Commissioning & Qualification

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The structure and resources to move your project to completion.

Commissioning & Qualification

Hyde has been supporting commissioning + start-up production facilities, process equipment and control systems for decades. Our approach to qualification incorporates our in-depth understanding of global regulatory guidelines (USFDA, EMA, MHRA, Health Canada, WHO). We provide onsite / offsite C&Q services for BioPharma, Vaccines, Oral Solid Dosage, Fill / Finish, Parenteral, Medical Device and Nutraceutical facilities.

Services Include
  • Cleaning Validation
  • Circuit OQ and PQ Development, Execution, and Final Reports
  • Commissioning Documentation and Support
  • C&Q Project Management / Owners Representation
  • Development of Traceability Matrices, GAP Analysis
  • Document Management
  • DQ, IQ, OQ and PQ Protocol Development and Execution and Reports
  • Equipment and Qualification
  • Factory Acceptance Testing / Site Acceptance
  • Master Planning (Commissioning, Qualification + valid
  • Process Validation
  • Risk-based approaches (ASTM E2500, ICH-Q9 principles)
  • Steaming Validation
  • System Start-up + execution
Systems
  • Automation
  • Black Utilities
  • Clean Utilities
  • Facility / HVAC
  • Process