Column: Questions of Quality - LC-GC Europe
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Column: Questions of Quality

Comments on the GAMP Good Practice Guide for Validation of Laboratory Computerized Systems, Part 2

01 September 2006

The fundamental aim of any computerized system validation should be to define its intended use and then test it to demonstrate that it complies with specification.

USP <1058> Analytical Instrument Qualification and its Impact on the Chromatography Laboratory

01 June 2009

United States Pharmacopeia (USP) general chapter 1058 on analytical instrument qualification (AIQ) has finally become official and was released in August 2008 in the first supplement to the USP XXXI.1 This column reviews AIQ and discusses the impact it will have in the regulated chromatography laboratory.

Are You Validating Methods for Bioanalytical Samples?

01 April 2009

This column discusses the similarities and differences between the validation approaches for analytical methods for QC product analysis and bioanalysis.

What's New in the Regulatory World?

01 October 2008

The regulatory world and associated guidance documents within the pharmaceutical industry is changing rapidly. This column gives an overview of what's happened since the start of the year.

What Does Good Laboratory Practice (GLP) Mean?

01 June 2008

You may work in a chromatography laboratory to quality standards but do you work to Good Laboratory Practice? Probably not...

The 2008 Update of US GMP — Why Not Include the Laboratory

01 March 2008

The four eyes approach is a cornerstone of any quality system (GMP, GLP or ISO 17025): a first person performs a task and a second person checks it.

Security and Access Control Requirements for Computerized Systems

01 November 2007

Information from guidance documents used in clinical investigations can be very useful to help meet FDA regulations regarding computer security in analytical laboratories.

How Able Are You?

01 March 2007

Users need to understand not only the operation of the computer system as required by their access privileges, but also the ethics and integrity required operating under any of the GMP or GLP quality systems.

GAMP Good Practice Guide for Validation of Laboratory Computerized Systems, Part 1

01 May 2006

The best parts of the GAMP laboratory system GPG are the life cycle models for both development and implementation of computerized laboratory systems.

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