MHPM H P C O N S U L T A N T S, L L C

Pharmaceutical Technology NOVEMBER 1999

Michele Piepoli

  Pharmaceutical companies are seeking more than simply a contract laboratory that can provide analytical results. Outsourcing has evolved into a partnership between the client and the laboratory. The author provides an overview of the current roles and responsibilities of a contract laboratory and discusses the steps involved in building a successful outsourcing partnership.

  The relationship between contract laboratories and their clients has evolved significantly over the years. In the 1970s, the process of submitting a sample for analysis was fairly simple: A client would call the laboratory, and a verbal agreement would be made. The laboratory would receive the sample, complete the analysis, issue a final report, and mail the report to the client. Today, however, both parties follow a completely different process.
  This article provides an overview of the current roles and responsibilities of a contract laboratory and discusses some guidelines for pharmaceutical companies to follow when evaluating the quality of a laboratory. The goal in outsourcing is no longer simply submitting a sample for analysis and obtaining a result. Today, prospective clients seek a contract laboratory with whom they can develop an ethical, longstanding, proactive partnership.
  Outsourcing involves a broad range of services. A pharmaceutical company's needs can be long term, short term, and/or project specific. The main benefit of hiring an outside laboratory is access to the in-depth technical capabilities offered by a single organization. Outsourcing can eliminate the need for additional staff, facilities, and/or equipment. Many clients prefer to keep some projects in-house while outsourcing others that are more detailed and sophisticated.

STEPS TO BUILDING A PARTNERSHIP
  First, a company must select a contract laboratory. Because the pharmaceutical industry is regulated by current good manufacturing practices (cGMPs) and good laboratory practices (GLPs), the contract facility must be able to perform analyses in accordance with these regulations. The client then must determine its needs and expectations and communicate them to the laboratory. Remember, the laboratory a client chooses should be considered an extension of its own facility. The quality of the work performed on- and off-site must be identical. It is the responsibility of both the pharmaceutical company and the contract laboratory to ensure this quality.

  If the contract laboratory defines guidelines that it advises following (e.g., protocols and methodology), then the client has the obligation to determine the validity and regulatory basis for these suggested guidelines. Communication is key -after all, this is a partnership.
  A company should create a comfort zone between itself and the laboratory by visiting the facility and conducting an on-site evaluation. This visit provides the client an opportunity to review standard operating procedures (SOPs) and to get a feeling about the technical excellence of the laboratory.
  The client then must plan a facility audit. An audit is a tool to evaluate a laboratory's processes. The audit should include a tour of the facility and observation of the staff at work. The client should note how comfortable it feels and/or is made to feel in the laboratory.
  It is important that the laboratory have specific protocols in place and, even more critical, that it follow these protocols. A company must evaluate several key issues to ensure that the laboratory it selects is in compliance with cGMPs and/or GLPs. General questions include

SAMPLE MANAGEMENT ISSUES
  Handling samples can seem like a juggling act. Specific protocols that define the process must be in place to prevent anyone from dropping the ball. The client should review

CALIBRATION ASSESSMENT
  The days of simply running an assay are long gone. Laboratories now are required to prove their diligence and verify that their instruments, no matter how simple or complex, operate within specified criteria. Key areas to evaluate include

REFERENCE STANDARDS
  An assay depends on the quality (purity) of the standard against which it is quantified. It is critical that criteria be defined for the handling of standards within the facility. Some areas for the client to review include

REAGENTS AND SOLUTIONS
  In an analysis, a reagent is used by itself or as part of a solution (typically a volumetric solution). A client should review all documentation for

ANALYTICAL METHODOLOGY
  Analytical methodology is a key area that must be evaluated in detail. Methods must be suitable for analytical use. When CGMP regulations apply, all methods of analysis must be validated. In particular, the client should ask

STAFF
  Companies must ensure that the laboratory has documented evidence showing that it verifies employee training. The company should

DOCUMENTATION REVIEW
 This step is the traceability path. A pharmaceutical company must be confident that the integrity of the sample and all analyses will not be compromised. The client should carefully review the laboratory notebook protocol to ensure that a record will be in place that will allow the client to reconstruct the analysis from the time the sample leaves its facility to the time of archival of the final report.
 Although it can be overwhelming, meticulous, detailed documentation is critical for cGMP and GLP compliance. With documentation comes document control. Clients should review the systems that are in place at the laboratory to ensure full document control. Areas to evaluate include

CONCLUSION
  Of course, the entire outsourcing process goes full circle. There are critical steps from start to finish -from the time the sample arrives at a client's facility to archival of the final report. If even one event is not in compliance, the circle is broken. A proactive, successful outsourcing partnership is created when both parties are committed to the process. All analytical and regulatory needs must be met. A high level of integrity, trust, and technical excellence must be established. In the end, both partners' dedication to creating a beneficial alliance will drive long-term success.

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