10. November 2020
In the January/February issue of Pharmacopeial Forum (volume 38, issue 1) a stimulus to the revision process was published for USP <1058> on Analytical Instrument Qualification. The proposal is based around a more detailed risk assessment for all apparatus, instruments and systems used in a regulated analytical laboratory.
The current weakness of the overall risk-based approach to the validation of computerised systems is the way in which software is assessed. From a software perspective, the GAMP 5 Good Practice Guide (GPG) for Laboratory Computerised Systems has wide recognition within the industry and regulators but it is not consistent with some of the elements of <1058>. This USP General Chapter <1058> is currently under revision.
The GAMP GPG for Laboratory Computerised Systems is also under revision and is due to be published in Q2 this year.
As a conclusion of the article in PF 38 (1), a new risk-based life cycle model is proposed that extends the current <1058> approaches and makes the chapter compatible with the second edition of the GAMP 5 GPG for the validation of computerized laboratory systems. A harmonized and integrated approach to the validation and qualification of instrumentation, hardware, and software is achievable. The use of the 4Qs model is no longer recommended.
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The authors of this article, Chris Burgess and Bob McDowall, are the teaching team for the ECA Education Course "Integrating Analytical Instrument Qualification and Computerised System Validation, from 16-17 April 2012 in Prague, where discussion and a workshop on this risk assessment methodology is featured as part of the comprehensive programme. The members of the teaching team have also contributed to the new edition of the GAMP GPG for Laboratory Computerised Systems. This course is an ideal opportunity to learn about the new publications in this topic from the teaching team who have been involved in both documents.
Dr. Günter Brendelberger
CONCEPT HEIDELBERG (a service provider entrusted by the ECA Foundation)