10. November 2020
An in-process revision to USP <1058> on Analytical Instrument Qualification (AIQ) was issued for public comment in the May-June 2015 issue of Pharmacopoeial Forum. What has changed in this version of USP <1058>?
The introduction has been expanded and now includes mention of risk assessment and risk management being essential to undertaking AIQ. The section on the instrument groups has been brought forward to the introduction from the back of the current general chapter and the criteria presented but in contrast with few examples are given as the group an instrument is in depends on the intended use. In the sections on installation qualification and operational qualification there is the requirement that purchased packages must be reviewed pre and post execution. An improvement is that the OQ needs to be performed on the software configuration used for analysis to integrate computer validation with instrument qualification. The instrument parameters to qualify are to be found in the instrument specific general chapters of the USP. In the PQ phase there is a requirement for periodic review of critical computerised systems.
From the software perspective, the reference to the FDA's guidance on general principles of software validation has been replaced by GAMP 5 and the GAMP Lab Systems Guide 2nd Edition which are far more pertinent to laboratory instruments and systems than the FDA's document. There is mention of verification of instrument calculations and control of user defined programs that are both missing in the current version of <1058>. There is increased granularity of software as <1058> now considers configured and customised lab computerised systems but the section on standalone software has been deleted from the proposed update.
Instead of definition of validation and qualification, there is now a glossary of 7 terms at the back of the document.
For detailed information on this USP in-process revision to USP <1058> on Analytical Instrument Qualification (AIQ) , please see the USP website of Pharmacopeial Forum (PF).
Dr Bob McDowall
Director R D McDowall Ltd., UK