Quality Systems

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In addition to our outstanding credentials, Aphena has many systems in place to ensure quality during the production of every product.


  • Full Validation Program
    • Master Validation Plan
    • Equipment IQ, OQ, PQ
    • Process
    • Cleaning
    • Facilities / Environment
    • Laboratory
  • Enterprise Quality Management Software System
  • Laboratory Information Management System
  • Workflow Control: Receiving, Production & Shipping
  • Master Batch Services Record Development & Documentation
  • Rigorous Management of Change Control
  • CAPA Program (Corrective And Preventive Action)
  • Detailed Standard Operating Procedures Training Program
  • Robust In-Process Testing & Verification Systems