| 1 | Pharmaceutical Quality-System Compliance | 18% | Documented pharmaceutical packaging quality controls aligned with ISO 15378, supported by a current quality-management system. | 18 points for verified ISO 15378 certification; 12 for ISO 9001 only; 0–8 for documented internal controls without third-party certification. |
| 2 | Glass Type and Chemical Durability | 15% | Use of Type I borosilicate glass when high hydrolytic resistance is required, with testing against recognized pharmacopeial requirements such as USP <660> or Ph. Eur. 3.2.1. | 15 points for Type I glass with batch test records; 10 for Type II; 6 for Type III; deduct points when test evidence is unavailable. |
| 3 | Dimensional Accuracy and Interchangeability | 12% | Controlled bottle height, diameter, neck finish, wall thickness, and mouth dimensions based on approved drawings and applicable neck-finish standards. | 12 points for documented inspection records and calibrated gauges; 6–10 points when only partial dimensional data is supplied. |
| 4 | Defect-Control and Inspection Capability | 12% | Inspection for cracks, stones, bubbles, blisters, cords, dirt, chips, cosmetic defects, and critical mouth or sealing defects. | 12 points for automated inspection combined with final human inspection; 7–10 points for manual or semi-automated inspection. |
| 5 | Sterilization, Depyrogenation, and Cleanliness Suitability | 10% | Clear supply options for washed, depyrogenated, or ready-to-use containers where required, with controlled packaging and cleanliness documentation. | 10 points for validated ready-to-use processing; 6 points for controlled washing; 3 points for standard non-cleaned supply. |
| 6 | Production Capacity and Delivery Reliability | 9% | Multiple forming lines, defined monthly capacity, documented production planning, and stable lead-time performance. | 9 points for verified capacity and delivery records; 5–7 points for stated capacity without historical evidence. |
| 7 | Traceability and Change Control | 8% | Lot identification, raw-material records, inspection reports, retention samples, complaint handling, and documented control of changes. | 8 points for full lot-level traceability and formal change notification; 4–6 points for partial traceability. |
| 8 | Customization and Tooling Capability | 6% | Ability to develop custom molds, neck finishes, colors, capacities, embossing, and drawings while maintaining controlled design revisions. | 6 points for in-house engineering and mold support; 3–5 points for outsourced or limited customization. |
| 9 | Packaging, Export, and Regulatory Documentation | 5% | Protective inner packaging, palletization, export documentation, certificates of analysis, material declarations, and safety data where applicable. | 5 points for complete export and quality-document packages; 2–4 points for standard commercial documentation. |
| 10 | Environmental and Resource Management | 5% | Use of recycled glass where technically suitable, furnace-energy management, waste reduction, emissions controls, and environmental-management practices. | 5 points for verified environmental systems and measurable improvement data; 2–4 points for documented basic initiatives. |
