A reliable and flexible approach to CQV
Normec supports organisations with the qualification and validation of facilities, equipment, utilities and manufacturing processes. We ensure that systems perform reliably and efficiently from initial testing through to commercial production.
Whether you are commissioning new facilities, expanding existing operations or optimising production processes, we help you maintain control over quality and regulatory compliance.
Expertise in equipment, utilities and validation
Successful CQV projects require technical expertise, practical experience and a thorough understanding of GMP and GxP requirements. Our specialists have extensive experience in complex manufacturing environments and understand the challenges of pharmaceutical production.
Our expertise includes:
- Qualification of facilities, equipment and utilities
- Cleaning and sterilisation validation
- Formulation equipment, including mixing systems and filtration systems
- CIP (Clean-in-Place) and SIP (Sterilise-in-Place) systems
- Sterile isolators and Restricted Access Barrier Systems (RABS)
- Preparation equipment, including autoclaves and parts washers
- Sterile filling lines and inspection machines
We ensure that your systems comply with applicable regulations while continuing to operate reliably in day-to-day production.
Flexible support at every stage
Some organisations require end-to-end project support, while others need additional expertise during specific phases of commissioning, qualification or validation. That is why we tailor our services to your project requirements.
Our support includes:
- Guidance during Factory Acceptance Tests (FAT)
- Support during Site Acceptance Tests (SAT)
- Preparation of User Requirements Specifications (URS)
- Execution of qualification and validation protocols
- Practical support during commercial start-up
- Training and on-site testing
Quality, compliance and operational reliability
A well-executed CQV programme helps organisations reduce risk and establish stable, reliable manufacturing processes. Potential issues are identified earlier, deviations are easier to manage and organisations are better prepared for inspections and audits.
With our support, you can:
- Achieve a more reliable start-up of manufacturing processes
- Strengthen compliance with GMP and GxP requirements
- Reduce deviations and unplanned downtime
- Qualify equipment and utilities more efficiently
- Improve readiness for inspections and audits
Together, we help build manufacturing environments that are ready for the future of pharmaceutical and biotechnology production.
Would you like to know more about CQV?
Frequently Asked Questions
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CQV stands for Commissioning, Qualification and Validation. It covers the testing, qualification and validation of systems, equipment and manufacturing processes within the pharmaceutical and life sciences industries.
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CQV helps organisations ensure the quality, safety and regulatory compliance of production processes, facilities and equipment.
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Commissioning focuses on ensuring that systems are installed and operate as intended. Qualification then demonstrates that those systems consistently perform according to predefined specifications.
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Cleaning and sterilisation validation verifies that cleaning and sterilisation processes are effective, reproducible and compliant with regulatory requirements.
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Yes. We provide support during both Factory Acceptance Tests (FAT) and Site Acceptance Tests (SAT).
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A User Requirements Specification (URS) defines the functional and technical requirements that a system or installation must meet.
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We support pharmaceutical companies, biotechnology organisations and other businesses operating within the life sciences and healthcare sectors.