| Good Manufacturing Practice | GMP requirements applicable to dietary supplements, food ingredients, or pharmaceutical materials, depending on the intended use | The manufacturing site should operate documented procedures for personnel hygiene, production controls, equipment sanitation, deviation handling, and batch release. | Current GMP certificate, recent audit report, quality manual, corrective-action records, and manufacturing-site information | Essential |
| Food Safety Management | HACCP principles and, where applicable, ISO 22000 or an equivalent food-safety management system | The supplier should identify biological, chemical, and physical hazards and maintain preventive controls from raw-material receipt through packaging. | HACCP plan, hazard analysis, food-safety certificate, monitoring records, and internal-audit results | Essential |
| Quality Management System | ISO 9001 or an equivalent documented quality-management system | Quality responsibilities, document control, complaint handling, supplier qualification, change control, and continual-improvement procedures should be clearly defined. | Quality certificate, organization chart, standard operating procedures, complaint log summary, and change-control procedure | Recommended |
| Botanical Identity | Pharmacopoeial or validated botanical identification methods, including macroscopic, microscopic, chromatographic, or DNA-based methods where appropriate | The supplier should verify the correct Panax species, plant part, geographical origin, and raw-material identity before extraction. | Certificate of Analysis, botanical identification report, raw-material specification, voucher or reference sample information, and supplier approval records | Essential |
| Ginsenoside Profile | Validated HPLC or equivalent chromatographic testing for characteristic ginsenosides | Every commercial batch should be tested against a written specification for total ginsenosides and, when relevant, individual markers such as Rb1, Rg1, and Re. | Batch-specific HPLC report, analytical method, reference-standard information, chromatograms, and acceptance limits | Essential |
| Assay and Batch Consistency | Customer-approved product specification and validated analytical methods | Results should remain within agreed limits for extract ratio, moisture, physical characteristics, and declared active-marker content across production batches. | Three or more recent batch Certificates of Analysis, specification sheet, batch records, and trend-analysis data | Essential |
| Contaminant Control | Applicable food, supplement, or pharmaceutical contaminant limits in the destination market | Testing should cover heavy metals, pesticide residues, microbial contamination, mycotoxins where relevant, residual solvents, and other market-specific contaminants. | Independent laboratory reports, contaminant limits, test methods, sampling plan, and results linked to the specific batch | Essential |
| Microbiological Safety | Applicable microbiological criteria for the product category and intended market | The supplier should specify limits for total aerobic microbial count, yeast and mold, and relevant pathogens such as Salmonella and Escherichia coli. | Batch microbiology report, laboratory accreditation details, environmental-monitoring summary, and sanitation records | Essential |
| Residual Solvent Control | ICH Q3C principles or equivalent national requirements when organic solvents are used during extraction | The extraction process should use a declared solvent system, and residual solvents should be controlled within applicable limits or shown to be absent when relevant. | Extraction-process description, residual-solvent test report, solvent specification, and process-validation summary | Recommended |
| Traceability | Documented one-step-back and one-step-forward traceability principles | Each batch should be traceable to the farm or raw-material supplier, harvest information, extraction record, packaging lot, and shipment documentation. | Lot-number system, traceability map, raw-material records, batch manufacturing record, and mock-recall results | Essential |
| Raw-Material Supply Chain | Approved-supplier program and agricultural or collection controls appropriate to the botanical material | The supplier should control species authenticity, cultivation or collection practices, harvest date, drying conditions, storage, and potential adulteration risks. | Raw-material specification, approved-supplier list, cultivation or collection records, origin statement, and incoming inspection results | Essential |
| Adulteration and Substitution Prevention | Risk-based botanical authentication and economically motivated adulteration controls | The supplier should assess the risk of substitution with other Panax species, undeclared fillers, synthetic marker compounds, or non-ginseng plant material. | Adulteration-risk assessment, identity-testing protocol, reference standards, and periodic independent verification | Advanced |
| Stability and Shelf Life | Documented stability protocol suitable for the extract format and packaging system | The supplier should establish storage conditions and a justified shelf life using stability data that monitor marker content, moisture, microbiology, and physical appearance. | Stability study report, retest-date policy, storage specification, packaging specification, and retained-sample program | Recommended |
| Packaging and Storage | Good storage and distribution practices appropriate for botanical extracts | Packaging should protect the extract from moisture, light, oxygen, contamination, and damage during transport; warehouse conditions should be monitored and recorded. | Packaging material specification, warehouse temperature and humidity records, transport conditions, and label samples | Essential |
| Independent Laboratory Verification | Testing by a competent laboratory; ISO/IEC 17025 accreditation is a strong indicator of laboratory competence | Critical identity, potency, and contaminant results should be confirmed periodically by an independent laboratory rather than relying only on in-house testing. | Independent test reports, laboratory scope of accreditation, method validation summary, and sample-chain records | Recommended |
| Regulatory and Export Documentation | Requirements of the importing country and the product’s intended regulatory category | The supplier should provide accurate ingredient declarations, allergen statements, non-GMO or organic documentation when claimed, safety data, and export documents where required. | Technical data sheet, Safety Data Sheet where applicable, allergen statement, country-of-origin statement, product label information, and export certificates | Essential |
| Change Control and Notification | Documented pharmaceutical, food, or supplement quality-system change-control practices | The supplier should notify customers before significant changes to species, origin, extraction solvent, manufacturing site, specifications, analytical methods, or packaging. | Change-control procedure, notification policy, historical change records, and revised specification approval process | Recommended |
| Customer Complaint and Recall Readiness | Documented complaint investigation, product withdrawal, and recall procedures | The supplier should investigate complaints using root-cause analysis and demonstrate the ability to identify and withdraw affected batches within a defined timeframe. | Complaint procedure, recall plan, mock-recall record, investigation template, and corrective-action report | Essential |
| Technical Capability and Customization | Validated process capability and customer-approved specifications | The supplier should be able to control extract ratio, powder or liquid format, carrier content, solubility, standardization level, and application-specific performance. | Technical data sheet, pilot-batch results, process-flow diagram, development samples, and performance-testing data | Recommended |