Manufacturing Quality Systems Audit
Stage 1: Product/Ingredient Assessment Review
A full review of the quality systems in place at the product manufacturing facility is undertaken. This is carried out initially via a paper/electronic audit, and physical audits are also performed where needed for sports inspected facilities (Informed-Choice registered site). The aim of this audit is to ensure that the facility follows good manufacturing practices. The audit assists in filling gap between where standard good manufacturing practice requirements, and sports anti-doping practices. The ultimate objective is to ensure that preventative measures are in place to minimize contamination of a product/ingredient with a prohibited substance.
The Product 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. 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 analyzed for traces of prohibited substances.
Manufacturing facilities also have the option of have swabs taken at their facility to provide assurance that their critical control procedures are adequate for the manufacturing of sports nutrition products.
The Product/Ingredient Assessment is carried out by trained staff at LGC, a world class sports anti-doping laboratory. LGC 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. LGC 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 LGC's analysis of over 50,000 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. LGC also has considerable expertise in quality control procedures and working within the requirements of internationally recognized quality systems.
It should be noted that the Product 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.
- 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