CHAPTER 15: Validating Analytical Procedures Check Access

Validation of Analytical Procedures is to ensure that there is the right analytical procedure for the right job and represents Level 2 of the Data Integrity Model described in Chapter 5. The correct operation of Level 2 is predicated upon the correct implementation of Foundation (Data Governance and Data Integrity) and Level 1 (Analytical Instrument Qualification and Computerised System Validation). Currently ICH Q2(R1) is used for validation of analytical procedures in a GMP context but this does not take a life cycle approach as advocated by ICH Q8, the latter guidance takes a holistic approach to controlling pharmaceutical processes. In several stimuli to the revision process articles, the United States Pharmacopoeia Validation and Verification expert committee have proposed a life cycle approach to the validation of analytical methods that has culminated in publication of a draft general chapter USP <1220>. An updated FDA guidance for bioanalytical method validation guidance only now has started to consider method development but not in the same degree of depth as the USP approach. In light of the USP update, ICH Q2(R1) will be updated to a life cycle approach. Regardless of the approach to validation, it is imperative that analytical procedures are validated, under control and that a laboratory knows the impact of changing key variables in the procedure.