Questions of Quality

Feb 20, 2017
LCGC Europe
Raw data is a term that is used in both good manufacturing practice (GMP) and good laboratory practice (GLP) laboratories but it can create misunderstanding. What exactly does raw data mean and what electronic records are within the scope of the term?
Sep 01, 2016
LCGC Europe
One 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?
Jun 01, 2016
LCGC Europe
In the world of data integrity, the focus is typically on the data and the numbers. How can technology, such as a laboratory information management system (LIMS), help to ensure data integrity?
Jan 31, 2016
LCGC Europe
Data integrity issues are changing the way that we should be undertaking computerized system validation (CSV) of our chromatography data systems (CDSs). Do you understand what is required in the brave new world of CSV?
Nov 01, 2015
LCGC Europe
Primary record is a term that was defined by the MHRA (Medicines and Healthcare products Regulatory Agency, the UK drug regulator) in data integrity guidance issued in 2015. In this instalment of Questions of Quality we explore what this term means in practice, and compare it with raw data in the European Union Good Manufacturing Practices (EU GMPs) and complete data in US Food and Drug Administration (FDA) GMPs. Why can’t we have harmonization of terms?
Jun 01, 2015
LCGC Europe
A question that keeps raising its head when working in a regulated laboratory is can chromatographers integrate peaks manually? If they can, when can they do it? Also if they can manually integrate, when should they not do it?
Feb 01, 2015
LCGC Europe
This instalment of “Questions of Quality” looks at problems with an operational liquid chromatograph to see if they can be picked up in the performance qualification (PQ) or prevented in the operational qualification (OQ).
Sep 01, 2014
LCGC Europe
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.
Jul 01, 2013
LCGC Europe
The concluding part of the article from last month's "Question of Quality" on what "complete data" actually means in practice.
Jun 01, 2013
LCGC Europe
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.
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