New Facilities and Installations
Define requirements and create documented evidence before GxP use.
GxP FACILITIES, UTILITIES AND EQUIPMENT
Commissioning and Qualification for GxP Facilities, Utilities and Equipment
Labmerit provides risk-based commissioning and qualification support for new and existing GxP facilities, utilities, production equipment and laboratory equipment. We connect engineering execution with quality oversight - from requirements and design review through commissioning, DQ, IQ, OQ, PQ, final reporting and requalification.
Risk-based lifecycle approach
Onsite execution
Traceable documentation
Integrated technical support
WHEN C&Q IS NEEDED
From New Installations to Lifecycle Requalification
A structured commissioning and qualification approach is typically needed when a new facility, utility, system or item of equipment is introduced, and when an existing installation is upgraded, relocated or significantly changed. It is also used to support periodic requalification, remediation of legacy systems and preparation for regulatory inspection.
Upgrades and Reconstruction
Assess the impact of changes and verify the modified system.
Equipment Transfer or Relocation
Confirm installation, operation and continued suitability at the new location.
Significant Changes and Remediation
Address compliance gaps, deviations or changes that may affect intended use.
Periodic Requalification
Demonstrate that the system remains suitable and under control throughout its lifecycle.
SCOPE OF SERVICES
Scope of Services
Planning and System Definition
- User Requirements Specification development and review support
- definition of intended use and system boundaries
- GxP impact and criticality assessment
- commissioning and qualification strategy and planning
- risk assessment and definition of verification priorities
- definition of responsibilities, acceptance criteria and required documentation
Design and Commissioning
- design review and Design Qualification
- review of engineering, technical and vendor documentation
- commissioning planning and test support
- review and use of relevant FAT, SAT and vendor test evidence, where justified by the approved qualification strategy
- coordination between the client, designers, suppliers, contractors, engineering teams and Quality Assurance
Qualification and Lifecycle Support
- Installation Qualification protocol preparation, execution and reporting
- Operational Qualification protocol preparation, execution and reporting
- Performance Qualification protocol preparation, execution support and reporting
- requalification following defined intervals, significant changes or system relocation
- traceability matrix preparation
- deviation assessment and support in defining corrective actions
- final qualification reporting
- change-impact and requalification assessment
SYSTEMS AND EQUIPMENT
Facilities, Utilities and Equipment Covered
Facilities and Controlled Environments
Pharmaceutical production and laboratory facilities; cleanrooms and controlled environments; HVAC systems; warehouses and temperature-controlled areas.
Critical and Process Utilities
Purified water and water for injection systems; clean and pure steam systems; compressed air; nitrogen, argon and other process gas systems; vacuum systems.
Production and Laboratory Equipment
Manufacturing and process equipment; laboratory equipment; packaging lines; cold rooms, refrigerators, freezers, climatic chambers and other temperature-controlled units.
Thermal Equipment
Autoclaves; dry-heat sterilizers; depyrogenation equipment; thermostatic and thermal-processing equipment.
OUR C&Q LIFECYCLE APPROACH
Our C&Q Lifecycle Approach
Define
Establish the intended use, user requirements, system boundaries, project responsibilities and expected outputs.
Assess
Evaluate GxP impact, criticality and risk and define acceptance criteria and verification priorities.
Design & Commission
Review the design and supplier documentation and coordinate commissioning, FAT and SAT evidence as applicable.
Qualify
Prepare and execute controlled IQ, OQ and PQ testing using suitable calibrated measuring equipment.
Report
Document results, deviations, traceability and final qualification conclusions.
Maintain
Support change-impact assessment, periodic requalification and continued lifecycle control.
KEY DELIVERABLES
Key Deliverables
Depending on the agreed project scope, deliverables may include:
Responsibility boundary
Final approval of requirements and acceptance criteria, as well as release of the facility, utility, system or equipment for GxP use, remains the responsibility of the client.
- commissioning and qualification plan
- URS development or review support
- GxP impact and risk assessment
- Design Qualification report
- commissioning and test documentation
- IQ, OQ, PQ and requalification protocols and reports
- traceability matrix
- deviation assessments and corrective-action recommendations
- final qualification report
- recommendations for change control, periodic review and requalification
CLEAR SERVICE BOUNDARIES
Clear Service Boundaries
Commissioning and Qualification
Demonstrates that facilities, utilities and equipment are designed, installed and operating in accordance with their intended use.
Process Validation
Demonstrates that a manufacturing or thermal process operating within defined parameters can consistently deliver results that meet predefined quality requirements.
Explore Process ValidationComputerized Systems Validation
Addresses software functionality, electronic records, data integrity, user access, audit trails, interfaces and other GxP computerized-system requirements.
Explore CSVThermal-equipment rule. Qualification of autoclaves, dry-heat sterilizers and depyrogenation equipment belongs to Commissioning and Qualification. Development and validation of the sterilization or thermal cycle belongs to Process Validation. Computerized controls and data-integrity functions are linked to Computerized Systems Validation.
INTEGRATED TECHNICAL SUPPORT
Integrated Testing, Calibration and Accreditation Status
Where a qualification project requires technical testing or calibration, Labmerit can coordinate these activities within one project approach. This enables consistent planning, field execution, traceability and reporting while keeping the regulatory status of each activity clear.
Commissioning and Qualification are professional GxP services outside Labmerit's accredited scopes. Where a project includes specific testing within Testing Laboratory Scope 01-303 or calibration within Calibration Laboratory Scope 02-071, only those specific activities and results are identified and reported as accredited in accordance with the applicable scope.
View Accreditation and Current Scopes →REGULATORY AND INDUSTRY FRAMEWORK
Regulatory and Industry Framework
Projects are planned according to applicable client and regulatory requirements, including EU GMP Annex 15 and risk-based commissioning and qualification principles. Depending on the system, intended use and target market, relevant FDA, WHO, GDP, Good Engineering Practice, ISPE and ASTM E2500 principles and guidance may also be applied.
WHY LABMERIT
Why Labmerit
Labmerit combines engineering, GxP validation and qualification expertise with the technical competence of ISO/IEC 17025-accredited testing and calibration laboratories.
one coordinated team from planning through onsite execution and final reporting
multidisciplinary engineering, validation, measurement and quality expertise
integration of qualification with applicable testing and calibration activities
traceable, audit-ready lifecycle documentation
experience supporting complex GxP projects across Europe and in the Kingdom of Saudi Arabia (KSA)
long-term support for requalification, changes and system lifecycle maintenance
Planning a New Installation, Upgrade or Requalification?
Tell us about your facility, utility, equipment or upcoming change. Our team will help define an appropriate qualification scope, project approach and required documentation.
Discuss Your Project