Rapid Response to Deviation Events
The creation of risk assessment documentation is a basic requirement for implementing a monitoring plan, and rapid response to deviation events is expected. ISO 14644 requires manufacturers to create and use a risk assessment document as a tool to correctly understand the Risk Assessment and Action/Alert setting processes. The determination of action and alert limits, as well as the definition of sampling point location, is extremely important. This must be supported by the Risk Assessment as well as historical sampling data and monitoring controls.
Response to and CAPA (Corrective Action Preventative Action) activities around deviation events must be swift. However, this quick action requires an understanding of the baseline operations of the environment and knowledge of what led up to the event. In the past, much of this fell to the experience and wisdom of available cleanroom owners and operators. Today, automated data collection, analysis and trending removes human bias and makes this decision making more precise and effective, and much less time consuming.
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to Cleanroom Monitoring & Data Integrity: PharmaIntegrity
See links to additional supporting resources below:
Application Note: Particle Data Collection and Interpretation for ISO Cleanrooms
Application Note: Understanding ISO Standards: ISO 14644-2:2015 Cleanroom Monitoring
On-Demand Webinar: USP 1116 and its Implications for Measuring Microbial Recovery Rates
Application Note: Webinar FAQ – USP 1116 and its Implications for Measuring Microbial Recovery Rates
Want to read more? Jump to other released posts in this series:
Part 1 of 6: Data Integrity
Part 2 of 6: Paperless Reporting
Part 3 of 6: Secure Data Transfer
Part 5 of 6: Reducing Operator Error
Part 6 of 6: Real-Time Microbial Monitoring
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