This document is intended to provide a framework for NHS Pharmaceutical Quality Control laboratories to enable a consistent and robust approach to analytical method validation. The document is written in the context of the quality control testing of unlicensed medicines manufactured under a ‘Specials’ licence and it should be recognised that validation of methods for the purpose of submissions for Marketing Authorisations may need to go into further detail, although the same principles will apply.

Attachments

• Analytical Method Validation Guidance.pdf · PDF · 1 MB