| GMP system and quality responsibility | Documented quality management practices, defined responsibilities, and management oversight | Quality manual, organization chart, quality policy, management review records | Written procedures are current, approved, controlled, and implemented by assigned personnel | High | 15% |
| Personnel competence and hygiene | Training, personal hygiene, protective clothing, and health controls | Training matrix, competency assessments, hygiene procedures, training records | Employees performing production and quality tasks receive documented initial and ongoing training | High | 10% |
| Premises and contamination control | Suitable layout, cleanliness, sanitation, pest control, and prevention of mix-ups or contamination | Site photographs or audit access, cleaning schedules, sanitation records, pest-control logs | Production and storage areas are clean, maintained, appropriately separated, and protected from contamination | High | 12% |
| Equipment qualification and maintenance | Equipment suitability, cleaning, calibration, maintenance, and prevention of product contamination | Equipment list, cleaning records, maintenance logs, calibration certificates | Equipment is suitable for the formulation and has traceable maintenance and calibration where applicable | High | 10% |
| Raw material and packaging control | Receipt, identification, sampling, testing, release, storage, and traceability | Approved supplier list, specifications, certificates of analysis, incoming inspection records | Materials remain identifiable and are released by quality personnel before use | Critical | 15% |
| Formula and production controls | Master formula, weighing, processing instructions, batch documentation, and in-process controls | Master manufacturing record, sample batch record, weighing logs, process parameters | Each batch is produced according to an approved formula with complete and reviewable records | Critical | 15% |
| Microbiological and quality testing | Quality-control testing, laboratory practices, sampling, and handling of test results | Finished-product specifications, test methods, microbial test reports, laboratory qualification records | Finished eyelash serum is tested against approved specifications before release, including applicable microbiological criteria | Critical | 15% |
| Preservation and packaging compatibility | Product protection, packaging suitability, storage conditions, and contamination prevention | Stability data, preservative-challenge results where applicable, packaging specifications, compatibility studies | The formula and package are supported by documented stability and compatibility evidence appropriate to the product | High | 10% |
| Deviations, CAPA, and change control | Investigation of departures from procedures, corrective actions, preventive actions, and controlled changes | Deviation forms, root-cause investigations, CAPA records, change-control procedure | Significant deviations are investigated, documented, approved, and closed with effectiveness checks when needed | High | 8% |
| Complaints, traceability, and recall readiness | Complaint handling, batch traceability, market feedback, and recall procedures | Complaint SOP, traceability exercise, mock-recall record, distribution records | The supplier can trace raw materials and finished goods by batch and has a documented recall process | Critical | 10% |
| Internal audits and supplier oversight | Routine self-inspection and control of outsourced activities and material suppliers | Internal-audit schedule, completed audit reports, subcontractor qualification records | Audits are planned, documented, risk-based, and followed by corrective-action tracking | Medium | 5% |
| Document and data integrity | Controlled procedures, record retention, approval, version control, and legible production records | Document-control SOP, controlled-record samples, retention schedule, electronic-system controls | Records are attributable, contemporaneous, accurate, complete, consistent, and protected from unauthorized alteration | Critical | 10% |