Use of Contract Analytical Laboratories: A Pfizer Global Biologics Perspective - By following key strategies, companies can reduce the risk and increase the benefits of outsourcing analytical developm


Use of Contract Analytical Laboratories: A Pfizer Global Biologics Perspective
By following key strategies, companies can reduce the risk and increase the benefits of outsourcing analytical development and testing

BioPharm International
Volume 22, Issue 7

Risk: Having too many people involved in the day-to-day communications creates confusion.

Although constant communication is one of the most important best practices to follow when using a contract laboratory for analytical testing, it is also important to limit the number of people involved in the day-to-day discussions that take place between the sponsor and the contract analytical laboratory.

Recommendation: Two main points of contact should be established at each site: one person to work on the business aspects of the relationship and one point person to handle technical and scientific issues. By having these main points of accountability, both the contract analytical laboratory and the sponsor can avoid confusion about what information has been disseminated and to whom. The sponsor also can ensure that the correct questions are being asked, the right answers are being provided, and the appropriate people are involved in the exchanges. For example, if there is a change to an analytical method that has been transferred to the contract laboratory, the single point of accountability from the sponsor's organization and contract laboratory will effectively disseminate this information, thus ensuring consistent information exchange.

It is still important to have communication and interactions with all aspects of the contract analytical laboratory's organization, but such meetings can be set up at regular intervals, whereas day-to-day communications are handled by the two point people mentioned above.

Choosing the people to be the single points of accountability in each area is also key to a successful relationship between the sponsor and the contract analytical laboratory. The sponsor should ensure that the people chosen have the proper knowledge and tools to be successful in their roles.

Risk: Regulatory actions are taken against the contract laboratory.

Recommendation: The sponsor should research the history and past performance of a contract analytical laboratory to ensure that the contract analytical laboratory meets all regulatory requirements and has established quality systems in place. It is also critical that the sponsor understand the dynamics and deliverables of the contract laboratory's quality system to ensure that it will mesh with the sponsor's quality system.

Then, after a relationship with a contract analytical laboratory has been established, diligence should not waiver. It is imperative that the sponsor continue to monitor the level of quality at the contract laboratory with audits, regular communications, meetings, and updates on testing. The business contract and the quality agreement are critical in establishing the framework and understanding what each party is responsible for. These two documents are the foundation of the relationship that will go a long way toward establishing a strong compliant relationship.

In addition, the sponsor should also be using more than one contract analytical laboratory for testing. This way, if a problem is detected at one contract analytical laboratory site, testing can be pulled quickly and sent to other established contract site with minimal disturbance to the timeline for the compound being outsourced.

Risk: The contract laboratory does not fully understand the technology used in methods transferred, including method nuances.

Recommendation: From our experiences with analytical method transfers, both internal and external, one of the key factors in a successful transfer is ensuring that the receiving analytical laboratory has a full technical understanding of the methods being transferred, as well as any nuances the methods might have.

Taking the time, up front, to ensure that this understanding exists, can save countless hours of troubleshooting by the sponsor during and after the analytical method transfers. This can be accomplished by performing face-to-face training with the contract analytical laboratory (analysts from the sponsor can travel to the contract analytical laboratory, or vice versa). It cannot be stressed enough that this is a critical aspect in the relationship or partnership with the contract laboratory.

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