It is a Regulatory Requirement to have in place a Contamination Control Strategy (CCS) in Life Sciences Industries. CCS should be implemented across the facility to define all critical control points and assess the effectiveness of all the controls and monitoring measures employed to manage risks associated with contamination.
Processes, equipment, facilities, and manufacturing activities should be managed in accordance with QRM principles to provide a proactive means of identifying, scientifically evaluating, and controlling potential risks to quality.
Personnel should have adequate qualifications and experience, training, and behavior with a specific focus on the principles involved in the protection of sterile products during the manufacturing, packaging, and distribution processes.
Raw materials and packaging materials should be adequately controlled and tested to ensure that level of bioburden and endotoxin/pyrogen are suitable for use.
How Mivado GlobalPerformance can help you implement your Contamination Control Strategy? We provide necessary resources and tools together with your staff to document site-wide strategy for minimizing contamination throughout the life cycle of your existing or new facility. Note that CCS is a living document that needs to be periodically reviewed. Our Contamination Control Service includes:
Facility & Maintenance
- Facility, Utilities, System Equipment Risk Management and Control
- Preventive Maintenance Evaluation
- Vendor Approval
Manufacturing Process
- Product containers and closures Process Risk Management and Control
- Process Validation
- Cleaning and disinfection Program
Quality System
- Personnel
- Monitoring systems
- Prevention- trending, investigations, CAPA
- Continuous improvement
Prevention
- Process Design
- Facility Design
- Qualification & Validation
- Testing & Release
- Employee Training
Remediation
- Cleaning & Disinfection
- Decontamination
- Sterilization
- Investigation & CAPA
Monitoring
- Data Trending
- Early Warning
- Feedback
- Employee Training
Implementing and maintaining the CCS will help you achieve a state of control that is required to ensure product quality and patient safety. The CCS needs to be maintained regularly and made part of the periodic product quality review to ensure that any changes in the input materials, facility design, or production process have been implemented in accordance with QRM and QMS.
