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Quality & Regulatory Compliance System To Mitigate Risks

Quality & Regulatory Compliance System To Mitigate Risks

Redundant Manufacturing Facilities

  • Certified ISO Class 7 assembly rooms
  • Validated equipment and processes

ISO 9001 Quality System

  • Compliant with GMP/EMA requirements
  • Robust and timely complaint and CAPA programmes
  • Risk-based quality management approach

Complete Regulatory Compliance Programme

  • Animal origin-free or EMA 410-compliant
  • Sterile barrier validation per ANSI/AAMI/ISO 11607
  • ISO 11137 sterility validation
  • Endotoxin USP <85> & Particulate USP <788> on lot release available
  • BPOG standardise extractables testing protocol-capable and in use