THIRD-PARTY VERIFICATION & VALIDATION
Eliminating Bias and Conflicts of Interest.
According to current Good Manufacturing Practices (cGMP), manufacturers are responsible for ensuring that a finished product meets established specifications for purity and claimed amounts of the active ingredients on the label using reliable and valid methods. However, cGMPs do not define or specify what methods would be considered “reliable” and “valid,” which provides manufacturers with plenty of flexibility and wiggle room when it comes to finished product validation. While some companies have their own manufacturing facility and in-house lab where all the testing is performed, others work with contract manufacturers who either perform the testing in their in-house lab or outsource the testing to contract labs. At NutriGold we work with contract manufacturers who perform routine testing of raw materials and finished products per cGMP requirements, but because our standards are far more stringent than current GMPs, we test every lot of our raw materials and finished products for compliance with industry defining quality standards using independent, third-party labs.
Why use independent, third-party labs?
Independent testing labs are not affiliated with the raw material supplier, the manufacturer, the consumer, or the company whose name appears on the product; this means they have no vested interest in the outcome of the testing and are less likely to “dry lab” or manipulate test results for self-serving reasons. In addition to lending objectivity to the process of ensuring finished product quality and integrity, working with independent, third-party labs has other key advantages as well including:
- There is no commercial bias present, so both manufacturers and consumers can have greater confidence in test results.
- The time to get test results can be shorter because independent labs specialize in testing and have competencies and efficiencies that cannot be matched by in-house labs.
- Independent, third-party testing organizations often have specialized facilities with state-of-the-art testing equipment that are suitable for even the most challenging assays.
- Personnel working in specialized testing laboratories often have excellent experience, credentials, certifications, and accreditations.
At NutriGold our decision to partner with an independent, third-party lab is based on an evaluation of the lab’s quality standards, accreditations, the education and experience of their personnel, and their capabilities and competencies. Provided below is a brief summary of the industry leading testing labs we work with to validate our raw materials and finished products.
We do what we do best, which includes obsessing about the details related to product integrity and quality, so you can do what you do best - take care of you and your health.
NutriGold's Independent Third-Party Labs
Alkemist labs, an independent contract-testing laboratory in Costa Mesa, CA, specializes in routine QC/compendial testing, method development, and validation/verification services for companies across the Food & Beverage, Cosmetics and Dietary Supplements markets. Alkemist Labs is a leading laboratory that provides quality lab services and exceptional data integrity for NutriGold and companies like us in the Natural Products industry.
We began working with Alkemist in 2013 when it became apparent to us that we needed the services of a lab that understood and appreciated the importance of testing both raw materials and finished products for identity and analytical assay of marker compounds using reliable and valid methods. Alkemist has been especially great about their willingness to help validate vendor methods of analyses for particularly challenging raw materials and finished product matrices, and we rely on their experience and expertise to ensure that our products consistently meet our stringent quality standards.
Covance has over 75 years of expertise in the fields of clinical research, drug development, and nutritional chemistry. Covance’s standing in the industry as a trusted contract lab is powered by a global perspective, decades of experience servicing the analytical needs of supplement companies, and a team of 1,600 experts with the technical know-how to deliver reliable and valid results every single time.
Our decision to partner with Covance was based on their uncompromising commitment to ensuring dietary supplement quality and safety, their impressive portfolio of testing capabilities, and their willingness and ability to reliably validate vendor-supplied methods of analyses.
ChromaDex was established in 1999 in response to growing demand for natural product reference standards, materials, and services. In particular, ChromaDex develops and markets phytochemical and botanical reference standards and materials and brings safety and quality to the market with specialized analytical services backed by scientific rigor, experience, and expertise. ChromaDex’s ISO 17025 accreditation is a reflection of its ability to produce precise and accurate test and calibration data.
Our decision to work with ChromaDex is based on their experience and analytical savvy with respect to developing and validating test methods and coming up with innovative analytical solutions to even the most challenging testing matrices. We rely on ChromaDex to provide us with reliable and valid data that we use for vendor qualification, raw material selection, and finished product validation.
Silliker, the leading international network of accredited food testing and consulting laboratories, is dedicated to helping companies worldwide find practical solutions to today's food safety and quality challenges throughout the supply chain.
We work with Silliker because of their competencies in contaminant testing coupled with expert analysis of potency and overall quality. Silliker’s worldwide network of labs and testing analysts ensure that we have the resources we need to assay even the most challenging testing matrices and get results that are reliable and valid.
