main steps of process validation in the pharmaceutical industry:
Stage Objective Key Activities
- Define Critical Quality Attributes (CQAs) for the product.
Design a process that ensures consistent product
1. Process Design - Identify Critical Process Parameters (CPPs) affecting CQAs.
quality.
- Develop control strategies to mitigate risks.
Confirm that the designed process works effectively
2. Process Qualification Sub-stages include:
at scale and under real-world conditions.
Ensure that equipment and facilities meet required - Verify that facilities, systems, and equipment meet the design
- Design Qualification (DQ)
specifications. requirements.
- Installation Qualification - Test equipment installation.
Verify that equipment is installed correctly.
(IQ) - Check calibration and utilities.
- Operational Qualification Ensure equipment operates correctly under
- Run equipment tests under normal and stress conditions.
(OQ) specified conditions.
- Performance Qualification Confirm the process consistently produces - Run the process multiple times using production-scale equipment.
(PQ) acceptable results. - Confirm consistent performance and output quality.
- Implement ongoing monitoring of process performance and product
quality.
3. Continued Process Continuously ensure that the process remains in
- Use statistical process control (SPC) and other monitoring tools.
Verification control and produces consistent quality products.
- Investigate and resolve deviations.
- Periodically review process data and revalidate as necessary.
- Conduct risk management throughout the lifecycle.
Ensure all stages of validation are compliant and
Supporting Activities - Ensure regulatory compliance with FDA, EU, and other guidelines.
effective.
- Ensure complete documentation at all stages.
