Risk: The method transfer exercise does not adequately test the contract laboratory's capabilities.

Best Practices for a Successful Analytical Transfer to a Contract Analytical Laboratory

Recommendation: To accomplish this, we believe that a key factor is the design of the method transfer, or more specifically, the choice of the sample set to be used in the analytical method transfer exercise. Often, to save time or for the ease of the sponsor laboratory, analysts at the sponsor site and the contract analytical laboratory perform comparability testing on samples that have already been tested for release at the sponsor site. Although this is acceptable for part of the sample set, it is also important to use spiked or degraded samples in the comparability testing. By using samples that generate results that are out of the ordinary, the sponsor will better demonstrate that the contract analytical laboratory can obtain results equivalent to those obtained in the sponsor's own laboratories.

A key similarity among all of the recommendations given in the above examples is the necessity of constant communication. Communication is key to ensuring that analytical testing performed by a contract analytical laboratory is successful, from both a business and a scientific perspective. Current market trends in the pharmaceutical industry indicate that the use of contract analytical laboratories will only continue to grow, both domestically and internationally, in the coming years. Using the best practices and recommended strategies highlighted here can help sponsors to avoid pitfalls and mitigate the risks associated with the outsourcing of analytical testing.

John Ruesch is the associate director, and Amy St. Charles is a senior scientist, both in QC/Stability/Compliance in the Analytical Research and Development of Pfizer Global Biologics, St. Louis, MO, 636.247.5146, john.c.ruesch@pfizer.com