How do you conduct a GDP qualification for a new storage facility?

1 Define the scope

The first step is to define the scope of the qualification, which includes identifying the products, processes, equipment, and areas that will be stored and handled in the facility. You also need to determine the acceptance criteria, the documentation requirements, and the roles and responsibilities of the personnel involved. The scope should be documented in a qualification plan, which serves as the basis for the qualification activities.

2 Perform the design qualification

The next step is to perform the design qualification (DQ), which involves reviewing the design and layout of the facility, as well as the technical specifications and drawings of the equipment and systems. The DQ ensures that the facility is designed in accordance with the regulatory and operational requirements, and that it can accommodate the intended products and processes. The DQ should be documented in a design qualification report, which summarizes the results and findings of the review.

4 Execute the operational qualification

The fourth step is to execute the operational qualification (OQ), which involves verifying and validating the performance and functionality of the equipment and systems in the facility. The OQ ensures that the equipment and systems can operate consistently and reliably under normal and abnormal conditions, and that they meet the predefined acceptance criteria. The OQ should be documented in an operational qualification report, which details the verification and validation methods, data, and results.

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?