Change and Risk Management in Continuous Process Validation
To be able to implement the three-stage approach to CPV, the conditions must first be created in the development organization of the company.
Quality by Design is the tool to be able to approach the process design, to further develop the process in a controlled and documented manner and to define the CQAs (Critical Quality Attributes) as well as the CPP (Critical Process Parameters) using PFMEA (Process Failure Mode and Effects Analysis) based on the process knowledge already acquired. The PPQ (Process Performance Qualification), comparable to the traditional process validation, is implemented at the end of the second stage and is meant to substantiate the process suitability and process reproducibility.
Continuous Process Validation, the third stage, means the continuous monitoring of the process and (statistical) evaluation of the generated data, including the data received from stability studies and studies that result from non-conformities and complaints.
The biggest advantage of the three-stage approach is the already statistically evaluable data volume for the implementation of the PPQ.
This results in a considerably clearer and more accurate image of the processes, which in turn meets the requirement of the authorities.
In our expert presentation at the symposium “Continuous Process Validation” of ChemAcademy on 29 February 2016, we will deal with this third stage in detail. In addition, we will shed light on the advantages of the improved approach compared to the traditional approach and also discuss the importance of change control management and risk management according to ICH Q9.