Life Sciences
Commissioning, Qualification and Validation (CQV)
Prompt, knowledgeable CQV support for bio-pharma GMP manufacturing.
The Advent Engineering team, part of Trinity Consultants, provides expert CQV support for bio-pharma GMP manufacturing.
Our team of Commissioning, Qualification, and Validation (CQV) experts support our client’s GMP’s manufacturing facilities to lead and execute CQV activities against their facility, utilities, equipment, automation system, enterprise/IT systems, and analytical equipment. We have extensive experience in the practical application of risk-based (ASTM E-2500) verification methods and subject matter expertise in all aspects and phases of the CQV lifecycle.
Deep Expertise, Broad Spectrum of Services
In this video, Albert Dyrness, Managing Director, Trinity Life Sciences, discusses the Trinity Life Sciences difference.
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Commissioning, Qualification and Validation
Phases of the CQV Lifecycle
Our deep industry expertise shines in all aspects and phases of the CQV lifecycle including:
- Validation master planning, protocols and test scripts / test forms
- Risk assessments including FMEA, PHA providing lifecycle control strategies
- Design verification to support design review, factory acceptance & site acceptance
- Process and cleaning validation with a QbD approach
- Cycle development and performance qualification (for CPP, CQA establishment)
- Analytical instrument qualification and method validation
- Requalification and revalidation including periodic review
- Technical registration document management
- Data integrity assessments
- Custom software (cloud-based) for change & deviation management for capital and site projects
Sample CQV Projects
Our highly qualified CQV team supports a wide range of systems including process equipment, facilities and utilities, automated systems, quality control labs and analytical instruments, medical devices, combination products, and enterprise/IT systems. Sample CQV projects include:
- Turn key CQV for new and expanded facilities for GMP processing
- Risk-based or integrated CQV using guidelines (ICH, ASTM-E2500, PDA, ISPE)
- CIP cycle development and cleaning verification
- SIP cycle development and TC/BI placement for PQ
- Isolator VHP cycle development and decontamination cycle verification
- Recovery studies for cleaning verification
- Proactive troubleshooting and resolution of verification exceptions
- Thermal mapping, autoclave sterilization development