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8.8 - Laboratory Controls - Method Validation 211.160 EP or other recognised test

SKU: 11439600703

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Description

EP or other recognised test methods

Each lot of components

and suitably located to facilitate operations for its intended use

Training by qualified personnel shall be in the particular operations that the employee performs and in relevant GMP

8.8 - Laboratory Controls - Method Validation 211.160 EP or other recognised testAll test procedures developed in house require method validation. Compendial methods taken from USP, EP or equivalent, and from accredited sources, for example AOAC, must be verified for each sample matrix by qualified personnel. Methods requiring validation must be added to the VMP, prioritized by risk assessment

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