There is an increasing trend to outsource laboratory work in pharmaceutical quality control and research laboratories. The benefits and risks of outsourcing this work have been assessed and debated for more than 25 years. We will discuss the factors that have critical impact on a successful partnership with a contract laboratory.

Recent surveys show that the success of an outsourcing partnership depends on several key factors. Some of these are more obvious and of a technical nature, such as the strength of the lab’s Quality Control (QC) and Quality Assurance (QA) units. Today the non-traditional, less technical factors such as process improvement, communication, and customer service are just as important^{1, 2}. This paper will emphasize the importance of using both technical and non-technical criteria when selecting a contract laboratory. 

Why Outsource?

Originally, the pharmaceutical industry outsourced laboratory work that a firm either couldn’t perform (e.g. due to lack of a laboratory) or didn’t want to perform (e.g. testing of hazardous materials). As the industry underwent significant changes in the early 2000s, new approaches had to be found to solve growing issues of decreased laboratory resources — staff and new equipment — and the need to improve efficiencies and performance with less capital. Using a contract laboratory became a viable option to:

• Maintain a leaner staff on-site while contracting work to an ‘extended staff’ at an outside lab,
• Expand the amount of work by utilizing a contract lab, or
• Outsource work requiring specialized expertise and/or equipment (instrumentation) and methods while overall reducing expenses.

Compliance and Responsibility

It is important to note that selecting a contract laboratory does not remove any responsibilities from the client. The client firm that owns the material or product being tested is ultimately fully accountable for the testing and results. Responsibility is shared by the contract laboratory and the client, yet results interpretation and final disposition of tested materials lies in the hands of the client alone. Accountability starts from the initial evaluation of the contract lab, the oversight of all materials being tested, and the reporting of methods, results, deviations and investigations that may occur. 

Identifying a Contract Lab Partner: Step-by-Step

Once the need and the decision to outsource are well defined, many systematic steps must be taken to choose an acceptable contract laboratory. In general, the critical steps in selecting a good contract laboratory partner are:

 

• Obtaining recommendations from peers and other reliable sources,
• Identifying a short list of potential contract labs,
• Assessing the lab(s) with a questionnaire audit, followed by an on-site audit,
• Applying “hard” and “soft” selection criteria (Table 1) to further vet selected lab(s), and
• Using quality tools, (e.g., risk-based approach, Table 2) to apply to the specific project at hand.

 

Peer recommendations from fellow scientists are an important source to help identify a contract partner. A good or unfavorable experience will affect the possibility of continuing or starting a new partnership with a laboratory. Geographic location can also be a factor in the selection of potential labs, if time and cost in shipping of samples and/or frequent face-to-face communication are important. Cost containment is generally not a critical factor in the decision, since many laboratories with similar capabilities will charge essentially the same for a given project. 

Once a short list of potential partners is identified, the next step is to assess each lab. First, surveys or questionnaires are filled out by the contract laboratory. Next, an on-site visit should be performed to get a personal overview of the laboratory, its people and their capabilities and their quality systems. A prepared set of questions should be developed for the on-site audit that can help the customer accurately determine the suitability of the contract lab for the current project. Quality tools — such as weighted attributes analysis to rank each potential laboratory — can also help guide the selection process.³

 

The subsequent steps involve a systematic assessment of contract laboratory selection criteria. The following criteria, listed and defined in Table 1, are important to consider in the initial assessment and subsequent on-site audit. 

 

The list on the left-hand side in Table 1 comprises the more routine and perhaps more obvious portion of the overall contract laboratory selection criteria. Any reputable laboratory will certainly have a robust QA system and group, sufficient IT systems, and good documentation practices, as well as the inspection history, training and the technical expertise to perform the project. A firm that has an active performance improvement program and is evaluating the processes for improved efficiency and effectiveness on a regular basis has a significantly better chance of being a successful partner. This type of program can develop long-term sustainability.

All seven of the technical criteria in Table 1 focus on whether the contract laboratory can properly perform the job. Do they have the appropriate QA/IT/ GMP/GLP systems in place, as well as adequate documentation, training and a good inspection history with regulatory bodies? All of these “hard” criteria should be critically evaluated with your scientific peers, the questionnaire audit and the like. In summary, do you feel the lab can do the job as shown by past performance and experience? 

