Regulatory Review of Method Validation Protocols

Protecting your network chromatography data system (CDS) data is critical and a service level agreement (SLA) with your IT provider is vital. What should be included? Are SLAs for in-house IT and SaaS (software as a service) similar?

The European Commission's regulation on maximum levels for certain contaminants in food highlights the need for precise and reliable methods to quantify per- and polyfluoroalkyl substances (PFAS) in various food matrices. This article discusses development and validation of a robust method for analyzing 21 PFAS compounds in chicken eggs using solid-phase extraction (SPE) and liquid chromatography–mass spectrometry (LC–MS).

“Questions of Quality” is 30 years old! What, if anything, has changed in chromatography laboratories over that time?

The new General Chapter <621> does reflect the great work of the Pharmacopoeias in helping chromatographers to use more modern technology for their regulated methods, speeding up analysis, and reducing waste. The latest revision allows us to adjust column dimensions for gradient separations, which is a significant advance. Although these freedoms are welcomed, one must be very mindful of the requirements or limits of the allowable changes and the verification work that underpins our demonstration of equivalent performance of the adjusted method.

The lack of proper method validation has important implications in blood alcohol concentration (BAC) determinations. We examine this issue, addressing the importance of gas chromatography (GC) for BAC determination, why certain validation procedures are important, and why accreditation bodies need to step up their game.

The advantages of a risk-based approach to instrument replacement are discussed.