EMSL Analytical is a well-known network of laboratories that has been providing dietary supplement, food, environmental, cosmetic and contaminant testing services since 1981. EMSL Analytical is renowned for scientific accuracy and impeccable customer service. In addition, EMSL Analytical carries a wide range of accreditations and participates in numerous proficiency programs to ensure that the highest standard of quality is consistently met. Although allergen testing is not required by current GMPs, we have been testing our raw materials and finished products for allergens since 2011, because we are committed to ensuring that our products are safe for even the most vulnerable members of our population - the 15 million Americans who have known or suspected allergies to the 8 most common allergens.
We applaud NutriGold's commitment to allergen testing of their raw materials and finished products, especially considering neither allergen testing nor allergen labeling is currently required for dietary supplements by GMPs or the FDA. EMSL is honored to be a trusted analytical partner of NutriGold, Inc and work with them to ensure that their stringent quality standards and requirements are met with accuracy and confidence.
- Deepa Thakar, National Food Technical Sales Manager
Independent, Third-Party Certifying Organizations
The International Fish Oil Standards (IFOS) Program is the only third-party testing and certification program exclusively for fish oils. Offered by Nutrasource Diagnostics, participation in certification program is voluntary and allows participants to submit their fish oil supplements to ensure compliance with unparalleled purity, potency, freshness, and overall quality standards.
Our participation in the IFOS Program began when we launched our first Omega-3 product, the Triple Strength Omega-3 GOLD, back in 2011. Since then, we have had every lot of our Omega-3 products tested to ensure that it meets IFOS program’s stringent quality standards for purity, potency, and freshness. We know that consumers rely on the trusted IFOS ratings to help them make informed decisions about the fish oil products that are right for them and are proud to partner with a lab that is as committed to quality and transparency as we are.
The International Krill Oil Standards (IKOS) is a third-party testing and certification program for krill oil products performed by the expert analysts at Nutrasource Diagnostics, Inc. This program is voluntary and open to dietary supplement companies that wish to subject their krill oil products to rigorous quality testing for comparison to industry leading quality standards.
Our decision to participate in IKOS testing was in keeping with our commitment to third-party testing and validation of our products and inspired by consumer excitement over the transparency afforded by our participation in the IKOS Program. Not only are we one of only two companies that participate in the IKOS program, but we are the ONLY company that tests every lot of our Krill oil products for compliance with the program’s stringent standards for purity, potency, and freshness.
ConsumerLab.com is the leading provider of independent test results and information to help consumers and healthcare professionals identify the best quality health and nutrition products. It publishes results of its tests in comprehensive reports at www.consumerlab.com. CL also conducts an annual Survey of Vitamin & Supplement Users, and CL’s research is cited frequently by the media, in books, and at professional meetings. In addition to the products it selects to review, CL enables companies of all sizes to have their products quality tested for potential inclusion in its list of Approved Quality products and bear the CL Seal. Since its founding in 1999, CL has tested more than 3,400 products, representing over 450 different brands and nearly every type of popular supplement for adults, children, and pets.
LabDoor.com is an independent provider of third-party test results so consumers can better understand the products they entrust with their health. LabDoor.com uses the services of FDA registered, accredited analytical laboratories that have been qualified and selected by LabDoor.com based on their expertise in food, supplement, OTC, and pharmaceutical analyses. Summaries of test results are available for review online on LabDoor.com, but a subscription is required for viewing in-depth analytical reports
The Non-GMO Project is a non-profit organization which was started with the vision that everyone should have access to information that will help them make informed choices with regard to whether or not to consume GMOs (genetically modified organisms). As North America’s premier third-party verification and labeling for non-GMO food and products, the Non-GMO Project’s goal is to preserve and build sources of non-GMO products, educate consumers, and provide verified non-GMO choices. Currently, there are over 20,000 Non-GMO Project Verified products from 2,200 brands, representing well over $7 Billion in annual sales. Non-GMO Project Verified is currently one of the fastest growing labels in the natural food sector and is increasingly an attribute sought by conventional brands as well.
Genetic-ID is the first commercial laboratory in North America to provide DNA-based analysis of GMOs. With its global network of laboratories and active participation in national and international trials and performance assessment programs, Genetic-ID sets the standard for excellence, reliability, and consistency in the genetic detection of GMOs.
We began working with Genetic-ID back in 2011 when we first learned that the Non-GMO Project does not have standards in place for verifying softgels as being free of GMOs. Thanks to Genetic-ID’s cutting-edge DNA-based analysis, we are able to test and verify all of our softgel products as being free of GMOs, which is just one of the many value-added benefits we take pride in offering our customers.
Genetic ID is proud to be the third-party GMO testing laboratory of choice for NutriGold, Inc. We have been routinely testing NutriGold’s finished softgel products (e.g. Omega-3, CoQ10, Vitamin D3, Krill Oil) to verify the absence of GMOs using qualitative and quantitative PCR analysis since 2011, when they first launched their line of softgel products. - Alex Moreno, Director of Business Development