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Cleaning validation protocol for pharmaceutical industry

GMPSOP

Cleaning validation verifies that the cleaning procedure can consistently and significantly reduce the amount of active ingredients, excipients, and cleaning agents to a concentration within the acceptance limit. Why is cleaning validation required? If it is not, analytical method validation is required.

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Concept of validation in pharmaceutical industry

GMPSOP

What is method validation in pharmaceutical industry? Analytical method validation involves demonstrating that the analytical methods used to test the quality of your product are accurate, reliable and reproducible which is critical for ensuring the quality and safety of your products.

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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.