Potential Impact Levels of the Category “Complexity”
| Risk Level | Factor | Impact Assessment | Examples |
|---|---|---|---|
| 4 | 8 | Product directly used by patient or Manufactured via highly complex processes | Patient use: Requires specific training/assessment, e.g., self-injection or Manufacturing/trading: sterile products, aseptic production, sterile API or Sterile packaging material or Products required to be manufactured under strict separation regimes |
| 3 | 4 | Product directly used by the patient and manufactured via a complex process or Manufactured in complex processes or requiring complex services to maintain quality | Patient use: No specific training required, e.g., oral administration or Manufacturing/trading: nonsterile finished products, Bulk nonsterile drug product or Storage & distribution: “Key Warehouse”; products with special storage/transport requirements |
| 2 | 2 | Compounds not directly used by patients or Services with no direct impact on patient health/safety | Manufacturing/trading: nonsterile API/API-Biotech products/specified excipients or Packaging material: any other or Operations limited to packaging only or Storage & distribution: warehousing only |
| 1 | 1 | Compounds only used during manufacturing processes | Manufacturing/trading: Starting materials/raw materials/excipients |