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
