For some time now, one could follow the development of a USP General Chapter
dealing with the qualification of analytical instruments in the Pharmacopoeial
Forum. After several draft versions had been presented and commented, not long
ago the General Chapter <1058> was published in the first supplement of the USP
31 / NF 28 (2008), which comes into force on 1 August 2008.
As is well known, General Chapters with numbers larger than
<999> are only recommendatory. Nevertheless, the pharmaceutical industry is glad
that, with this chapter, it has now an official regulatory basis for the
qualification of equipment in pharmaceutical quality control. Up till now, the
qualification approaches had to be deduced and adopted from general
recommendations, e. g. from Annex 15 to the EC GMP Guide (Qualification and
Validation). With General Chapter <1058> there is now a solid basis for
analytical instrument qualification on the part of the pharmacopoeias. This is
not surprising, since the specific requirements on the calibration and
monitoring of analytical instruments have long been included in the general
equipment-related chapters of the pharmacopoeias.
The new USP chapter recommends the well-established
qualification phases also for analytical instruments:
- Design Qualification
- Installation Qualification
- Operational Qualification
- Performance Qualification
One interesting fact is that, by performance qualification, the
periodic checks of the instrument in defined intervals are meant, i.e.
performance qualification now includes the regular calibration activities,
preventive maintenance and necessary repairs over the whole runtime of the
individual device - naturally taking change control into consideration.
What is especially helpful for daily practice is the USP's
proposal of a stepped model for different categories of instruments. It suggests
Group A (simple equipment)
Group B (among others for thermometers, pH meters, refractometers)
Group C (computer-based devices, like HPLC, GC, NIR, etc.)
For these different groups, the range of qualification measures can be laid down
in a stepped way in the companies.
Moreover, this chapter also includes a brief statement on
Dr Günter Brendelberger
On behalf of the European Compliance Academy (ECA)