Monitoring Controls

Systems overseeing processes

Monitoring controls are controls put in place to evaluate process performance. Monitoring controls should include in-line, on-line, and at-line monitoring to ensure all aspects of the process are operating as expected. Examples of monitoring controls include parameters tested, number & size of samples, and frequency of monitoring. Most often, these aspects of monitoring are utilized in the continous process verification stage of the cleaning validation program in order to maintain a state of control of the process and to make process improvements.