Overbrook Support Services conducts Integrated Maintenance and Qualifications for big pharma and smaller biotech and pharmaceutical firms. This maintenance contract features Periodic Maintenance (PM) along with Operational Qualification (OQ).
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 can incorporate existing manufacturer protocol and/or client’s existing protocols and thus be customized to fit your intended use in accordance 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 HPLC, GC, GCMS, LCMS, LC-MS/MS. 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)
Documented verification that the total system performs as intended. PQ establishes confidence that the system as a whole is capable of consistently performing within established limits.
With Qualifications by Overbrook Support Services, instrumentation data has integrity, in accordance with manufacturer, customer, government regulatory and industry standards. That’s why some clients have us perform Qualifications on a semi-annual basis. Qualifications assure that general system operations function correctly, audit trails capture correct information, and so on.
Overbrook Support Services offers a single, harmonized qualification protocol for all makes and models of chemical analysis systems. Currently there are existing protocols for LC, GC, GCMS, LCMS, LCMSMS, auto samplers and other instrumentation.
Qualifications by Overbrook Support Services allow clients to
- Reduce operational costs
- Minimize protocol administration burdens
- Maintain control with traceability and streamlined support through one service provider.
Traceable calibration of measurement tools, traceable chemical reference standards and standard operating procedures (SOP) are included.
Sometimes during a Qualification, an instrument fails. In this case, real time failure resolution may be performed by the service engineer on site. Managing repairs of analytical instrumentation is where Overbrook Support got its start and continues to expertly perform for its clients.