EDGAR GRIGORIAN
VP, Technical Affairs
Genysis Labs


Contract laboratories have the opportunity of working with companies that supply and manufacture products. Such companies may drastically differ in size, expertise, products and testing needs. Interactions between the contract lab and suppliers and/or manufacturer include anything from answering routine test inquiries to providing complex, custom tailored test solutions to clients with unique ingredients and product formulations. These interactions are critical to the success of the lab and supplier and/or manufacturer. This article identifies five areas where additional discussion, training and improvements are needed to facilitate further progress.


Fit-for-purpose methods discussion is not a new topic. Discussion has often focused on proper test platform and method selection specific to herbal ingredients and finished products. However, the fit-for-purpose topic also applies to areas outside of botanical identification category. Several categories, such as fiber, fat, protein and vitamin analysis methods fit in this discussion category. Determining the proper method for fiber analysis is a great example. The method options and subsequent prices vary greatly whether the desired results are for total dietary fiber, total fiber (CODEX definition), total fiber with resistant oligosaccharides and so on. Understanding the proper differences and available methods in advance can save a lot of valuable time, money and potential investigations down the road.

Understanding the differences in the active compounds present in products and requesting the appropriate analysis methods with the required selectivity and sensitivity is an area that is in need of improvement. One example of this is analysis of certain vitamins that have more than one form. Vitamin B12 has various forms, and therefore, the method needs specific requirements. Along with Vitamin B12, the other typical suspects that fall in this category are various forms of Vitamin E, Vitamin A, Vitamin B3, Vitamin B6 and others. Most of the current methods have the selectivity to provide results for a specified form in these categories. Therefore, requesting the accurate analysis specific to the active compound form present in the product is critical for the timely and accurate completion of the analysis.

Companies need to better understand their ingredients, especially those that fit in the encapsulated category. Encapsulation of active ingredients is a commonly used practice to preserve shelf life, increase bioavailability, improve taste and flavor profile. Various pathways exist for encapsulation of active ingredients and understanding the encapsulation process is important for analysis to ensure the sample extraction process is optimized for maximum recovery of the active ingredient. Recovery of the same analyte, using the same method in a sample that is encapsulated compared to one that is not encapsulated, may vary significantly, thus resulting in potential for inaccurate results. Large categories of fat soluble vitamins, water soluble vitamins and other active ingredients in the sports nutrition category utilize encapsulation technologies. Understanding the intricate details of the active ingredients and its functionality is important when performing analytical testing for label claim verification. Working closely with the partner laboratories to share important information pertaining to encapsulation of active ingredients in the best interest of all involved parties.

Ingredient certificate of analysis review is critical when determining a test plan for the qualification and ongoing quality control analysis program. In many instances, the reference methods listed on the vendor certificate of analysis are not routine methods offered by laboratory groups within the United States. One of the most common examples that illustrates this point is the amino acid ingredient category. Typical vendor certificates reference a potency analysis method by titration, while the vast majority of the methods offered for the amino acids are based on liquid chromatography platforms with pre- or post-column derivatization of amino acids. Method differences can result in variability specific to instrument or method of choice. Considering the potential differences in advance will help to ensure that the material qualification process is robust. Another area specific to certificate of analysis review process is ensuring that the ingredient meets the specific requirements important for the end user. These can be items such as bulk density, particle size distribution, heavy metal content, pH, color consistency and other attributes not specifically called out on the certificate. A well rounded review by qualified experts will ensure laboratories are performing the right tests within a well-defined scope.

The process of laboratory shopping based on “passing” results is still common. Instead of accepting the first acceptable analytical result – which may not meet manufacturer specification – a test is repeated at another laboratory until an acceptable result is obtained. Sometimes the result differences between laboratories may not be significant and within measurement of uncertainty, but the specification is just barely met or not met. In the current landscape of increasing transparency, the companies should do their best to engage with the various laboratory groups to better understand the reasons behind result discrepancies. If the laboratory engagement is lacking in this critical step, regardless of the passing results obtained from this partner, the decision to use this laboratory as a testing service provider should be evaluated in great detail. Transparency of the process doesn’t mean getting every single detail about a specific method or a process, but a general overview that can provide the visibility to solve the problem on hand.

The process of laboratory shopping based on “passing” results is still common. Instead of accepting the first acceptable analytical result – which may not meet manufacturer specification – a test is repeated at another laboratory until an acceptable result is obtained. Sometimes the result differences between laboratories may not be significant and within measurement of uncertainty, but the specification is just barely met or not met. In the current landscape of increasing transparency, the companies should do their best to engage with the various laboratory groups to better understand the reasons behind result discrepancies. If the laboratory engagement is lacking in this critical step, regardless of the passing results obtained from this partner, the decision to use this laboratory as a testing service provider should be evaluated in great detail. Transparency of the process doesn’t mean getting every single detail about a specific method or a process, but a general overview that can provide the visibility to solve the problem on hand.

The amount of great progress made during the past several years is evident with the increasing consumer awareness, transparency and trust initiatives channeled through various industry leading brands, trade groups and health advocates. It is in our best interest to continue to build on and make improvements to the good foundation that’s been laid out to ensure future growth and prosperity.


About the author — Edgar Grigorian, VP of Technical Affairs at Genysis Labs, has 12 years of experience in the dietary supplement industry. Prior to his current role, Edgar also served as a laboratory director at Genysis Labs. He has extensive expertise with lab management, method development, validation and quality management system implementation per ISO/IEC 17025:2005 standard. Edgar holds a BS degree in chemistry (biological emphasis) from the University of Utah.