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.
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?
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.
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.
Perspectives in Modern HPLC: Michael W. Dong is a senior scientist in Small Molecule Drug Discovery at Genentech in South San Francisco, California. He is responsible for new technologies, automation, and supporting late-stage research projects in small molecule analytical chemistry and QC of small molecule pharmaceutical sciences. LATEST: Seven Common Faux Pas in Modern HPLC