8.8 - Laboratory Controls - Method Validation 211.160 and suitably located to facilitate

and suitably located to facilitate operations for its intended use

You must control the issuance and use of packaging and labels and reconciliation of any issuance and use discrepancies

such as head

identity testing

including but not limited to batch disposition decisions

8.8 - Laboratory Controls - Method Validation 211.160 and suitably located to facilitateAll 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