Validation of Spectrometry Software: Critique of the GAMP Good Practice Guide for Validation of Labo

In this column over the past few years, I have not mentioned in any great detail guidance documents on computer validation but started the discussion on a specific topic from the regulations themselves. This is due to the fact that most guidance has concentrated to a large extent on manufacturing and corporate computerized systems rather than laboratory systems including spectrometers.

This has changed with the publication of the Good Automated Manufacturing Practice (GAMP) Forum's Good Practice Guide (GPG) on Validation of Laboratory Computerized Systems (1). However, this publication needs to be compared and contrasted with the AAPS publication on Qualification of Analytical Instruments (AIQ) (2). Both publications have been written by a combination of representatives from the pharmaceutical industry, regulators, equipment vendors, and consultants.

Overview of the Guide

Published in 2005, the stated aim of the GPG is to develop a rational approach for computerized system validation in the laboratory and provide guidance for strategic and tactical issues in the area. Section 5 of the GPG also notes that: ". . . the focus should be on the risk to data integrity and the risk to business continuity. The Guide assumes that these two factors are of equal importance" (1).

However, the GPG notes that companies must establish their own policies and procedures based upon their risk own management approaches. Of interest, the inside page of the GPG states that if companies manage their laboratory systems with the principles in the guide there is no guarantee that they will pass an inspection, and therefore: caveat emptor!

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Robert D. McDowall
Spectroscopy, Apr 1, 2006

1 comment:

himanshu sahoo said...

The development of a drug product is a
lengthy process involving drug discovery,
laboratory testing, animal studies, clinical
trials and regulatory registration.