Electronic Data in Pharmaceutical Manufacturing: Rapid Response to Deviation Events (Series Part 4 of 6)
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.