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

MAY 31, 2024

The validation master plan provides the first line of defense that all required validation and qualification activities are performed on a schedule and that their processes are compliant with GMP guidelines. Following are some examples of validation studies which should be included in the validation master plan: 1.

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