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