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What are the elements of quality control process in pharmaceuticals

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
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Concept of validation in pharmaceutical industry

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
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