GMP News No. 526
8 March 2005
Draft for a USP Monograph
The new USP draft says that there are no specific requirements on or regulations for the qualification of analytical instruments in a GMP-regulated environment - in contrast to the validation of analytical methods or the system suitability test. The text explains that opinions as well as techniques vary greatly as regards analytical instrument qualification. The consequence is that the scope of qualification activities and their corresponding documentation is implemented in very different ways. The new USP chapter is meant to describe a scientific approach to instrument qualification. Analytical instrument qualification (short: AIQ) is considered as a basic prerequisite for the creation of reliable and consistent data. In the preface to this monograph draft, the competent expert committee states that this draft does not yet include corrective and preventive actions (CAPA) to be taken in the event that deviations are found within the framework of a regular performance qualification. Suggestions from industry are welcome.
The text suggests to categorise analytical instruments as follows:
Examples: Magnetic stirrers, vortex mixers or glass pipets
Examples: balances, IR, melting point, pH meter, refractometers, viscosimeters, etc.
Examples: AAS, HPLC, MS, NIR, UV/Vis, GC, etc.
The text rightly points out that this categorisation is just a suggestion. The final categorisation has to be done by the user in the laboratory according to his or her specific requirements.
An interesting feature of this draft for the new USP monograph is the proposed categorisation of the different qualification phases. Here, performance qualification is described as a periodic requalification with regular maintenance and calibration activities. This is a clear difference to the European classification, e.g. as described in Annex 15 to the EU GMP Guide titled Qualification and Validation.
You will be given a complete overview of analytical instrument qualification in the pharmaceutical laboratory at our international GMP Education Course Lab Equipment Qualification to be held in Barcelona from 25-27 April 2005.