Articles by R.D. McDowall - Chromatography Online
Articles by R.D. McDowall

R.D. McDowall

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

The Role of Chromatography Data Systems in Fraud and Falsification
September 1, 2014

Chromatography data systems (CDSs) have had a starring role in many regulatory citations involving falsification and fraud in analytical laboratories regulated by Good Manufacturing Practices (GMP). In this instalment of "Questions of Quality" we will examine the citations and identify the technical and procedural controls required to ensure data integrity within these systems. Although focused primarily on the pharmaceutical industry, the principles described here are applicable to all laboratories working to established quality standards.

Life Cycle and Quality by Design for Chromatographic Methods
February 1, 2014

A recent stimulus to the review process article by the United States Pharmacopoeia (USP) Expert Committee is proposing a major change in the way regulated laboratories develop, validate and control analytical procedures. Is this Quality by Design (QbD) for the chromatography laboratory?

How Complete Are Your Chromatographic Data? Part 2
July 1, 2013

The concluding part of the article from last month's "Question of Quality" on what "complete data" actually means in practice.

How Complete Are Your Chromatographic Data?
June 1, 2013

This article will explore what is meant by "complete data" in the context of a chromatography data system and, with an analysis of FDA 483 citations, explore the problems when a laboratory fails to understand this phrase.

How Much Value Is There in a Software Operational Qualification?
March 2, 2013

Answers to common questions about operational qualification software.

How Much Value Is There in a Software Operational Qualification?
February 1, 2013

Answers to common questions about operational qualification software.

Getting It Write?
November 1, 2012

Written procedures used by trained staff are the basis for all quality systems but there are many ways of writing a procedure. Are you getting it write?

Can You Meet the Technical Requirements of Annex 11?
July 1, 2012

The new version of EU GMP Annex 11 has been effective for about a year. There are new technical requirements in the Annex – do your laboratory computerized systems comply with them all? In this column we look at the impact of these new regulatory requirements for Good Manufacturing Practice laboratories.

Fat Finger, Falsification or Fraud?
April 1, 2012

Mistakes or fat finger moments are part of human nature but where is the dividing line between this and falsification and fraud?


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