| Botanical Identity | Correctly identified as bilberry, Vaccinium myrtillus L.; the plant part and extract type must match the product specification. | Macroscopic or microscopic examination, botanical reference comparison, and chromatographic fingerprinting such as HPLC or HPTLC. | Authenticated raw-material report, botanical identification procedure, and laboratory test results. | 15% |
| Anthocyanin Content | A clearly defined minimum percentage of total anthocyanins, expressed using a stated reference standard and analytical method. The value must be consistent with the commercial specification. | Validated HPLC analysis is preferred for individual anthocyanins; spectrophotometric methods may be used when the calculation and reference standard are clearly stated. | Certificate of analysis with batch number, test method, reference standard, result, and specification limits. | 15% |
| Raw-Material Traceability | Traceability from growing or collection area through harvesting, extraction, drying, packaging, and shipment. | Document review and mock recall or lot-tracing exercise. | Lot coding system, source records, harvest documentation, processing records, and recall procedure. | 10% |
| Pesticide Residues | Compliant with the maximum residue limits applicable in the target market. For EU food and botanical products, applicable Regulation (EC) No 396/2005 limits should be checked. | Multi-residue GC-MS/MS and LC-MS/MS testing by a competent laboratory. | Recent batch-specific pesticide report covering the relevant analyte list and reporting limits. | 10% |
| Heavy Metals | Lead, cadmium, mercury, and arsenic must comply with the legal limits or product-specific limits in the destination market. Inorganic arsenic should be reported separately where relevant. | ICP-MS or another validated elemental-analysis method. | Laboratory report identifying each element, units, detection limits, and applicable specification. | 8% |
| Microbiological Quality | Total aerobic microbial count, yeast and mold, Escherichia coli, Salmonella, and other relevant organisms must meet the limits specified for the intended dosage form and market. | Validated pharmacopeial or food-microbiology methods, depending on intended use. | Batch microbiology report, sampling plan, and environmental-monitoring summary when applicable. | 10% |
| Residual Solvents | Residual solvents must comply with ICH Q3C requirements or the applicable local regulatory standard. Water and ethanol extraction generally reduce solvent-risk concerns. | Headspace gas chromatography with a validated method. | Extraction-process declaration and residual-solvent test report when organic solvents are used. | 6% |
| Moisture and Physical Properties | Moisture, appearance, color, odor, particle size, bulk density, and solubility should remain within agreed product-specification ranges. | Loss-on-drying or Karl Fischer testing, visual inspection, and standardized physical tests. | Approved specification, batch test results, packaging requirements, and storage instructions. | 6% |
| Contaminant and Adulteration Control | No undeclared fillers, synthetic colorants, unauthorized preservatives, or substitution with other Vaccinium species. | Chromatographic fingerprinting, microscopy, DNA-based testing where suitable, and targeted adulterant screening. | Food-fraud vulnerability assessment, authenticity program, and independent test results. | 8% |
| Quality Management System | Documented GMP, HACCP, or equivalent controls appropriate to the product category and destination market. | Certification review, supplier questionnaire, and risk-based on-site or remote audit. | Valid certificates, audit reports, corrective-action records, SOP index, and change-control procedure. | 7% |
| Stability and Shelf Life | Shelf life must be supported by stability data demonstrating that anthocyanin content and microbiological quality remain within specification under defined conditions. | Real-time and, where appropriate, accelerated stability studies in the final packaging. | Stability protocol, time-point results, retest date, storage conditions, and packaging qualification. | 5% |