R.D. McDowall | Authors

R.D. McDowall is principal of McDowall Consulting and director of R.D. McDowall Limited, and "Questions of Quality" column editor for LCGC Europe, Spectroscopy's sister magazine.

Articles

What’s Good About the WHO Good Chromatography Practices Guidance? Part 2

In September, the World Health Organization (WHO) issued a new guidance document on Good Chromatography Practices. What guidance does it contain and is it useful? Has the document failed its system suitability test (SST) acceptance criteria?

Are You Controlling Peak Integration to Ensure Data Integrity?

Chromatography data systems (CDS) have been at the center of multiple FDA 483 citations and warning letters, with an emphasis on peak integration and interpretation of chromatograms. Here, we review the issues associated with ensuring compliance when performing peak integration.

Data Integrity and USP : Part 3: Monitoring and Requalification

This is the final part of a trilogy looking at the impact of the new USP on analytical instrument qualification (AIQ) on data integrity in a regulated chromatography laboratory. This part will focus on the performance qualification (PQ) portion of the 4Qs model and, specifically, monitoring and requalification of chromatographs.