HPLC Qualification (IQ/OQ/PQ): Ensuring Data Integrity for Your Laboratory
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.
For instrumentation to be properly qualified, there are a lot of things to consider. The performance of the asset needs to be comprehensively evaluated, while not keeping it out of operation for too long. While the development and implementation of standard operating procedures can be intimidating, a trusted professional service provider partner such as Overbrook can develop a comprehensive and quick qualification standard for your instruments.
Overbrook Support Services offer integrated maintenance
and qualification services. With an innovative, multi-platform, harmonized analytical instrumentation model, your current protocols can be utilized or qualification documentation can be customized to ensure your instrumentation’s performance and data is proven to be accurate and precise. Trust your instrumentation qualification needs to a skilled, experienced team, and get the peace of mind you need to continue your everyday operations.
Overbrook Support Services conducts Integrated Maintenance and Qualifications for big pharma, smaller biotech, cannabis testing and pharmaceutical firms. This maintenance contract features Periodic Maintenance (PM) along with Operational Qualification (OQ). An innovative, multi-platform, harmonized analytical instrumentation qualification service for the makes and models of chemical analysis systems we service. The platform incorporates existing manufacturer protocols and/or client’s existing protocols and thus can be customized to fit the intended use in accordance with USP <1058>.
This service offering is especially appealing to labs with multiple vendor (mixed) instrumentation, first time qualification of recently purchased systems, or re-qualification after repair or relocation. Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ), and Validations (IQ/OQ/PQ) uses one standard approach regardless of instrument manufacturer, simplifying protocol administration.
Overbrook Qualification Services Include:
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 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.
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.
