Challenges When Qualifying a GMP Analytical Laboratory

Source: ProPharma Group, Inc.

Expanding an existing lab or establishing a new lab is an exciting time; new equipment, new facility, a fresh start.  The key to having a successful laboratory qualification project is communication of needs, communication of timelines and realistic expectations for supporting departments.  There are a few challenges to getting a new lab up and running in a timely manner.  Two major challenges, the coordinating of vendor activities and minimizing the effect to existing activities, will be discussed here.

Existing Activities

When adding a laboratory to an established site, there needs to be a considerable amount of planning as how to utilize resources with a minimal impact to current operations.  The Validation department isn’t the only department that will need to designate resources to the project.  Metrology and Lab Services will need to know early on how many and what of kind instruments for which their services will be needed.  They will need to be updated as the instruments are scheduled to be delivered.  The intent is to make the most effective use of the supporting department time.

Subject Matter Experts (SMEs, lab personnel) normally provide technical support with the more sophisticated instrumentation.  Most analysts are at capacity (otherwise we would not need the new lab and new people); the activities that they are supporting could have precedence over the new lab.  The schedule in regards to required existing testing should be known so that support to the new lab can be scheduled without conflicts.  Lab management will need to be verbal about the importance of support to the new lab so the analyst knows when to free up some time to support the new lab.  Support for the new lab could also include the training of new analysts which can also place a strain on resources.  The biggest strain on resources occurs when relocating a lab.  Even when it is done in a phased approach, personnel are stretched to complete testing when equipment is functional in either the new or existing lab only.