Equipment Qualification
Equipment Qualification comprises a series of qualifications defining designs, installation, operational, and performance qualification assuring consistent and anticipated equipment functionality. Operating parameters and environment, documented routine maintenance, and continuous performance checks contribute to a life-cycle approach to maintaining equipment in a validated state. MEDVACON's experienced team of equipment qualification experts can assist you with:
- Equipment Installation Qualification (IQ):
- Documentation review and verification of equipment installation
- Ensuring equipment is properly installed per manufacturer’s specifications
- Equipment Operational Qualification (OQ):
- Performance testing to ensure equipment operates within specified parameters
- Verification of equipment functions and controls
- Equipment Performance Qualification (PQ):
- Testing equipment under actual production conditions
- Verification of consistent and reliable equipment performance
- Equipment Calibration and Validation:
- Verification of calibration services to ensure accuracy of measuring and monitoring equipment
- Validation of critical measurement equipment used in manufacturing and testing
MEDVACON’s experienced team of equipment qualification experts can assist In the following areas:
- Process Equipment Qualification:
- Qualification of equipment used in manufacturing processes
- Ensuring equipment contributes to the desired process outcomes
- Packaging Equipment Qualification:
- Qualification of packaging machinery and systems
- Verification of proper packaging process and integrity
- Laboratory Instrument Qualification:
- Qualification of analytical instruments and lab equipment
- Ensuring accuracy and reliability of testing and analysis
- Warehouse Equipment Qualification:
- Qualification of storage and handling equipment
- Verification of proper storage conditions and material handling
- Medical Device Equipment Validation:
- Validation of equipment used in medical device manufacturing
- Ensuring compliance with medical device regulations and standards
- Computer System Validation (CSV):
- Validation of computerized systems and software used in equipment control
- Ensuring data integrity and system reliability
- Risk Assessment and Mitigation:
- Identification of equipment-related risks and potential hazards
- Implementation of risk control measures and strategies
- Cleaning Validation of Equipment:
- Validation of equipment cleaning procedures
- Ensuring removal of contaminants and residues
- Equipment Change Control:
- Validation of equipment changes and modifications
- Ensuring that changes do not adversely affect product quality
- Documentation and Record Management:
- Creation and maintenance of equipment qualification documentation
- Ensuring accurate and accessible records for regulatory compliance
- Training and Education:
- Training programs for personnel involved in equipment qualification
- Ensuring proper understanding of qualification processes and requirements
- Operational Readiness Assessment:
- Evaluation of equipment readiness for production
- Verification that equipment is prepared for operational use
- Vendor Audit and Supplier Qualification:
- Assessment of equipment suppliers and manufacturers
- Verification of supplier compliance with quality standards
- Performance Monitoring and Maintenance:
- Monitoring equipment performance over time
- Implementation of preventive maintenance strategies
- Validation Consultation and Advisory Services:
- Expert guidance and consultation on equipment validation strategies
- Ensuring compliance with industry regulations and best practices
MEDVACON’s Qualification specialists help clients ensure their equipment performs as intended. By applying a risk-based methodology, our experienced 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
Packaging Equipment / Line Qualification
MEDVACON designed and implemented a matrix approach to qualifying all of our pharmaceutical client's OSD packaging lines. To ensure compliant validation and cost and time efficiency, MEDVACON's team of experts evaluated the client's product specifications and packaging line specifications and capabilities that required a matrixed approach. MEDVACON further evaluated the existing equipment qualification protocols to identify deficiencies, outline new intended uses, and conduct performance qualifications of the integrated packaging lines. This approach allows the client to onboard new products to the packaging lines with a systematic, compliant, efficient and defendable validation approach.
Medical Device Component Manufacturing
In partnership with a medical device component manufacturer, MEDVACON evaluated the impact of a planned manufacturing facility relocation on equipment qualification. MEDVACON identified components from the point of order generation to the completion of manufacturing to the movement of the component to shipping. The manufacturing process was assessed for reproducibility and operational efficiency and a report was developed for the manufacturer to satisfy their medical device customer's quality units.
Manufacturing Equipment Qualification
MEDVACON assisted a pharmaceutical client manufacturing oral solid dose (OSD) tablets to qualify production equipment. MEDVACON developed and executed Installation and Operational Qualification (IQ/OQ) protocols for Mixers, Blenders, Fluid Bed Drier's and Tablet Presses.
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