Testing Services, Cost-Savings Hallmarks of Independent Labs

Testing Services, Cost-Savings Hallmarks of Independent Labs

What are the strategic benefits of using an outside testing lab?

Bronwyn Hughes, Ph.D., president, Plant Bioactives Research Institute: The main benefit of using a third-party laboratory is that the results are considered unbiased when compared to in-house testing. The outside laboratory can be used to verify in-house test results, thereby confirming the method validity as well as standard purity and identity. Using an outside laboratory is usually less costly initially, due to the high cost of setting up a method and validating the method and the time involved in doing so. Specialty outside laboratories, such as those performing nutraceutical analyses, that have years of experience are generally more experienced in specific analyses and problem solving different sample matrices, etc. The outside laboratories often have instruments that smaller laboratories do not have. In addition, outside labs can prepare standards that smaller labs are not able to prepare for analyses where standards are not commercially available.

Tom Miller, Ph.D., laboratory director, Alpha Laboratories, div. of Eurofins Scientific Inc.: The potential scientific and financial benefits of outsourcing analytical laboratory services are numerous. Outsourcing can significantly reduce a company's overhead costs in terms of physical space and personnel. By focusing on the core business activities, and shifting lab services to outside experts, a company can normally reduce the required, in-house staff to one manager who coordinates this technical interface. Cost reductions for product liability insurance and instrumentation purchases are also possible with a diligent quality assurance (QA) program linked to an independent laboratory. The outside laboratory can serve as a company's scientific partner by providing expertise from its core competency ... independent analytical services. The outside lab's management is completely focused on technical expertise and leadership in dietary supplement methods, state-of-the-art instrumentation and top-notch experienced analysts. Independent third-party testing services also can be advantageous for both QA requirements and for marketing. A company's valuable in-house resources can be leveraged through the effective use of outside labs in these areas. Science-based marketing is an advantage with consumers, and contract labs are capable of providing a broad range of scientific methods and technologies to characterize different products and raw materials.

Randall Smith, vice president of analytical services, Covance Inc.: Companies outsource because they usually do not have the full regimen of methods and expertise in house. In-house capabilities at most organizations typically only cover standard services and methodologies. Outside laboratory testing services are an excellent solution for providing testing procedures that require special expertise, technology and/or methodology. In addition to relying on outsourced experience and methodology, we have found that many organizations use us as a third party to compare and validate results. Generally speaking, projects with strong regulatory or legal issues also tend to be outsourced frequently. Of course, outsourcing is often a strategy used by organizations that find it more cost effective or as the only way to handle overflows of their own capacity.

What are the primary issues manufacturers and suppliers should consider when selecting a testing lab?

Miller: First, scope of services. Does the lab do what we need to have done, does it have the capacity to meet our needs, and is it willing to do special projects? Next, experience. How long has the lab been doing business in our area of interest? Are the people experienced, and is the lab actively involved in the industry? Then quality, including the lab's reputation in the industry, whether it has a documented QA program that has been audited by outside parties and whether clients are permitted to do audits. Finally, customer support and price. Is the lab responsive to our needs, and are services priced fairly?

Smith: The credibility and recognition of a testing lab's scientific practices and methods, as well as its reputation for quality, should always be used as the primary selection criteria. To assure that a testing lab provides a quality service, it is paramount that the lab uses recognized methods as the standard. Secondary issues include capacity, financial stability and experience with the methods desired.

What are the biggest issues in the nutraceutical/functional food industry that testing companies have to address?

Larisa Moore, business development manager, Industrial Laboratories: The biggest issue in the dietary supplement market is that the target is constantly moving for what is the hot ingredient. Due to the nature of the industry, and trends among raw material usage, it is important to watch market trends and to evolve with the industry. Analytical methods development is critical to meet the needs of raw material suppliers as well as contract manufacturers for finished product analyses. Banned substance testing after the Olympics was an issue for a short time period. Testing is possible for banned substances utilizing various analytical techniques such as HPLC and GC/MS. Finally, testing for genetically modified organisms (GMOs) has become a rising concern. Numerous herbal suppliers are beginning to market their products as non-GMO.

Didier Perez, chief operating officer, Investigen: The biggest issue we see is "What are the regulations governing GMO content in foods?" This is an ongoing problem that no one can really answer. It seems that each government wants to implement its own definition as to what level of GMO content needs to be labeled. This has led to a lot of confusion among processors and exporters. On a broader scale, the definition of what constitutes GMO also differs by importing country. There is also the question of contamination level. Zero is a very small number. What is the threshold of advantageous contamination that will be tolerated and not affect the "organic" label? Zero tolerance is unadvisable as it can lead to the unjustified boycott of an essentially clean/free product.

Hughes: The first big issue for the industry is to ensure that material in a product is identified properly. Second, the label claims must be correct, i.e., the active or marker compounds must be present at the levels as stated on the label. Third, stability studies must be carried out on the specific formulations so that expiration dates on the label areaccurate.