Instrumentation Qualification (IQ/OQ/PQ)
OUR CLIENTS
Quest Diognostics
Pharmasol
CoNCERT
Aspenti health
Tarveda
Dr. Reddy's
RTI International
Genzyme
Blend Therapeutics
Abbott
Harvard University
Massachusetts Institute of Technology
Test America
Sunkist
Boston university
Phenomenex
USGS
Pioneer
Schwabe
Pfizer
Translate bio
Amgen
USPS
Why are Instrument Qualifications Necessary?
To ensure a product is safe and meets its intended use, method validation and instrument qualifications are necessary. Qualifications (IQ/OQ/PQ) provide a systematic approach to confirming that each instrument is proven to be accurate and precise. This process should be both scientifically strict, but also straightforward and repeatable.
Overbrook Qualification Services Includes:
Total Qualification Program (TQP)
The Overbrook Support TQP provides a choice of qualification options for both the GLP/cGMP facility and the pre-clinical laboratory. Properly trained and experienced service professionals can minimize the burden of running a productive and well-maintained laboratory.
Qualifications (IQ/OQ/PQ)
Qualifications can incorporate existing manufacturer protocol and/or a client’s existing protocols and thus be customized to fit your intended use in accordance with USP <1058>. Qualifications conducted by an independent outsourced service provider, rather than an employee of the company, is important to ensure compliance. Equally important is knowing the mechanics as well as the requirements of USP <1058> .
Installation Qualification (IQ) , Operational Qualification (OQ) , Performance Qualification (PQ) are requested for routine, scheduled qualification of laboratory systems, and for first time qualification of recently purchased instrumentation.
Qualifications are done routinely, after component replacement or repair, following a facility or instrument move in a GLP/cGMP facility, and when subject to inspection, audit or review.
Installation Qualification (IQ)
Documented verification that system components and support systems have been installed correctly and completely. IQ is performed In accordance with manufacturer and customer requirements, government regulations and industry standards.
Operational Qualification (OQ)
Documented verification that system components operate properly in accordance with manufacturer and customer requirements, government regulations, and industry standards. OQ establishes confidence that the components are capable of consistently operating within the established limits and tolerances required by the systems they support.
Performance qualification (PQ)
Performance qualification (PQ) is the documented collection of activities necessary to demonstrate that an instrument consistently performs according to the specifications defined by the user, and is appropriate for the intended use. After IQ and OQ have been performed, the instrument's continued suitability for its intended use is demonstrated through performance qualification.
Juggling is for Circuses.Are you focusing on too many things and not on your science?
