Regulatory Standards, GLP and GMP Compliance

September 1st 2023

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

February 3rd 2023

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.

August 1st 2022

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.

April 6th 2022

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