Design and Manufacturing Information

Required content

• Manufacturing sites — names, addresses, scope of activities
• Manufacturing process — key steps, critical control points
• Critical components and raw materials — specifications
• Sterilisation — method and validation summary (for sterile devices)
• Environmental controls — cleanroom classification where relevant
• Incoming QC — for critical components

KGMP alignment

Manufacturing information in the STED must be consistent with the KGMP certificate scope. Discrepancies identified during MFDS review will trigger clarification requests.