12-14 December 2023
In the Pharmacopeial Forum No 42(3), the USP has published the draft for the revised General Chapter <1058> "Analytical Instrument Qualification". This draft takes into consideration the comments sent to the USP. Besides, some formal aspects have also been modified to bring this chapter into line with USP's today usual phrasing.
There are many possibilities to demonstrate that an instrument is qualified and under control - amongst others with qualification, calibration, validation and maintenance. An integrated approach - based upon a risk assessment - is recommended to demonstrate that an instrument is suitable for its intended purpose. Here, data integrity and security are essential aspects.
This approach isn't a unique process but the result of different activities over the lifecycle of an instrument. This way, Design Qualification (DG) can be performed both by the instrument manufacturer or the user in the lab.
If there is a remaining instrument in the lab which hasn't been qualified before or can't be qualified according to the currently valid standards, the existing documents should be compared and evaluated by means of a risk assessment to determine the best approach.
Furthermore, it is stated in the revised draft that Operational Qualification (OQ) relies on the fixed parameters of an instrument such as length, height, weight or pressure. Such fixed parameters which cannot change over the lifecycle of an instrument do not need to be retested later.
If an instrument is moved to another location, an assessment should be performed to decide whether and what qualification activities have to be repeated.
The classification in three groups A, B and C depending on the complexity of the instruments has proven to be sound and will be retained.
You can find the draft of the revised General Chapter <1058> "Analytical Instrument Qualification" on the USP Pharmacopeial Forum webpage.