European Pharmaceutical Review

NOVEMBER 21, 2024

For further information, visit: www.criver.com About the authors Courtney Wachtel, BS is Product Manager, Microbial Solutions, Charles River – Endosafe. The post Understanding endotoxin cartridge testing: frequently asked questions appeared first on European Pharmaceutical Review.

Method Validation 52

Method Validation Pharmaceutical Manufacturing 52

GMPSOP

SEPTEMBER 27, 2023

Cleaning validation verifies that the cleaning procedure can consistently and significantly reduce the amount of active ingredients, excipients, and cleaning agents to a concentration within the acceptance limit. Why is cleaning validation required? If it is not, analytical method validation is required.

Method Validation 98

Method Validation Documentation Pharmaceutical Manufacturing Dosage 98

GMPSOP

JUNE 9, 2024

Test method validation in quality control Analytical Method Validation for Quality Control Test method validation generally means the same as analytical method validation, where the terms are interchangeable. Maintenance programs must be documented for laboratory equipment.

Method Validation 52

Method Validation Documentation Health and Personal Care Stores Labelling 52

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

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