Process Validation

MANUFACTURING PROCESS VALIDATION

IQ – OQ – PQ protocols for

  • Ampoules manufacturing process.
  • Vials manufacturing process.
  • 100% IPC text print (camera validation).
  • 100% IPC cosmetic defects (camera validation).
  • Autoclave.
  • 100 % IPC dimensional controls.
  • Advanced 100% controls system for:
    • Colour ID band check.
    • Glass Integrity (breakages, cracks).
    • Internal siliconization conformity.
    • No-contact glass thickness/concavity control devices.
    • Breaking force control devices.

DMF 14744 TYPE III FDA USA

DMF-2005-010 HEALTH CANADA

DMF CHINA ONGOING

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