How do you evaluate the performance and suitability of OQ tools and methods?

1 OQ tools and methods

OQ tools and methods are the means by which you test the system's functionality, reliability, security, and compliance. They can include software, hardware, scripts, protocols, checklists, procedures, and test cases. Depending on the system's complexity and risk level, you may use different types of tools and methods, such as manual, automated, or hybrid. The choice of OQ tools and methods should be based on a risk assessment and a validation plan.

2 Evaluation criteria

When evaluating the performance and suitability of OQ tools and methods, accuracy, completeness, repeatability, traceability, and compliance should all be taken into consideration. Accuracy requires that the tools and methods produce consistent and correct results that match the system specifications and requirements. Completeness means that all relevant aspects of the system's functionality must be covered, including normal, abnormal, and boundary conditions. Repeatability requires that the same results are produced under the same conditions and inputs. Traceability links the tools and methods to the system specifications and requirements, while compliance follows applicable regulations, standards, and guidelines for CSV such as GAMP 5, 21 CFR Part 11, and EU Annex 11. The test results should also be documented and recorded.

3 OQ documentation

OQ documentation is essential for providing evidence that the system functions as expected in both normal and abnormal conditions. This documentation should include an OQ protocol, which outlines the scope, objectives, approach, responsibilities, acceptance criteria, and procedures for OQ testing. Additionally, an OQ test cases document should be included, detailing the test scenarios, inputs, outputs, expected results, and actual results for each OQ test. Lastly, an OQ report should be included to summarize the OQ test results, deviations, corrective actions, and conclusions.

4 OQ review and approval

OQ review and approval is the process of verifying that the OQ tools and methods are effective and suitable, as well as that the OQ documentation is complete and accurate. This includes checking the OQ protocol against the validation plan and system specifications, reviewing the OQ test cases for accuracy, completeness, repeatability, traceability, and compliance, evaluating the OQ test results for conformity with the acceptance criteria and system specifications, identifying and resolving any deviations, errors, or failures that occurred during OQ testing, and approving the OQ report and signing off the OQ phase.

5 OQ best practices

To ensure that the OQ tools and methods are effective and suitable, and that the OQ documentation is complete and accurate, you should follow some best practices. These include planning and designing the OQ tools and methods based on a risk assessment and a validation plan, as well as using appropriate tools and methods for the system's complexity and risk level, and validating them before use. Additionally, it is important to perform OQ testing in a controlled and representative environment that simulates the operational conditions. Furthermore, you should document and record the OQ test results and any deviations, errors, or failures that occurred during OQ testing, then review and approve the OQ documentation by qualified and independent personnel. Overall, OQ is an essential part of CSV for the pharmaceutical industry; by evaluating the performance and suitability of OQ tools and methods, you can ensure that the system performs as expected under normal and abnormal conditions, while also meeting regulatory requirements.

6 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?