Validation Packaging Data Entry 52