Environmental Monitoring (EM) programs for pharmaceutical manufacturing are consistently moving toward a risk-based approach, using proactive data analysis to control environmental factors in a manufacturing environment. Identifying and mitigating risks up front with sampling data is proving to be much more effective than more reactive methods. However, questions remain about how to shift from a standard EM approach to one that predicts risk early and sets a framework for avoiding it. We will teach you how during this session.
Areas Covered in the Session :
Applying a Risk Management approach to developing an Effective Environmental Monitoring program
- First lesson learned – describe the different approaches to establishing initial EM sites (Performance Qualification) to ensure sufficient baseline data exist to support cleaning program effectiveness
- The RPN approach is great
- Incorporate Risk Mitigation steps to show how the Risks are mitigated
- Sort the scores to identify what locations are most important
- Geometrical coverage
- Cover all areas of the room using equation to determine sampling sites based on room square footage
Implementing a Risk Based E/M Program (making it work in the Real World)
- Telling the story of how you decided on your E/M monitoring locations becomes part of the Process Development part of Process Validation per the 2011 PV Guidance
- Trend reports are necessary to determine the effectiveness of the system
- Revise your E/M locations based on your E/M data. – this will give you credibility with the Agency
Case Study – Dealing with Environmental Control Issues in Cleanrooms
- You will be dealing with panicky Management
- Handling the Deviation / Investigation
- Using Risk Assessment approaches to identify Corrective Actions
Who Should Attend:
- Quality Assurance Departments
- Quality Control Departments
- Research and Development Departments
- Manufacturing Departments
- Engineering Departments
- Operations Departments
- Production Departments
- Validation Departments
- Microbiologists
- Everyone concerned with environmental monitoring for contamination control and sterility