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contamination
Training by qualified personnel shall be in the particular operations that the employee performs and in relevant GMP
including but not limited to batch disposition decisions
Stability testing must be performed to determine the shelf life of a new product from date of manufacture
8.8 - Laboratory Controls - Method Validation 211.160 contaminationAll 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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