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.

• 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

• Automation
• Black Utilities
• Clean Utilities
• Facility / HVAC
• Process