European Pharmaceutical Review

JANUARY 25, 2024

Over time, these can leach “low molecular weight compounds” such as plasticisers, stabilisers and binding agents from CCS components or from labelling components, like inks or adhesives into the drug product. Moreover, manufacturers should document information about their safety thresholds, the guidance stated.

Documentation 98

Documentation Method Validation Packaging Labelling 98

GMPSOP

SEPTEMBER 27, 2023

A cleaning procedure must be in place before you can initiate cleaning validation for any product, equipment, or facility. At a minimum, the cleaning procedure should contain the following information: – Quantity and concentration of cleaning solution to be used. 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

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

APRIL 3, 2023

– Documentation of all reagents and materials used in the laboratory, including lot numbers, expiration dates, and supplier information. Protocols are only used for specific projects such as method validation testing or equipment qualification. – References used to develop the laboratory protocol.

Documentation 52

Documentation Method Validation Compounding Data Entry 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