For contract manufacturers of sports and dietary supplements, the risk of contamination with low levels of substances prohibited by the World Anti-Doping Agency (WADA) is a serious issue. The Informed Manufacturer programme was created by LGC, and is a member of the INFORMED family of certification programmes, globally recognised in quality assurance and testing of sports and dietary nutrition products, ingredients and facilities. It enables manufacturers to optimise quality control procedures to reduce the risk of banned substance contamination within the facility.
Through years of research and analysis of more than 50,000 supplements, LGC has identified that standard quality control practices may not be enough to stop cross-contamination with low levels of substances prohibited in sport. LGC’s expertise allows facilities to minimise the risk of cross-contamination occurring within manufacturing processes through a combination of facility testing and assessment.
Informed Manufacturer is a unique certification that provides in-depth analysis into critical control processes. Through regular on-site assessments and manufacturing facility swabbing, Informed Manufacturer helps those who produce and supply supplement products identify and resolve areas of risk within the manufacturing process.
A full review of the procedures in place at the facility is undertaken via a paper-based assessment. This process is managed by experienced assessors, who provide guidance on how to meet the required standards of the Informed Manufacturer programme and reduce risk within manufacturing processes.
This stage of the certification includes an assessment of the following:
An Informed Manufacturer Assessor will visit the site to both review practices at the site and take approximately 20 swabs from various critical control points for analysis. These swabs are tested at LGC for a wide range of prohibited substances using ISO/IEC 17025 accredited methods. Informed Manufacturer will provide a written report following the pre-certification site visit detailing the outcome of the visit and any associated actions and/or observations.
Once Stages 1 and 2 are complete and any resulting actions have been closed out, the site will be accepted for certification with Informed Manufacturer. A certificate will be issued, after which time the new Member company may use the Informed Manufacturer logo in association with the certified site. The Member company will be provided with the ‘Informed Manufacturer Brand Standards’ which explains how the logo may be used and how best to market the new certification mark. The certified site will be listed on the Informed Manufacturer website with a profile of their facility and production capabilities.
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.
Approximately 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.