31 August - 3 September 2021
USP General Chapter <1058> Analytical
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:
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
Moreover, this chapter also includes a brief statement on software validation.