A very important question to formulate is: What to monitor in a GMP Environment?, and the answer is, all parameters known or susoected to impact the quality efficacy, purity or safety of the product. These are some examples of these parameters:

• Critical Process Parameters (CPP)
• Product Critical Quality Attributes (CQA)
• Process Performance Indicators
• Process Deviations
• API atributes such as purity
• Performance Indicators for Critical Support Services (Water, HVAC)
• Environmetal Conditions surrounding the process (Environmental Monitoring)
• Personnel Performance Indicators
• Supplier Performance Indicators
• Laboratory Analytical Results
• Analytical Results Out of Specifications (OOS)

In short, monitoring should cover the entire operation and shoud collect appropriate data and be implemented at the appropriate frequency.

Another important question is: Where to Monitor?. Monitoring is always performed at the critical points within the operation, which are normally defined at the Development step and confirmed during Transfer step. In Manufacturing Procesess for example, points where problems are known to occur or likely to occur and at the end of any critical step. When monitoring water systems, data should be collected at critical steps in the process and at the points of use. In air monitoring, there should be monitored viable and non-viable particles, surfaces where human or machine activities occur, and the doors, where the direction of airflow is of critical imporane to prevent cross contamination.