Two documents can help ensure successful outsourcing of laboratory services: a quality audit and a quality agreement
April 16, 2004
BY ELIZABETH FOWLER and CAROLYN CARDIN
| The accelerating pace of drug development, coupled with rapid advances in analytical techniques for characterization of these drugs, has significantly increased the demand for testing capacity. Outsourcing good manufacturing practices testing to contract testing laboratories has become an important means of satisfying this demand.
For small biotech companies, outsourcing often provides access to expertise and facilities that do not exist in-house. For larger companies, outsourcing obviates the need to expand existing capabilities and minimizes the risk of over-investment in internal capacity. In both cases, outsourcing can decrease the startup time as well as the personnel and capital investments required to build and maintain state-of-the-art laboratories.
With the right partners involved, the results of the collaboration can exceed what the partners could accomplish separately. The keys to developing a synergistic relationship are identifying the right partner, clearly defining expectations, and communicating regularly and honestly.
Before spending an ounce of energy on scoping out an appropriate lab, however, the biotech or pharma should first thoroughly examine its own needs — and not just testing needs. Some oft-neglected, "softer" areas of initial self-examination include an assessment of what type of interaction suits a particular company's need.
In other words, would you like to be integrally involved in the testing of your samples, or would you prefer to take a hands-off approach throughout the process and receive the final data when the lab gets them to you? Are you looking for a one-shot deal, or will you be establishing a longer-term relationship with a company to do routine testing? Will you be working with or relying on the contractor in the future to contribute to regulatory filings?
|Four Keys to
- Compatible culture
- Clearly defined expectations
- Partnership philosophy
- Extensive and open communication
When searching for an appropriate contract testing laboratory, network with your peers, current or former colleagues, professional organizations, and other companies with which you have worked that might have similar products that they entrust to a contract tester. A simple Internet search can yield a boon of potential candidates. The trick is to find one whose capabilities are the best match for your testing needs.
The first contact you have with a potential contract lab is when you need to convey your specific analytical needs, as well as your project time frame. Even if the lab's technical capability appears to fit your testing needs perfectly, this won't help much if the lab cannot test your samples fast enough. The lab must also be able to provide the official results within the needed time, and not be slowed by its own internal quality-assurance turnaround times.
Beware of companies that may overestimate their capabilities in meeting aggressive timelines. The lab should be able to provide customer references for you to check.
The next step — which is, in fact, the first step in qualifying the organization — is a site visit. This is essential for evaluating both the technical capabilities and the corporate-culture fit of the potential contractor.
You should also perform a quality and compliance audit. During a quality audit, details such as data handling, excursion investigations, and client-notification procedures should be thoroughly reviewed.
Employee training and experience should also be reviewed. Pay particular attention to sample handling and tracking and equipment use, as well as calibration and maintenance programs. As a rule of thumb, a quality audit of a contract testing lab should focus on the cross-contamination and mix-up-prevention controls as manifested in the organization's quality systems and practices.
After you've audited and chosen a contract lab partner, it's wise to draft a quality agreement to define and solidify the mutual understanding and expectations of both companies. It benefits both parties to put one in place before starting work, especially if your company is engaged in relationships with multiple contract testing organizations. A quality agreement will document the details and establish the definitions of the quality aspects of the relationship, avoiding (and sometimes helping to resolve) any potential future disputes. Make certain the agreement specifically addresses the major quality aspects and exactly what role you, as the sponsor, will play.
Forging a solid working relationship with a contract lab requires considerable effort by both parties. The best results arise from aligned expectations and excellent communication between the sponsor and the contractor.
|Lab Services Outsourcing:
Steps to Success
As the sponsor, you must be accessible without being overbearing, timely without being anxious, and specific without being draconian. Contract testing labs are in the business of meeting their timeline commitments. Just as you expect consistency from the contractor, a lab will greatly appreciate consistency from you.
A specific person should be identified as the project manager and given the responsibility of interacting with the contract lab. This person should be familiar with the results of the original quality audit, the details of the quality agreement, as well as the internal timelines and requirements of his or her company. Technical experts on both sides may communicate directly, but the project manager should be aware of all these communications, and no changes to the work plan should be implemented without the project manager's knowledge.
The relationship between a sponsor and its contract testing laboratory can only be as good as the collective efforts of both parties. In pulling their respective "weights" in the relationship, both parties can reap the mutual benefits of high quality, timely work, and continued joint endeavors.
Elizabeth Fowler is vice president, quality and regulatory affairs, for Xcellerex. E-mail: firstname.lastname@example.org. Carolyn Cardin is director of quality assurance for Xcellerex. E-mail: email@example.com.
PHOTO ILLUSTRATION OF HANDS/BEAKERS BY TERRY MIURA