Process Validation and Verification Explained
Process validation and verification is one of the most common activities for process engineers in the manufacturing field. In this article, I will explain the key concepts of process validation and process verification. While these terms are often used interchangeably in the real world, they serve distinct purposes. Therefore, it is crucial to understand when and how each activity is used correctly.
Understanding Process Validation and Verification
What is Process Validation?
Process validation is the systematic approach of establishing documented evidence that a process consistently produces a product meeting its specifications and quality attributes. It is crucial for guaranteeing product quality, safety, and efficacy.
What is Process Verification?
Process verification involves the ongoing activities that confirm the established processes continue to operate in a state of control. It ensures that the validated processes remain effective and aligned with the predefined quality standards.
Overview of Process Validation
Purpose:
- To establish, through documented evidence, that a process consistently produces a product meeting predetermined specifications and quality attributes.
- It focuses on the entire process, from start to finish, consistently meets quality standards.
Timing:
- Typically conducted during the development or introduction of a new process, manufacturing site, or equipment before the process is fully implemented for routine production.
Activities involved:
- Designing a validation plan, executing validation protocols, analysing results, and documenting evidence.
- It involves comprehensive testing and qualification activities to ensure the process is capable of consistently producing high-quality products.
Focus area:
- More broader scope that focuses on the entire process looking at critical parameters, quality attributes, and overall process performance.
Overview of Process Verification
Purpose:
- To confirm that established processes continue to operate in a state of control.
- Its focus is on the ongoing control of established processes against quality standards and specifications.
Timing:
- Conducted after the process has been validated and is in routine production.
- The activity is performed regularly throughout the lifecycle of the process.
Activities involved:
- Implementing ongoing monitoring and verification activities including regular assessments, data collection, and periodic reviews to ensure the process remains effective.
Focus area:
- Focuses on specific elements or parameters within the established process with ongoing monitoring of critical parameters and periodic reviews of process performance.
In summary, process validation is a comprehensive, one-time activity conducted during the introduction or modification of a process, manufacturing site, or equipment. It aims to establish that the entire process is capable of consistently producing high-quality products.
On the other hand, process verification is an ongoing activity that ensures the established, validated processes continue to operate within specified parameters during routine production. Both processes are crucial for maintaining product quality and compliance with regulatory standards over time.