How do you handle GMP validation changes?

1 Identify the change

The first step is to identify the nature, scope, and impact of the change. You need to determine if the change affects the quality, safety, or efficacy of the product, or if it introduces any new risks or hazards. You also need to assess if the change requires a revalidation of the entire system or a partial validation of the affected components. You can use a change control form or a risk assessment tool to document your analysis and justification.

3 Revise the validation documents

The third step is to revise the validation documents according to the change. You need to update the validation plan, protocols, reports, and records with the new or modified information. You also need to ensure that the validation documents are clear, accurate, and consistent. You can use a document control system or a version control system to track and manage the changes and revisions.

4 Perform the validation tests

The fourth step is to perform the validation tests as per the revised protocols. You need to follow the predefined procedures, instructions, and specifications for executing the tests. You also need to collect and record the validation data and results in a reliable and traceable manner. You can use a validation software or a data management system to automate and simplify the validation testing process.

5 Evaluate the validation outcomes

The fifth step is to evaluate the validation outcomes and check if they meet the acceptance criteria. You need to analyze the validation data and results and verify if they demonstrate the performance, functionality, and compliance of the system. You also need to identify any deviations, errors, or failures that occurred during the validation tests and investigate their root causes and corrective actions. You can use a validation report or a summary report to document your evaluation and findings.

6 Implement the change

The final step is to implement the change and release the system for use. You need to ensure that the change is properly communicated, approved, and documented by the relevant stakeholders and authorities. You also need to ensure that the change is integrated with the existing system and that the system operates as intended and expected. You can use a change management system or a quality management system to monitor and control the change implementation and effectiveness.

7 Here’s what else to consider

This is a space to share examples, stories, or insights that don’t fit into any of the previous sections. What else would you like to add?