Once the considered lab appears to have the appropriate tools to conduct the work, the two “soft” criteria, shown on the right-hand side of Table 1, should carefully be considered. Communication and cultural match go hand-in-hand: do you feel comfortable, based on the prior technical assessment, with talking and working with the lab on a day-to-day basis, perhaps for an extended period of time? Conversely, will the lab feel comfortable with you in quickly identifying issues and communicating informally — between scheduled meetings — when needed? Can you and your laboratory partner work as a team to accomplish the goals of the project? Deeply held beliefs and values, routine practices, ideas and knowledge must all be carefully considered before going forward and signing the contract. 

Lastly, do you feel the lab is overall proficient in most or all of these nine criteria? If so, they are probably a good candidate to seriously considering working with. 

Quantifying the Final Selection Process: A Risk-based Approach 

While using the list shown in Table 1 should help start the process to accept or reject many contract laboratories as potential partners, implementing a risk-based approach may help finalize and even quantify the final selection process. Similar to the weighted attributes analysis³, this can help the client further quantify its decision making process for using or not using a given lab for a given task. 

 

Risk can be defined as:

    Criticality x likelihood of occurrence = score (1)

 

Rating both criticality and likelihood of occurrence from 1-5, a score of 20-25 would be very poor, where a low score of 5 or less would be quite good. Two examples are given in Table 2, which compare and contrast the importance of technical expertise vs. QA oversight for two different projects.
 

The score for Example 1 shows that a laboratory that has very good technical expertise for a complex task cannot override poor QA oversight and an inadequate inspection history. The score for Example 2 shows that for compendial testing, a less demanding task than Example 1, lack of expertise is not as critical but QA oversight is at least as critical. 

This article provided guidance on how to select laboratories by selecting and assessing relevant criteria using a risk-based approach. Identifying both technical and non-technical criteria is recommended in order to capture all the various aspects of a successful work partnership. Every company must determine for itself which aspects of a successful partnership are most important and establish relevant criteria as a first step. Once the criteria are established, a risk-based assessment or other quality tools can be used to make a rational, well-informed decision about which laboratory should be hired for a given project.  

 

Acknowledgements

We would like to thank Chris Knutsen for contributing to this discussion. We also thank Contract Pharma for the invitation to speak at the 2010 Contracting and Outsourcing Conference that led to this article. 

 

References and Bibliography

 

1. Barrett R., “Companies find outsourcing can backfire as quality, customer service suffers”, Milwaukee Journal Sentinel, Nov. 10, 2010.
2. Press Release, Quality Press, “BPO Providers Fall Short on Service, ASQ Survey Shows Process Management Is Top Concern for Companies”, Oct 28, 2010.
3. Choi L. and S. Rudge, “10 Steps for Choosing a Contract Manufacturer”, Bioprocess Intl, Sep 2010, pp 20-28.

 

Quality Risk Management, ICHQ9, U.S. FDA Guidance for Industry, International Conference on Harmonization, June 2006
 

Guidelines for Laboratories Performing Microbiological and Chemical Analyses of Food and Pharmaceuticals, And Aid to Interpretation of ISO/IEC 17025:2005, March 2010, AOAC International Analytical Laboratory Accreditation Criteria Committee, Gaithersburg, Md.

“Contractor Responsibilities in Outsourcing Pharmaceutical Quality Control Testing,” R.M. Nims and E. Meyers, Bioprocess Intl, June 2010, 16-20.

“Outsourcing Stability Programs – Strategies for success,” S.P. Maycock and A . Koltay, Contract Pharma, Nov. /Dec. 2008.

“Outsourcing Analytical Testing – Price is less important than quality,” C. H. Dubin, Contract Pharma, Sept. 2007.

“Bioanalytical Outsourcing – What Factors affect outsourcing decisions?” A.J. DeStefano and S. Lowes, Contract Pharma, Nov./Dec. 2007.

Panel Discussion: Contract Laboratory Criteria, Contract Pharma 2010 Contracting and Outsourcing Exhibition and Tabletop Exhibition, D. Singer, T. J. Edkins and C. Knutsen, Sept. 2010  

 

Donald Singer is Global Lead Manager, Microbiology, R&D at GlaxoSmithKline. He has more than 30 years of research, QA/QC and laboratory management experience. He can be reached at donald.c.singer@gsk.com.

Thomas Edkins, Ph.D. is President of Edkins Pharma Services, LLC, which he founded in 2008, focusing on analytical and bioanalytical chemistry, CMC and technical project management. He can be reached at edkinspharma@verizon.net. Please address all correspondence to Mr. Singer.