Challenges When Qualifying a GMP Analytical Laboratory

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.

The amount of time reviewing documents, especially protocols can be extensive. They amount of reviewing can tax Validation, QA, and System Owners. The development of a template for the IOQ and PQ protocols can simplify the review time for the pre-approval of protocols. The protocols can be designed so that the only items that need to be reviewed are the instrument specific specifications and function testing. The review of executed protocols needs to be scheduled to meet site standards and requirements as well as the timelines of, and to some extent, the preference of the reviewers. Sometimes it is more effective to review all the protocols for one class of instrumentation (i.e. HPLCs) rather than review each protocol as it becomes available. Utilization of a reading room to house the protocols for review can eliminate the need to tracking down who has the protocol and assures that protocols are available when reviewers have the time.

Vendor Activities

Most pharmaceutical companies with laboratories have developed relationships with the vendors that service their instrumentation. Some companies have a designated service technician who has access to the laboratories. This is the starting point for establishing the expectations that the project will have of the vendor.

There needs to be a single point of contact from the project team that can track the Purchase Orders (POs) for new instruments; verify that the PO covers set up requirements as well as verify need for the purchase of the IOQ protocol and its execution. You will need to be kept abreast of any changes to delivery from the vendor and keep the vendor advised of any schedule changes due project slippage. Tight coordination will need to take place so that the instruments show up as soon as the space is available to help maintain the overall project timeline. Qualification can’t take place until the instruments are in place with all the appropriate utilities and all the appropriate support systems in place.

Depending on the size of the project, an additional person may be needed from the project team to help manage vendor expectations. Division of duties by vendor is recommended. Sites that have designated vendor technicians can find having these technicians both a help and a hindrance. The help is obvious, they know you, your site, your instruments and how you normally do business. The hindrance comes into play when you are operating under a new set of guidelines for the new lab; this needs to be communicated. Upfront communication of changes in operational standards is key.

Clear direction needs to be given as to who is responsible for the staging, set-up, installation, calibration and IOQ of the instruments. It may vary with each type of instrument. Before the instrument is delivered you should know if the vendor or lab services is going to stage (unpack boxes) or set-up/install (connect tubing, install software, configure system). Nobody wants to void any warranties nor do you want to circumvent the standard way instruments are received and established in the corporate systems.

Assume that for, at least, the more complicated instruments, the vendor is going to install and perform the IOQ on the instruments, how the protocol is going to be pre-approved and execution oversight will need to be established. Most validation departments require vendor protocols to be pre-approved before execution. Telling the vendor early and often can help ensure that the IOQ documents are available in time to review and pre-approve. Reviewing the vendor protocol against the standard site requirements for IOQ will help identify the gaps in the vendor protocol (usually site specific). These gaps should be listed on the pre-approval page with an indication as to where these gaps will be addressed. Generally any gaps from the vendor IOQ are addressed in a site-established supplemental IOQ. The pre-approval signatures should include a Quality Assurance signature. This signature helps give reassurance that all gaps in the vendor protocol have been identified.

The purchasing, installation and IOQ of a new instrument should be straight forward, so long as expectations are clearly communicated. Vendor oversight during execution will need to be made on a case by case basis. Because it is a new space, will they need assistance in knowing where everything is or where it should be placed? Do they need oversight for completing documentation? Or ensuring that Preventative Maintenance (PMs) and service calls documentation is done per GDP? When it comes to documenting system failures and repeating tests, vendor protocols may give more leeway than site-established protocols. If you want them to adhere to a higher standard, it needs to be communicated.

Qualification of a laboratory is not just a Validation and Laboratory project, it encompasses multiple functional groups. The commitment to the project by the key cross-functional groups are paramount to the success of the project. The coordinating of vendor activities and minimizing the effect to existing activities are two of the more complex challenges incurred when qualifying a new laboratory or relocating an existing lab. The communication of the project needs and the acceptance of their roles by the vendors; the Quality organization (QA, management and analysts) and Support Services is the key to a successful laboratory qualification project.

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