8.8 - Laboratory Controls - Method Validation 211.160 identity testing

identity testing

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

and suitably located to facilitate operations for its intended use

Each lot of components

8.8 - Laboratory Controls - Method Validation 211.160 identity testingAll 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