How do you validate and verify during audits?

1 Understand the difference

Validation and verification are often confused, but they have distinct meanings and purposes in GMP. Validation is the process of proving that your methods, processes, or systems can consistently achieve the intended results under normal conditions. Verification is the process of confirming that your methods, processes, or systems are operating as expected and meeting the specified requirements. Validation is usually done before or during the implementation of a new or changed method, process, or system, while verification is done periodically or after any changes to ensure ongoing compliance.

2 Plan your validation and verification activities

Before you conduct any validation or verification activities, you need to have a clear plan that defines the scope, objectives, criteria, methods, responsibilities, and documentation of the tasks. You should also identify the risks and potential sources of variation that could affect the quality of your products or processes, and how you will mitigate them. A validation or verification plan should be based on a sound scientific rationale and follow the relevant guidelines and regulations for your industry and product type. You should also consult with your internal and external stakeholders, such as quality assurance, regulatory affairs, customers, and auditors, to ensure alignment and acceptance of your plan.

3 Execute your validation and verification activities

Once you have a plan, you need to execute it according to the defined procedures and protocols. You should use appropriate equipment, materials, standards, and controls to perform the validation or verification tests, and record the data and results accurately and objectively. You should also monitor and document any deviations, anomalies, or issues that occur during the execution, and how you resolve them. You should ensure that your validation or verification activities are performed by qualified and trained personnel, and that they are supervised and reviewed by independent and authorized personnel.

4 Analyze and report your validation and verification results

After you complete your validation or verification activities, you need to analyze and report the results to determine if they meet the acceptance criteria and objectives. You should use statistical methods and tools to evaluate the data and results, and identify any trends, outliers, or discrepancies. You should also compare the results with the expected outcomes and the historical data, and explain any differences or deviations. You should prepare a validation or verification report that summarizes the findings, conclusions, and recommendations, and that includes all the relevant documentation, such as protocols, data, results, deviations, corrective actions, and approvals.

5 Implement and follow up your validation and verification actions

Based on the validation or verification report, you need to implement any actions that are required to improve or maintain the quality of your products or processes. These could include corrective actions, preventive actions, changes, improvements, or optimizations. You should also follow up on the effectiveness and impact of these actions, and verify that they are implemented correctly and consistently. You should update your validation or verification status and documentation accordingly, and communicate the results and actions to your stakeholders and auditors.

6 Prepare for validation and verification audits

Validation and verification audits are conducted by internal or external auditors to assess the compliance and performance of your validation and verification activities. They can be part of a routine or a specific audit, and they can cover different aspects, such as planning, execution, analysis, reporting, implementation, and follow up. To prepare for validation and verification audits, you should ensure that your validation and verification activities are aligned with the GMP standards and expectations, and that you have all the necessary documentation and evidence to support them. You should also be ready to explain and justify your validation and verification methods, results, and actions, and to demonstrate your competence and knowledge in this area.

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?