GMPSOP

SEPTEMBER 27, 2023

However, you must validate the condition and efficacy of their use by conducting trials. Cleaning validation, including analytical method validation, should be conducted for the new product. If it is not, analytical method validation is required. Additional documents included each month.

Method Validation 98

Method Validation Documentation Pharmaceutical Manufacturing Dosage 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. You can read our article “ Equipment Cleaning in Pharmaceutical ” to explore cleaning validation further.

Documentation 59

Documentation Method Validation Pharmaceutical Companies Pharmaceutical Companies 59

GMPSOP

APRIL 3, 2023

Adapted and non-standard methods must be validated. Protocols are only used for specific projects such as method validation testing or equipment qualification. – Methods for data analysis and interpretation, including the statistical techniques to be used.

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