| 1 | Manufacturing Quality System | A documented quality management system supported by current GMP controls. For dietary supplements sold in the United States, compliance with 21 CFR Part 111 is relevant. | Current GMP certificate, quality manual, audit history, deviation records, CAPA procedures, and change-control records. | 20% | Critical |
| 2 | Food Safety Management | HACCP-based preventive controls and, preferably, certification to an internationally recognized food-safety scheme such as ISO 22000 or FSSC 22000. | Valid certificate, HACCP plan, hazard analysis, allergen-control program, sanitation records, and environmental-monitoring procedures. | 12% | Critical |
| 3 | Identity and Assay Testing | Each lot should be tested against a written L-glutamine specification. HPLC or another scientifically validated chromatographic method is commonly used for identity and assay evaluation. | Lot-specific certificate of analysis, validated method summary, reference standard information, assay result, and acceptance criteria. | 18% | Critical |
| 4 | Microbiological Quality | Testing should address total aerobic microbial count, total yeast and mold count, and specified pathogens according to the destination market and product category. | Recent lot-specific results, test methods, laboratory accreditation details, and documented limits for organisms such as Salmonella and Escherichia coli. | 12% | Critical |
| 5 | Heavy-Metal Control | Lead, arsenic, cadmium, and mercury should be assessed using a suitable validated technique, commonly ICP-MS or ICP-OES. Limits must match the applicable regulation. | Recent heavy-metal test report, method detection limits, laboratory qualification, and comparison with the target-market requirements. | 8% | Critical |
| 6 | Contaminant and Adulteration Screening | The risk-based program should consider residual solvents, unusual impurities, undeclared substances, and process-specific contaminants. | Risk assessment, impurity profile, residual-solvent results where applicable, authenticity controls, and investigation procedures for atypical results. | 8% | High |
| 7 | Specification and COA Transparency | The specification should define appearance, identification, assay, impurities, moisture or loss on drying, microbiological limits, packaging, and storage conditions. | Signed lot-specific COA, approved specification, test dates, batch number, retest or expiry date, and clear pass/fail statements. | 10% | High |
| 8 | Stability and Shelf Life | Shelf life should be supported by stability data under defined packaging and storage conditions. Drug-grade materials may require formal ICH-aligned stability studies where applicable. | Stability protocol, time-point results, packaging configuration, recommended storage conditions, and rationale for the assigned shelf life. | 7% | High |
| 9 | Traceability and Recall Readiness | Raw materials, production records, packaging components, test results, and distribution records should be traceable by lot. | Mock-recall results, batch genealogy, retention-sample policy, complaint handling, and documented recall procedures. | 3% | High |
| 10 | Independent Laboratory Verification | Periodic confirmation testing by a qualified independent laboratory improves confidence in identity, assay, contaminants, and microbiological results. | Independent test reports, laboratory accreditation status, chain-of-custody records, sampling plan, and resolution of any conflicting result. | 2% | Recommended |