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Cleaning validation protocol for pharmaceutical industry

GMPSOP

Select the worst-case product for cleaning validation For multi-product equipment, it is not practical to validate the cleaning of all products that have one cleaning process and where products are alike in formulation and dosage form. If it is not, analytical method validation is required.

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What are the elements of quality control process in pharmaceuticals

GMPSOP

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.