Data Integrity and USP : Part 1 Specifications and Suppliers
July 1st 2018This is the first of three articles looking at the impact of the new United States Pharmacopeia (USP) chapter on Analytical Instrument Qualification (AIQ) on data integrity in a regulated chromatography labora-tory. In part 1, user specifications for chromatography systems and the relationship between users and sup-pliers will be discussed.
Paper, Paper Everywhere but None of it Controlled?
September 1st 2016One of the common threads in the six data integrity guidance documents published to date is the need to control any blank forms used in regulated GXP laboratories. This month’s “Questions of Quality” is focused on how to interpret the regulator’s requirements for this topic. We also pose the question: Is paper the best way to record regulated data?
The Role of Chromatography Data Systems in Fraud and Falsification
September 1st 2014Chromatography 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 1st 2014A 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?
Can You Meet the Technical Requirements of Annex 11?
July 1st 2012The 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.