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In the latest issue of the Pharmacopeial Forum of January/February 2005,
a suggestion for a new, general USP chapter titled "Analytical Instrument Qualification"
is presented. The starting point for this new USP chapter was a workshop
on this topic in the US, about which we had informed you in our GMP
News of 23 February 2004.
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:
- Group A – Instruments that do not need to be qualified
Examples: Magnetic stirrers, vortex mixers or glass pipets
- Group B – Instruments with a relatively easy installation
Examples: balances, IR, melting point, pH meter, refractometers, viscosimeters, etc.
- Group C – Instruments for which a complete qualification is
necessary
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.
Author:
Dr Günter Brendelberger
CONCEPT HEIDELBERG
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