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It is Regulatory Requirements to have in place Contamination Control Strategy (CCS) in Life Sciences Industries. CCS should be implemented across the facility in order to define all critical control points and assess the effectiveness of all the controls and monitoring measures employed to manage risks associated with contamination. 

CONTAMINATION CONTROL STRATEGY

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 behaviour with a specific focus on the principles involved in the protection of sterile product 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 implementing 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 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 maintening the CCS will help you achieving a state of control that is required to ensure product quality amd 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 the production process have been implemented in accordance with QRM and QMS.

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