Reputable raw material suppliers and manufacturers of sports nutrition products can register their site with INFORMED-CHOICE in order to help companies easily identify them as having appropriate quality systems in place.
Registration of a manufacturing site or raw material (RM) facility with INFORMED-CHOICE involves 3 stages:
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Stage 1: Site Assessment 
A full review of the quality systems in place at the facility is undertaken. This is carried out via a paper/electronic audit as well as a physical audit.
The Site Assessment involves:
- Raw Material (RM) Evaluation at Each Production/Packing Site
- Raw Material Supplier Assessment Procedures
- Certificate and SOP Review for all Production/Packing/Storage Areas
Stage 2: Pre-Registration Swab/Sample Testing
During the Site Assessment Process, a number of swabs/samples are collected from various critical control points. These swabs/samples are tested at HFL to ensure that there is no indication of contamination issues with prohibited substances at the site.
Initially, a minimum of 20 swabs/samples are collected and tested. Analysis time is typically 6 working days from receipt at the lab, and results will be reported to the prospective member via a Certificate of Analysis.
Stage 3: Post-Registration Requirements
Once Stages 1 and 2 are complete, and the requirements of INFORMED-CHOICE have been met, the site will be accepted for registration with INFORMED-CHOICE. A license agreement will be issued, which enables the new member company to use the INFORMED-CHOICE logo in association with the registered site. The registered site will be listed on the INFORMED-CHOICE.org website, along with a link to the member company's website.
Post-Registration Site Visits and Testing
Once registered, the member company will be physically audited every 6 months to ensure that compliance with the INFORMED-CHOICE program is maintained. These on-site visits involve a review of procedures being followed, as well as checks to ensure that any changes in procedure have been captured and assessed. Further swabs/samples are collected during the 6-monthly audit. These are analyzed at HFL to ensure there is no indication of trace contamination with prohibited substances at the site. A minimum of 10 swabs/samples are collected during the 6-monthly site visits.
Stage 1: Site Assessment
A full review of the quality systems in place at the facility is undertaken. This is carried out via a paper audit as well as a physical audit. The aim of this pre-registration audit is to ensure that the facility follows good manufacturing practices. Particular attention is made to fill the "gap" between where standard good manufacturing practice requirements end, and sports anti-doping practices begin. The ultimate objective is to ensure that preventative measures are in place to minimize contamination of a product/ingredient with a prohibited substance.
The Site Assessment involves a review of certificates of accreditation held by the facility, a thorough review of standard operating procedures in place at the facility, a full review of all raw materials handled on site and assessment of likely risks with respect to prohibited substance contamination, etc
During the review any remedial actions are discussed with the company wishing to register its site. Once these remedial actions have been addressed the registration process can proceed.
Assessment Details
The Site Assessment is carried out by trained staff at HFL Sport Science, a world class sports anti-doping laboratory. HFL has over 47 years of expertise in anti-doping in sport and has published over 300 scientific papers on methods it has developed for the detection of trace levels of substances that are prohibited in sport. HFL has over 450 man-years of research into sports doping control.
The information provided by the prospective member during the Site Assessment is assessed against knowledge and intelligence gained from HFL's analysis of over 20,000 supplement/ingredient samples for prohibited substances over the past 8 years, as well as the expertise gained from working in the sports anti-doping community. HFL also has considerable expertise in quality control procedures and of working within the requirements of internationally recognized quality systems.
The Site Assessment involves a thorough audit of the quality systems in place at the facility. An initial paper/electronic audit is carried out, focusing on Standard Operating Procedures (SOPs) in place at the facility. This paper audit is followed by a physical site audit during which the SOPs are further reviewed with the prospective member and swabs/samples are collected from various critical control points at the site (see Stage 2).
Note: The Site Assessment is not designed to replace good manufacturing practice (or equivalent) audits. Instead, it is designed to sit alongside the quality systems (such as GMPs) that are already in place at the facility, bridging the gap between where standard good manufacturing practices end, and where sports doping control requirements begin.
The Site Assessment involves:
Raw Material (RM) Evaluation
- Review of all RM handled at the facility, including assessment of any ingredients that may be considered prohibited in sport or that pose a contamination risk, this includes potential prohibited RM that may have previously been handled at the facility
- Review raw material testing records
- Review of Standard Operating Procedures (SOPs) for RM storage and handling
Raw Material Supplier Assessment Procedures
- Review documentation on RM supplier selection and qualification
- Review quality standards used to qualify supplier or broker
- Review where RM are sourced from
- Review understanding/knowledge of RM suppliers regarding prohibited substance testing and contamination risks
Certificate and SOP Review for all Production/Packing/Storage Areas
- Review of Certificates obtained from qualified 3rd party auditors for Good Manufacturing Practice (GMP) or similar standards
- Review other accreditations and certificates held by the site; check ongoing audit and renewal frequency
- Review SOPs at the facility, including cleaning SOPs, staff training/hygiene practices, RM handling SOPs, traceability/recall SOPs, CAPA processes, procedures for retained samples, etc.
- Review production records and internal quality systems
- Review of equipment used at the facility
