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
validation needs. The Distek Pharmaceutical Validation Services Group offers
products and services in the areas of Installation Qualification
(IQ), Operational Qualification (OQ), Mechanical Qualification (MQ), Performance Qualification
(PQ), Performance Verification Testing (PVT) and Preventative Maintenance (PM),
as well as ASTM Method E2503, any of which can be purchased 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, and all proper connections and accessory
installation will be checked.
Operational Qualification (OQ) and
Mechanical Qualification (MQ)
Verifies the system is functioning and that
all critical operational parameters are within stated specification.
This certifies that the mechanical performance of the system is
satisfactory and that the system is available for further
performance qualification.
Performance Qualification (PQ)
Ensures that the
system is working properly. We will verify and certify that the
instrument meets Performance Verification Test (PVT) requirements
per USP <711> guidelines using USP RS tablets.
Preventative Maintenance (PM)
Assures 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.
Operational Qualification/Performance
Qualification (OQ/PQ)
Certifies that your UV-Vis
Spectrophotometer or HPLC System performs within specified
requirements with documented results.
Click here
for a list of services offered.
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