Analytical instruments used within a GMP environment need to be both qualified and validated. This is done because both the firmware that is used within the analytical instruments, as well as their software that comes into interaction with a play station that is situated adjacent to it, are computerized.
The guideline for analytical instrument qualification (AIQ) is part of the General Chapter <1058> within the USP. This guideline spells out the requirements for analytical instrument qualification.
Challenges of Analytical Instrument Qualification and System Validation
This said; the fact is that the USP 1058 simply sets out requirements for Analytical Instrument Qualification; while focusing on the instrument part of the validation process, it emphasizes very little on computerized system validation, which is also paired to the instrument, whose integral part it is.
The analytical instrument qualification, in turn, has its own guideline in the form of the GAMP Good Practice Guide for Validation of Laboratory Computerized Systems. In particular, the second edition of this validation guide is focused almost exclusively on the computerized system, while very nearly ignoring the parts relating to instrument qualification.
Leads to confusion and half results
When analytical instrument qualification is seen as being disparate from the system validation, the result is that professionals are often confused and feel insufficient about which of these to use. So, analytical instrument qualification and system validation need to work in tango. While it is not advisable or safe to validate the computer system without first qualifying the instrument; the opposite is equally true.
A few instances of actions
Since late 2012, there has been added vigor in bridging and unifying the core aspects of AIQ and CSV. Some actions from different pharmacopeias and regulatory bodies of the world have aimed at achieving this objective. For example, in Europe, the new version of Annex 11 needs to be seen in combination with Chapter 4.
It is thus to be noted that only a combined approach to analytical instrument qualification (AIQ) and computerized system validation (CSV) will help professionals optimize laboratory systems using USP and GAMP.