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!

Table I: Contents of the GAMP GPG on validation of laboratory computerized systems

The guide consists of a number of chapters and appendices as shown in Table I. As you can see, the order of some of the chapters is a little strange. For example, why is the validation plan written so late in a life cycle, or why is the chapter on training of personnel positioned after the validation report has been written? However, at least the main computer validation subjects are covered in the whole life cycle, including system retirement. The GPG also cross references the main GAMP version 4 publication for a number of topic areas for further information wherever it is appropriate (3).

One major criticism is that the nine references cited in Appendix 5 are very selective and therefore, the GPG ignores some key publications in this area:

• Furman and colleagues (4) on the debate of holistic (or system) versus modular validation or qualification. This paper was written by FDA personnel on the validation of computerized chromatographic equipment; ignoring it is not an option as it provides a scientific rationale for this two-level approach.
• PDA Technical Report 18 (5) on validation of computer-related systems that contains a much more specific computer validation definition than the FDA process validation definition quoted in Section 3.1 of the GPG (6).
• AAPS Analytical Instrument Qualification (2) white paper published in 2004, which was the outcome of a joint FDA-AAPS conference from 2003.