European Pharmaceutical Review

JANUARY 25, 2024

Therefore, extractables and leachables assessment should consider the packaging components of the CCS, including the labelling. However, according to the FDA, this is “less of a concern” for products, such as biological products, that are packaged in glass containers.

Documentation 98

Documentation Method Validation Packaging Labelling 98

GMPSOP

NOVEMBER 15, 2024

Stability testing overview for Pharmaceutical products Pharmaceuticals quality assurance & validation procedures GMPSOP %title% Prev PREVIOUS POST Pharmaceutical products must maintain quality, safety, purity and efficacy throughout their specified shelf-life conditions up to their nominated expiration date.

Packaging 59

Packaging Dosage Documentation Labelling 59

GMPSOP

OCTOBER 26, 2022

By implementing robust validation protocols, pharmaceutical companies can ensure that their products are safe, effective, pure and of the highest quality. A scenario where validation is required The management of your company has recently decided to install an information management system in analytical laboratory.

Documentation 52

Documentation Method Validation Packaging Pharmaceutical Companies 52

GMPSOP

MAY 31, 2024

A validation master plan provides a holistic view of all validation activities your site should engage in for a set period (e.g., The VMP should provide information on: – Which items are subject to validation or qualification? – Schedules of validation. Method validation master plan?

Documentation 59

Documentation Method Validation Pharmaceutical Companies Pharmaceutical Companies 59

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