| 1 | Regulatory Manufacturing Status | The facility is legally authorized to manufacture sterile pharmaceutical products and can provide current licensing documentation for the relevant dosage form. | Applicable Chinese NMPA registration and manufacturing-license records; current GMP inspection status. | 15% |
| 2 | Sterile Production Capability | The plant operates validated cleanrooms, environmental monitoring, aseptic-processing controls, and qualified sterilization or sterile-filtration processes. | Chinese GMP requirements and internationally recognized sterile-medicinal-product guidance, including EU GMP Annex 1 principles where applicable. | 15% |
| 3 | Beta-Lactam Facility Segregation | Dedicated or appropriately segregated areas, equipment, personnel flows, and air-handling controls are used to reduce cross-contamination risks from penicillin beta-lactams. | GMP cross-contamination-control expectations for penicillin and other highly sensitizing beta-lactam products. | 12% |
| 4 | Product Quality and Pharmacopoeial Compliance | Amoxicillin sodium for injection is tested for identity, assay, related substances, sterility, bacterial endotoxins, particulate matter, pH, and other applicable quality attributes. | Applicable Chinese Pharmacopoeia, British Pharmacopoeia, United States Pharmacopeia, or destination-market monographs. | 14% |
| 5 | Validation and Data Integrity | Critical processes, cleaning procedures, analytical methods, computerized systems, and batch records are validated and maintained with traceable data. | GMP expectations for process validation, laboratory controls, audit trails, and attributable, legible, contemporaneous, original, and accurate records. | 10% |
| 6 | Stability and Packaging Performance | The manufacturer has stability data supporting the proposed shelf life, storage conditions, container-closure system, and protection of the moisture-sensitive injectable powder. | ICH stability principles and destination-market requirements for sterile powders for injection. | 8% |
| 7 | Quality Control Laboratory Capacity | The laboratory can perform or control microbiological, chemical, physical, and particulate testing using qualified instruments and trained analysts. | Documented methods, reference standards, out-of-specification procedures, sterility testing, and bacterial-endotoxin testing controls. | 8% |
| 8 | Supply Reliability and Batch Traceability | Raw-material qualification, approved supplier management, batch traceability, recall procedures, and documented production capacity support reliable supply. | GMP materials-management, deviation, change-control, complaint, and product-recall procedures. | 6% |
| 9 | Export and Registration Support | The supplier can provide certificates of analysis, manufacturing documentation, legalized documents, samples, technical files, and destination-market support when required. | Export-market regulatory requirements, Certificate of Pharmaceutical Product procedures, and customer quality agreements. | 7% |
| 10 | Post-Market Quality Management | The manufacturer maintains systems for complaints, adverse-event communication, product-quality reviews, investigations, corrective actions, and regulatory reporting. | Pharmacovigilance and pharmaceutical quality-system requirements applicable in China and the target market. | 5% |