GMPSOP

OCTOBER 26, 2022

In general, you must formally validate all process steps, production equipment, cleaning methods, testing methods, computer systems and environment, facilities and utilities which are directly used for the manufacture of sterile and non-sterile products. This validation is relatively less comprehensive.

Documentation 52

Documentation Method Validation Packaging Pharmaceutical Companies 52

GMPSOP

MAY 31, 2024

Following are some examples of validation studies which should be included in the validation master plan: 1. Process validation master plan The process validation master plan accounts for all manufacturing and packaging processes directly employed in the manufacturing and packaging registered products.

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