1. Risk-based approach
This approach involves identifying and assessing potential risks associated with the manufacturing process and implementing controls to mitigate those risks. It is recommended by both EMA and FDA as a key element of process validation.
2. Continuous process verification (CPV)
This approach involves ongoing monitoring of critical process parameters and product quality attributes to ensure that the manufacturing process remains in a state of control. CPV is recommended by both EMA and FDA as a means of ensuring ongoing product quality.
3. Quality by Design (QbD)
This approach involves designing quality into the manufacturing process from the outset, rather than relying on post-production testing to ensure product quality. QbD is recommended by both EMA and FDA as a means of improving product quality and reducing the risk of manufacturing failures.
4. Process analytical technology (PAT)
This approach involves using real-time monitoring and control of critical process parameters to ensure that the manufacturing process remains in a state of control. PAT is recommended by both EMA and FDA as a means of improving product quality, reducing variability, and increasing efficiency.
5. Statistical Process Control (SPC)
This approach involves using statistical methods to monitor and control critical process parameters, with the aim of ensuring that the manufacturing process remains in a state of control. SPC is recommended by both EMA and FDA as a means of improving product quality, reducing variability, and increasing efficiency.
6. Retrospective validation
This approach involves validating an existing manufacturing process based on historical data, rather than conducting validation studies from scratch. Retrospective validation is recommended by both EMA and FDA as a means of reducing costs and minimizing disruption to ongoing production processes.
Read details: Process Validation in Pharmaceutical Industry
Resource Person: Ershad Moradi
