Informed Manufacturer is a global quality assurance programme developed to help minimise the risk of banned substance contamination within facilities that manufacture and supply sports nutrition products and ingredients.
Reputable manufacturers and suppliers of sports nutrition products and ingredients are able to certify their site within the Informed Manufacturer programme so sports nutrition brands can easily identify them as having quality systems in place to limit the likelihood of inadvertent contamination. This ensures the integrity of the manufacturing process specifically for the sports nutrition manufacturing practices.
Sites carrying the Informed Manufacturer logo are tested regularly for banned substances using ISO/IEC 17025 accredited methods. Facilities are screened for banned substances to part-per-billion levels of accuracy, using a robust swabbing and testing process. In addition, manufacturing sites must meet strict quality control standards.
The Informed Manufacturer certification process consists of 4 stages:
For an in-depth description of all four stages, please visit our certification process page.
LGC is accredited to ISO/IEC 17025, a globally recognised standard relating to laboratories and test procedures. LGC holds accreditation for a broad range of analytical testing, including the analysis of nutritional supplements for banned substances. LGC has held accreditation for supplement analysis since 2003 and is frequently inspected by the accreditation bodies UKAS (the United Kingdom Accreditation Service - LGC laboratory number 1187) and A2LA (the American Association for Laboratory Accreditation - LGC certificate no. 3244.01). During inspections, analytical methodology and validation data are independently assessed by a third-party auditor/expert, providing confidence to brands and consumers alike that methodology and analytical procedures meet some of the most stringent certification standards possible.
ISO/IEC 17025 accreditation is critical for any laboratory, in that it shows that test procedures have been independently assessed/evaluated objectively by third-party industry experts. LGC has held ISO/IEC 17025 accreditation for supplement analysis since 2003.
Independent audits ensure that test methodology and validation data are "fit for purpose" for each individual test.
LGC has been testing supplement products for prohibited substances since 2002 and has tested tens of thousands of product/ingredient samples during that time. LGC currently tests over 20,000 samples per year for more than 600 companies worldwide.
LGC's testing capability for supplements includes the analysis of over 250 substances that are prohibited in sport and substances that pose a threat in respect to product contamination. These substances include the drugs of abuse, anabolic agents, stimulants, beta-2-agnostics, masking agents, diuretics, and new and emerging threats such as SARM's, vaptans, and PPAR's, etc.
LGC has more than 55 years of experience as a regulatory doping control laboratory, testing both animal and human biological samples for the presence of substances prohibited in sport. Between 2004 and 2007, LGC (formerly HFL Sport Science) were accredited by WADA/IOC for the testing of athlete samples. However, in 2007 and following rising concerns from athletes regarding supplement contamination, LGC voluntarily withdrew this certification to focus efforts on the testing of supplement products for banned substances.
WADA accredited laboratories cannot commercially test supplement products for endorsement purposes - the following extract is taken from the WADA website:
WADA is not involved in any certification process regarding supplements and therefore does not certify or endorse manufacturers or their products. WADA does not control the quality or the claims of the supplements industry which may, from time to time, claim that their products have been approved or certified by WADA.
Our extensive experience as a sports anti-doping laboratory provides us with a unique understanding of the sports regulatory environment from a laboratory perspective.
At LGC, stringent quality control measures are adopted for each and every sample, to validate both analysis and extraction procedures. This provides brands and consumers alike with the assurance that test results are both robust and reliable. The analysis of such control samples also allows LGC to identify problematic and challenging sample matrices, where additional investigative work may be required - a growing requirement within the evolving supplement market. Where a laboratory does not have such exacting quality standards (as required by ISO/IEC 17025), such problems may be overlooked, resulting in the false reporting of an unsubstantiated result.
Unfortunately, no laboratory can test for all substances which would be considered prohibited in sport. This is also highlighted by the fact that even the WADA prohibited list is open-ended; using the wording "other substances with a similar chemical structure or similar biological effect(s) in specific sections of the list. There is no specific list defining all prohibited substances.
In addition, the WADA prohibited list is specifically focused on the analysis of human biological samples (e.g. urine, blood, etc.). As such, WADA laboratories will also be testing samples for a wide range of metabolites (i.e. the metabolic breakdown products of drugs). With respect to the analysis of supplement products, the analysis will typically focus on the presence of the parent drug.'
Although it is not possible to test for all substances on the WADA prohibited list, through its experience in testing over 150,000 samples and its close relationship with the anti-doping community, LGC has been able to develop an extensive screening programme to manage product integrity; addressing both historic and emerging threats within the supplements industry.
Approximately six months after certification, a surveillance site assessment will be performed which includes collection and testing of 10 swabs and a re-review of the site and manufacturing processes. Providing continued compliance is demonstrated, the Member company will then be subject to an assessment every 12 months, either remote or on-site, including collection and testing of 20 swabs alongside the facility review. Paper-based re-assessments are performed every six months.
Every three years, the certified site will be required to undertake a major re-assessment of the site and manufacturing processes via a Manufacturing Assessment Questionnaire. Assessments involve a review of procedures being followed, as well as checks to ensure that any changes in procedures have been captured and analysed to verify that compliance with the Informed Manufacturer programme is maintained.
For more information on certification, please visit the Informed Manufacturer Certification Process page.
Informed Manufacturer testing and certification applies only to facilities. It does not imply banned substance testing has been carried out on any finished product made in a certified facility and the logo may not be used by any third-party of the finished product. The Informed Manufacturer name can not be used to imply the quality of a finished product. Companies interested in having finished-product certification can learn more about our Informed Sport and Informed Choice programmes.
Informed Manufacturer certification is location specific, and multiple sites must be assessed and certified individually.
All sites certified by Informed Manufacturer are listed on the certified manufacturers page on the Informed Manufacturer website. Along with the website listing, a link to the certified manufacturer's website is listed as well as information provided by each site. Certified Manufacturers are also provided with a brand standards guide containing marketing recommendations.