Facilities and Utilities Commissioning & Qualification
Facilities and utilities commissioning and qualification are essential processes within regulated industries, such as pharmaceuticals, biotechnology, medical devices, and food manufacturing. These processes involve a series of systematic activities that ensure the proper design, installation, operation, and performance of critical infrastructure, equipment, and systems used in the production and distribution of products. The primary goal of commissioning and qualification is to establish documented evidence that these facilities and utilities consistently meet predetermined specifications and regulatory requirements. MEDVACON's experienced team of experts can assist you with:
- Facility Commissioning and Qualification:
- Comprehensive facility assessment and evaluation
- Design and implementation of commissioning plans
- Installation qualification (IQ) for equipment and systems
- Operational qualification (OQ) of facility components
- Performance qualification (PQ) for facility systems
- Utility Systems Validation:
- Steam and condensate system validation
- Water purification and distribution system validation
- HVAC (Heating, Ventilation, and Air Conditioning) system validation
- Compressed air system validation
- Electrical distribution system validation
- Equipment Qualification:
- Equipment installation qualification (IQ)
- Operational qualification (OQ) of individual equipment
- Performance qualification (PQ) of equipment
- Calibration and maintenance validation
- Environmental Monitoring System Validation:
- Validation of cleanroom and controlled environment monitoring systems
- Data integrity and data acquisition validation
- Alarm and notification system validation
- Validation Documentation Services:
- Development of validation master plans (VMPs)
- Preparation of validation protocols and test scripts
- Compilation of validation summary reports
- Validation deviation and CAPA management
- Risk Assessment and Mitigation:
- Risk assessment for facilities and utilities systems
- Risk-based approach to commissioning and qualification
- Implementation of risk control measures
- Regulatory Compliance Support:
- Alignment with industry regulations (e.g., FDA, EMA, ICH)
- Support during regulatory inspections
- Documenting compliance with regulatory requirements
- Project Management for Commissioning and Qualification:
- Coordination of validation activities and timelines
- Project planning and resource allocation
- Progress tracking and reporting
- Process Validation Integration:
- Integration of facilities and utilities validation with process validation
- Ensuring the overall product quality and safety
- Training and Workshops:
- Training programs on commissioning and qualification best practices
- Workshops on regulatory requirements and industry guidelines
- Operational Readiness Assessment:
- Evaluation of facility and utility readiness for production
- Validation of startup and shutdown procedures
MEDVACON’s Facilities and Utilities Commissioning specialists help clients ensure their facility, utilities, and equipment perform as intended. By applying a risk-based methodology, our experienced commissioning and qualification team maximizes time and cost efficiencies through focused qualification. MEDVACON’S ability to apply industry trends and analyses to help define and implement best practices ensures rapid adaption to client project requirements.
Example Projects:
HVAC, Air Compressors & Dust Collection Qualification
MEDVACON provided a multitude of facility activities for the qualification of 16 air handling HVAC units, two facility-duty air compressors, and two dust collection units all serving the GMP packaging and lab areas. MEDVACON's team of utility qualification engineers developed and executed Installation and Operation Qualification (IQ/OQ) protocols for all the equipment and developed all of the qualification reports.
Flammable Mixing Vessel Containment
For a pharmaceutical company manufacturing various types of products, MEDVACON evaluated the design for their flammable mixing vessel, explosion proof Room, and transmission of the product to the filling line for packaging. MEDVACON conducted a regulatory and design analysis of the process, room, equipment, and transmission lines that the client used for regulatory compliance.
Biopharmaceutical Facility Water System
MEDVACON was engaged by a Biopharmaceutical startup to manage the facility and equipment qualification project. The MEDVACON senior PM and Technical consultant was also tasked with validating the client’s unique approach to manufacturing water. The MEDVACON PM and MEDVACON resources worked with the client, their suppliers, and internal resources to qualify this unique approach to sourcing water for the manufacturing process. With the help of MEDVACON the client successfully started up the facility with cGMP compliance and is making commercial batches today.
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