How do you verify GMP equipment and methods?

1 Define your requirements

The first step is to define your requirements for the equipment and methods you want to verify. You need to specify the intended use, performance criteria, acceptance criteria, and validation protocol for each equipment and method. You also need to identify the relevant GMP standards, regulations, and guidelines that you need to comply with. You can use tools such as risk analysis, gap analysis, and design review to help you define your requirements.

2 Select your verification methods

The second step is to select the appropriate verification methods for your equipment and methods. Verification methods are the techniques and procedures that you use to confirm that the equipment and methods meet your requirements. You can use different types of verification methods, such as testing, inspection, calibration, qualification, or verification of design. You need to select the verification methods that are suitable for the level of complexity, risk, and criticality of your equipment and methods.

3 Prepare your verification plan

The third step is to prepare your verification plan for your equipment and methods. Your verification plan is a document that describes how you will conduct the verification activities, including the scope, objectives, responsibilities, resources, schedule, and documentation. Your verification plan should also include the verification criteria, methods, procedures, and protocols that you will use. You need to ensure that your verification plan is aligned with your requirements and follows the GMP principles and practices.

4 Execute your verification activities

The fourth step is to execute your verification activities for your equipment and methods. You need to follow your verification plan and perform the verification methods that you have selected. You need to collect and record the verification data and results, and compare them with your acceptance criteria. You need to document any deviations, non-conformities, or issues that you encounter during the verification activities, and implement corrective and preventive actions as needed.

5 Review your verification results

The fifth step is to review your verification results for your equipment and methods. You need to analyze and evaluate the verification data and results, and verify that they meet your requirements and expectations. You need to verify that your equipment and methods are fit for purpose, reliable, consistent, and compliant with the GMP standards and regulations. You need to document your verification results and conclusions in a verification report.

6 Maintain your verification status

The sixth step is to maintain your verification status for your equipment and methods. You need to ensure that your equipment and methods remain in a verified state throughout their lifecycle. You need to monitor and control their performance, quality, and compliance, and perform periodic verification activities as required. You need to document any changes, modifications, or improvements that you make to your equipment and methods, and verify their impact on your verification status.

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?