The Challenge

A major pharmaceutical manufacture in Michigan built and commissioned new analytical chemistry laboratories used for quality control testing of multiple products.  The existing laboratories were old and ready for demolition.  All instruments and systems needed to be relocated from the existing laboratories to the new laboratories with minimum impact on QC testing of products.  The goal was zero testing downtime for the analytical testing. 

The Solution

The relocation of all instruments and systems

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 requirements, 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 qualification and calibration test requirements.

The Benefits

Benefits to the client include:

·  Release of over 2000 labor hours of client research scientist/ quality analyst in 2004 by outsourcing HPLC qualification testing to PCI.  Thus, allowing those resources to be applied toward assay test and 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.