Stage 1: Product/Ingredient Assessment Review 

A full review of the quality systems in place at the product/ingredient manufacturing facility is undertaken. This is carried out initially via a paper/electronic audit, and physical audits are also performed where needed. The aim of this audit is to ensure that the facility follows good manufacturing practices. In addition, particular attention is aimed at filling 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 minimise contamination of a product/ingredient with a prohibited substance.

The Product/Ingredient Assessment involves a review of certificates of accreditation held by the facility, a thorough review of standard operating procedures in place at the manufacturing/packing facility, label checks on the product, review of all raw materials handled at the manufacturing/packing 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 product/ingredient. Once these remedial actions have been addressed the registration process can proceed.

If any issues arise from the manufacturing review that requires further detailed assessment, an on-site audit will be performed to assess procedures at the facility. The on-site audit will include collection of swabs from various parts of the facility. These swabs will be analysed for traces of prohibited substances.

Assessment Details

The Product/Ingredient Assessment is carried out by trained staff at HFL Sport Science, a world class sports anti-doping laboratory. HFL has over 50 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 Product/Ingredient Assessment is assessed against knowledge and intelligence gained from HFL's analysis of over 35,000 supplement/ingredient samples for prohibited substances over the past 10 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 working within the requirements of internationally recognized quality systems.

The Product/Ingredient Assessment is a thorough audit of the quality systems in place at the manufacturing/packing facility. This audit is backed up by pre-registration testing of the product/ingredient that is being considered for registration (Stage 2). The Product/Ingredient Assessment is also reinforced by a physical site audit where this is considered necessary.

It should be noted that the Product/Ingredient Assessment is not designed to replace good manufacturing practice (or equivalent) audits. Instead, it is designed to sit alongside the quality systems (such as GMP’s) 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.

(Note: Some companies use multiple sites to make their products/ingredients; each site undergoes the same checks as part of the registration process. This includes any outsourced packing/storage facilities.)

Product/Ingredient Evaluation

• Product formulation/ingredient review
• Label review (claims, nutritional labeling, thorough check of ingredients used)
• Product variances review (e.g. flavors, container sizes)
• Batch/lot size check
• Product shelf life check

Raw Material (RM) Evaluation at Each Production/Packing Site 

• Review of all RM handled at the manufacturing/packing 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 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 homogeneity tests
• Review of equipment used at the facility

Label Claim, Purity and Contaminant Testing Review

• Review previous nutritional label and contamination testing and frequency of ongoing label/purity testing
• Review any previous compliance issues with prohibited substance contamination, contamination with other harmful contaminants, failed nutritional label tests, etc

Third Party Manufacturer (TPM)

• Review TPM selection and qualification procedures
• Review of SOPs and procedures as outlined above for Production/Packing/Storage areas
• Review awareness and understanding of TPM with regard to prohibited substance testing and contamination risk

Stage 2: Pre-Registration Sample Testing

The manufacturer will submit 5 samples of each product/ingredient to be registered to HFL Sport Science for testing using its nutritional supplement screen. HFL has been analysing supplements/ingredients for over 10 years, and has tested over 35,000 samples to date. HFL's supplement screen includes ISO 17025 accredited tests for prohibited substances in all formulation types (tablets, bars, powders, capsules, liquids, gels). All testing is performed in its ISO 17025 accredited lab. See Testing Specification for more detail.

The pre-registration samples will be tested in parallel with the Product/Ingredient Assessment being performed. Analysis time for the testing is typically 6 working days from receipt at the lab, and results will be reported to the prospective member via a Certificate of Analysis. This is sent initially by email and the original copy is sent by post.

For the purpose of product/ingredient registration, if more than 1 variant of the product/ingredient exists, this will be counted as a single product. For example, if the product to be registered is a whey powder that is available in 3 different flavors, the pre-registration testing would comprise 3 samples from 1 flavor, and 1 sample from each of the two remaining flavors (i.e. we would not need to test 5 samples of each flavor).

Post-Registration Batch Testing

Once registered, ongoing batch testing and blind sample testing is carried out by HFL each month to ensure the products carrying the INFORMED-SPORT seal are part of a regular screening programme.

For a registered ingredient, the member company will submit samples from batches that are to be used in sports nutrition products. Each sample should be submitted in 2 containers — one for testing (the "A" sample) and the other for retention in secure storage (the "B" sample). This procedure is common in sports doping control and enables further analysis to be performed if needed (e.g. in the event that an allegation is made against the product/ ingredient).

The "A" sample will undergo testing using HFL's nutritional supplement screen to ensure that compliance with the INFORMED-SPORT programme is maintained. Each tested batch will be listed on the INFORMED-SPORT.com website.

"Blind" Sampling

From time to time, INFORMED-SPORT will independently purchase and test a sample of the registered product. This provides an independent integrity check, and ensures compliance is maintained.