Good manufacturing practise (GMP)

chromatograf · Post by **chromatograf** » Mon Dec 13, 2004 5:21 pm

Hello,
In order to maintain the requirements of work in the mode "good
manufacturing practise (GMP)" for control of medical products we need
validation (qualification) program for analytical data systems.
Will be possible to fulfil this order with use of software Clarity?
Yours sincerely

Post by **Jan Hruby** » Mon Dec 13, 2004 5:21 pm

Hello,
we think the Clarity software is capable to fulfil requirements for
analytical data system qualification.
Commonly, three levels of validation (qualification) are relevant:
1. IQ -Installation Qualification: a procedure confirming that the
datastation was successfully installed and that the installation
contains all the required files of the correct version.
Installation qualification is an integral part of the Clarity
Chromatography datastation installation procedure.
2. OQ - Operational Qualification: a procedure confirming that the
datastation is performing according to the manufacturer's specification.
The Clarity Validation kit serves this purpose. Using a precise peak
generator, chromatographic data is acquired and analyzed with prepared
procedures and the acquired results are compared with expected values.
3. PQ - Performance Qualification: -a procedure confirming that the
analytical system is fit for a given type of analysis.
The Clarity data station offers many tools in the System Suitability
Test (SST) module to efficiently help to evaluate the system
performance.

Jan Hruby