There is a wide diversity of analytical instruments and computerised systems used in today's GMP regulated analytical laboratory and software is pervasive throughout these instruments and systems. Regulations, both EU and US, require that these instruments and computerised systems are controlled and are fit for their intended use. Control of laboratory computerised systems is achieved by a combination of validation, qualification and calibration and once validated the validation status has to be maintained throughout the life time that the system is operational.
Regulations are fine but they only say what is required and not how to achieve and maintain the validated state. Guidance in the form of the GAMP guide is often referred to for help with validation of laboratory computerised systems but this is not often specific enough for systems used in a regulated laboratory. To help, the GAMP Forum published a Good Practice Guide (GPG) for the Validation of Laboratory Computerised Systems in 2005 and this was aligned with GAMP 4. In the first edition, all items of laboratory equipment including computerised systems were classified into one of seven different categories which made it difficult to compare with computerised systems operating outside of the QC laboratory which were classified using the classic software categories of 1 - 5. Since then GAMP 5 has been published which was risk based and incorporated much more flexibility into the validation for an individual system, however, being risk based meant that there was a greater divergence between main guide and the Laboratory GPG.
Therefore a volunteer team has been working on writing a second edition of the Laboratory GPG with the main objective of aligning it with the principles and approaches in GAMP 5. This has resulted in the new edition being larger and with 12 appendices covering specific topics for the laboratory. One outcome of the new edition is that the seven categories have been discontinued and replaced with a risk based approach using the general software categories available in GAMP 5. Another change is the title which becomes: Risk-Based Approach to GxP Compliant Laboratory Computerised Systems. The GPG has gone to press and is scheduled for publication in June.
Some of the principles in the new version of the GPG will be covered in ECA's Education Course Maintaining Laboratory Computer Validation from 19 - 20 June 2012 in Prague, Czech Republic.
Bob McDowall PhD,
Director R.D.McDowall Limited
Principal, McDowall Consulting