Regulatory Review of Method Validation Protocols

“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.

Change, while scary, is a necessity. Opportunities for increased efficiency, higher profitability, and the ability for an organization to maintain a competitive advantage necessitate the need for change. Correctly adopting new liquid chromatography (LC) technology can be very challenging, however, when done correctly, modern LC technology can give a laboratory the ability to simplify method transfer across a diversity of analytical LC platforms at all of its facilities.

The first three articles in this series discussed where and how a CDS fits into a regulated laboratory, the overall requirements for the architecture of a future system, and additional items to enable effective electronic ways of working. The final part of this series looks at regulatory compliance of a future system as well as a summary of the 15 recommendations made in this series.