8.8 - Laboratory Controls - Method Validation 211.160 to ensure the quality

to ensure the quality

including but not limited to batch disposition decisions

EP or other recognised test methods

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

identity testing

8.8 - Laboratory Controls - Method Validation 211.160 to ensure the qualityAll 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