Validation and Calibration
Much like our philosophy for designing quality
instrumentation, Distek’s Pharmaceutical Validation Services Group utilizes highly
skilled chemists and technicians dedicated to meeting your needs for
dissolution validation. The Distek Pharmaceutical Validation Services Group offers
products and services in the areas of Installation Qualification
(IQ), Operational Qualification (OQ), Performance Qualification
(PQ), and Preventative Maintenance (PM) on a one-time or annual
contract basis.
Installation Qualification (IQ)
Assures your instrument is received in good
condition and as ordered. We will confirm the system meets
product specifications. The system will be inspected to verify it is
in good working condition, all proper connections and accessory
installation will be checked.
Operational Qualification (OQ)
Verifies the system is functioning and that
all critical operational parameters are within stated specification.
The key parameters checked and verified for a dissolution system
are; level, height, centering, wobble, RPM, vibration and
temperature.
Performance Qualification (PQ)
The purpose of the PQ is to certify, with
documented evidence, the performance of a Dissolution system as per
the system suitability test requirements of USP Chapter <711> using
USP calibrator tablets.
Preventative Maintenance (PM)
Is performed to assure that the system
continues to operate properly and that no component becomes
incompatible due to use. All electronic and mechanical components
will be inspected and replaced as necessary.
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