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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.

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Documentation Method Validation Packaging Data Entry 52
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Typical GMP documentation in a quality control laboratory

GMPSOP

APRIL 3, 2023

There are also forms, logs, and registers to keep track of all the little details, as well as product specifications, analytical methods, manufacturing formulae, calculation of raw data and more. Sometime these are labelled as the “hidden factory”. Adapted and non-standard methods must be validated.

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Documentation Method Validation Compounding Data Entry 52
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