Process Validation
Process validation is defined as the collection and evaluation of data, from the process design stage through commercial production, which establishes scientific evidence that a process is capable of consistently delivering quality product. Process validation involves a series of activities taking place over the lifecycle of the product and process.
Stages of Process Validation
Stage 1 – Process Design
The commercial manufacturing process is defined during this stage based on knowledge gained through development and scale-up activities.
- Building Process Knowledge: Conducting experiments (often at lab or pilot scale) to understand the process, even if not under cGMP conditions.
- Using Risk Analysis and DoE: To identify critical process parameters and optimize them.
- Establishing Process Control Strategies: Based on understanding variability and ensuring consistent product quality through well-documented control approaches.
Stage 2 – Process Qualification
During this stage, the process design is evaluated to determine if the process is capable of reproducible commercial manufacturing.
- Design of Facility and Equipment Qualification: Ensure facilities, equipment, and utilities are appropriately designed and qualified.
- Confirm systems operate correctly under expected commercial production conditions.
- Process Performance Qualification (PPQ):Combine qualified equipment, facilities, and trained personnel to produce commercial batches.Confirm that the process consistently performs as expected under real manufacturing conditions.
Stage 3 – Continued Process Verification
Ongoing assurance is gained during routine production that the process remains in a state of control.
- Ongoing Monitoring: Continuously collect and analyze data on process performance and product quality.
- Detection of Variability: Identify and address unplanned deviations or variations in the process.
- Statistical Analysis: Use statistical methods to monitor process stability and capability, adjusting monitoring levels as needed.
Read also:
- Validation and Qualification In Pharmaceutical Manufacturing
- Pharmaceutical Validation Interview Questions and Answers
Resource Person: Deepak Chandra Sharma