What are the best ways to solve GMP validation and verification issues?

1 Define the scope and objectives

The first step to solve GMP validation and verification issues is to define the scope and objectives of the project. This means identifying what needs to be validated or verified, why, how, and by whom. You should also establish the acceptance criteria, the risk level, and the regulatory expectations for the product. By defining the scope and objectives clearly, you can avoid unnecessary work, reduce errors, and ensure alignment with the GMP principles.

2 Plan and design the activities

The next step is to plan and design the activities that will be performed to validate or verify the product. This includes choosing the appropriate methods, tools, equipment, and personnel for the task. You should also determine the sampling plan, the testing protocol, the data collection and analysis methods, and the documentation format. By planning and designing the activities carefully, you can optimize the resources, ensure consistency, and achieve the desired outcomes.

3 Execute and monitor the activities

The third step is to execute and monitor the activities according to the plan and design. This means following the instructions, procedures, and standards that have been established for the validation or verification process. You should also record the results, observations, deviations, and corrective actions that occur during the execution. By executing and monitoring the activities diligently, you can ensure accuracy, reliability, and traceability of the data.

4 Evaluate and report the results

The fourth step is to evaluate and report the results of the validation or verification activities. This means comparing the data with the acceptance criteria, identifying any gaps, issues, or failures, and drawing conclusions and recommendations. You should also prepare a comprehensive and clear report that summarizes the objectives, methods, results, and conclusions of the validation or verification project. By evaluating and reporting the results objectively, you can demonstrate compliance, effectiveness, and improvement of the product.

5 Review and approve the report

The fifth step is to review and approve the report of the validation or verification project. This means checking the quality, completeness, and accuracy of the report, verifying that it meets the regulatory and internal requirements, and addressing any feedback or comments. You should also obtain the approval from the authorized personnel, such as the quality assurance manager, the project manager, or the client. By reviewing and approving the report thoroughly, you can ensure accountability, transparency, and credibility of the validation or verification process.

6 Maintain and update the validation or verification status

The final step is to maintain and update the validation or verification status of the product. This means keeping track of any changes, modifications, or enhancements that affect the product, such as new equipment, processes, materials, or regulations. You should also perform periodic revalidation or re-verification activities to confirm that the product still meets the specifications and requirements of GMP. By maintaining and updating the validation or verification status regularly, you can ensure continuous quality, safety, and consistency of the product.

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?