The Challenge
A major pharmaceutical manufacturer in Indiana had several hundred HPLC systems that required tighter control via periodic mainenance and requalification. The systems are located in different geographic locations within a site complex and are used for functionally different applications. Approximately 30% of the units are located in research and development labs while the balance of the instruments are in quality control labs.

The Solution
A pilot project was conducted to identify implementation issues and verify that program goals could be achieved. The pilot project showed that instrument owners had similar functional instrument requirements but had not standardized the types of instruments purchased leaving many different makes of instruments from lab to lab. Several labs were serviced by multiple manufacturers (OEMs). Some labs have hybrid units where the system pumps, detector and injectors further complicating the service issue. Each lab had setup different serviced requriedments, tests, and pass/fail criteria. The pilot also showed there were discrepancies between calibration of instruments and qualification results.

On completion of the pilot program, a PCI team was developed to support qualification in the various laboratories. As new laboratories were added to the project scope, PCI assisted in qualification protocol review and upgrade/harmonization where possible. Once updated qualification protocols were in place and training complete, the PCI onsite teams performed qualifications for that laboratory.

High emphasis was placed on close coordination with the instrument owner and the responsible maintenance shops to minimize operational impact on the owner and lost equipment availability. The existing maintenance management program for the site was used to schedule qualification activities.

The Result

• PCI executed over 200 HPLC qualifications in 2004 for this client with an average time to complete a qualification reduced to less than one half the time of the previous approach.
• Qualification protocols were reviewed and updated where applicable resulting in improved qualification harmonization between areas.
• A reduction of calibration failures was recognized through better harmonization of qualifcation and calibration test requirements.

The Benefits
Benefits to the client include:

• Release of over 2000 labor hours of client research scientist / quality analyist in 2004 by outsourcing HPLC qualification testing to PCI. Thus, allowing those resources to be applied toward assay test adn other quality control responsibilities.
• A significant improvement in the availability of analytical laboratory instruments.
• An overall hard cost savings in analytical laboratory instrument maintenance.
• A dramatic improvement in the control and therefore compliance of laboratory instruments.

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