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GMP News No. 526
8 March 2005
NewDraft for a USP Monograph
The new USP draft says that there are nospecific requirements on or regulations for the qualification ofanalytical instruments in a GMP-regulated environment - in contrast to thevalidation of analytical methods or the system suitability test. The textexplains that opinions as well as techniques vary greatly as regardsanalytical instrument qualification. The consequence is that the scope ofqualification activities and their corresponding documentation isimplemented in very different ways. The new USP chapter is meant todescribe a scientific approach to instrument qualification. Analyticalinstrument qualification (short: AIQ) is considered as a basicprerequisite for the creation of reliable and consistent data. In thepreface to this monograph draft, the competent expert committee statesthat this draft does not yet include corrective and preventive actions(CAPA) to be taken in the event that deviations are found within theframework of a regular performance qualification. Suggestions fromindustry are welcome.
The text suggests to categorise analytical instruments as follows:
The text rightly points out that this categorisation is just asuggestion. The final categorisation has to be done by the user in thelaboratory according to his or her specific requirements.
An interesting feature of this draft for the new USP monograph is theproposed categorisation of the different qualification phases. Here,performance qualification is described as a periodic requalification withregular maintenance and calibration activities. This is a clear differenceto the European classification, e.g. as described in Annex 15 to the EUGMP Guide titled Qualification and Validation.