Process Validation

7.4 Process Validation

• 7.4.1 Process Design

  • 7,4.1.1 Development: Designing manufacturing processes that ensure product quality and consistency.

  • 7.4.1.2 Risk Assessment: Identifying and mitigating risks in manufacturing processes.

• 7.4.2 Process Qualification

  • 7.4.2.1 Installation Qualification (IQ): Ensuring equipment is installed correctly and to specifications.

  • 7.4.2.2 Operational Qualification (OQ): Testing equipment and systems to ensure they operate as intended.

  • 7.4.2.3 Performance Qualification (PQ): Confirming that the process produces the desired product under real-world conditions.

• 7.4.3 Continued Process Verification

  • 7.4.3.1 Monitoring: Ongoing monitoring of processes to ensure consistent product quality.

  • 7.4.3.2 Data Analysis: Reviewing and analyzing data to detect any deviations or trends.