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LCGC Europe-09-01-2014

LCGC Europe

The Role of Chromatography Data Systems in Fraud and Falsification

September 01, 2014

Questions of Quality

27

9

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.

Rapid UHPLC Method Development for Omeprazole Analysis in a Quality-by-Design Framework and Transfer to HPLC Using Chromatographic Modelling

September 01, 2014

Features

27

9

This article describes ways to apply quality-by-design principles to build in a more scientific and risk-based multifactorial strategy in the development of an ultrahigh-pressure liquid chromatography (UHPLC) method for omeprazole and its related impurities.

Vol 27 No 9 LCGC Europe September 2014 Regular Issue PDF

September 01, 2014

Issue PDF

27

9

Click the title above to open the LCGC Europe September 2014 regular issue, Vol 27, No 9, in an interactive PDF format.