SWE Maintenance and Calibration Management Conference 

Harmonization of Protocols for Service, Maintenance Reports, GLP/GMP Multi-Vendor Instrument Validation

A case study on the "Harmonization of Protocols for Service, Maintenance Reports, GLP/GMP Multi-Vendor Instrument Validation" will be presented the SWE Maintenance and Calibration Management Conference at the La Jolla Marriott outside San Diego, CA, March 8-9, 2007. 

The presenters are Joseph Tehrani, PhD, global business leader, Multi-vendor Validation and Relocation Solutions, PerkinElmer Life and Analytical Sciences, and Arthur Boyer, PhD, Multivendor Validation Program Manager, also of PerkinElmer. They will present the case study at at 1 p.m. Thursday, March 8, 2007.

The trend in most pharmaceutical organizations is moving toward vendor-neutral service providers because of the need for business as well as compliance simplification. 

Many pharmaceutical companies have acquired a complex array of instruments for laboratory testing in the GLP/GMP (GxP) compliance environment. These instruments are many times daunting to manage since they are manufactured by different vendors, have multiple models and are used in multi-vendor configurations. (For example, a typical LC/MS/MS system is composed of an injector made by company X, HPLC pump made by company Y and triple quadruple mass spectrometer manufactured by company Z.)

GxP validation protocols and compliance data generated by companies X, Y, and Z are usually dissimilar with lengthy reports, difficult to comprehend, and most often do not test the overall function of the complete configuration.

One step in reducing the complexity of the validation process and, therefore, harmonize the management process, has been to develop a unified protocol (e.g., for LC/MS/MS) that covers all instrument configurations from instrument companies A - Z. 

At this point it becomes easier for a laboratory manager to understand, control, document and defend validation data and manage preventative maintenance (PM) and service to reduce regulatory risk. Prior to this point, the validation data from various vendors may be too complex and ill-documented to understand. Unfortunately, the overall system (holistic) validation may be completely overlooked and, therefore, the instrument validation may be suspect.

A straightforward and easy to follow protocol provides a solution to the problem by supplying a clear procedure for validation for all configurations from all instrument companies A - Z, or broad sub-set thereof.

Examples of LC/MS/MS validation data will include multi-vendor configurations with generic, transparent protocols designed to effectively streamline GxP instrument compliance, service and PMs. Minimization of down time allows the pharmaceutical scientist to maximize throughput of mission critical samples.

For more information about the SWE Maintenance and Calibration Management Conference visit the SWE website at: http://www.sweinc.biz or view the show agenda.