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How do you review and update your GDP transport validation plan and documentation?

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GDP validation of transport is a crucial step to ensure the quality and safety of your pharmaceutical products. It involves verifying that your transport processes, equipment, and personnel comply with the Good Distribution Practice (GDP) guidelines and regulations. But how do you review and update your GDP transport validation plan and documentation? In this article, we will cover six aspects that you need to consider.

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1 Scope and objectives

The first thing you need to do is to define the scope and objectives of your GDP transport validation. This means identifying what transport modes, routes, and products you need to validate, and what are the expected outcomes and benefits of the validation. You should also establish the roles and responsibilities of your validation team, and the criteria and methods for evaluating the validation results.

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Sarantis Kosmas

Business Development Director @ Strategnos | Master's in Supply Chain Management
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The key to defining the scope of a transport validation is to ensure one understands the unique permutations of the various elements within the supply chain. Furthermore prior to embarking on such an activity it is worth verifying the the equipment across the supply chain has been qualified prior to initiating a transport validation.

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2 Risk assessment

The next step is to conduct a risk assessment of your transport processes and equipment. This involves identifying and analyzing the potential hazards and sources of variation that could affect the quality and integrity of your products during transport. For example, you should consider the temperature, humidity, vibration, shock, and security risks that your products may encounter. You should also prioritize the risks based on their severity and likelihood, and define the control measures and mitigation strategies to minimize them.

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Arleen Candari

VP, Business Development, AVS Life Sciences & Founder of C&A Consulting, LLC
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Note that it is also important to perform vendor qualification on your transportation vendors and ensure protocols are in place for transporting the product. Train them on their specific activities of your validation protocol as they play a key role in the handshake handoffs that occur when receiving then delivering the product.

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3 Validation protocol

When developing a validation protocol, you should consider your scope, objectives, and risk assessment. This protocol should outline the plan and procedures for conducting the validation, including the approach and rationale, acceptance criteria and specifications, activities and tests to be performed, equipment and materials to be used, data and records to be collected and analyzed, as well as the report and documentation to be generated.

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4 Validation execution

The validation execution is the phase where you actually implement the validation protocol and perform the validation activities and tests. You should follow the protocol strictly and document every step and result. You should also monitor and record the relevant transport parameters and conditions, such as temperature, humidity, vibration, shock, and security. You should also verify that the validation equipment and materials are calibrated and maintained properly, and that the validation personnel are trained and qualified.

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Arleen Candari

VP, Business Development, AVS Life Sciences & Founder of C&A Consulting, LLC
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Also, ensure your strategy takes into consideration the necessity to perform the validation testing across the potential variations of geographical zones and times of year the testing must occur to account for weather effect on the product that has temperature specifications.

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5 Validation report

The validation report is the document that summarizes and evaluates the validation results and outcomes. It should include a validation summary, objectives, methods and procedures, data and analysis, deviations and corrective actions, conclusions and recommendations, as well as approval and signatures. Additionally, the report should be supported by validation data and records like graphs, charts, tables, certificates, and logs.

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Sarantis Kosmas

Business Development Director @ Strategnos | Master's in Supply Chain Management
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In the case of transport validation the reporting side can become quite complex, as a wide variety of temperature data will be obtained across the various routes. Ensure that the data is collected, stored and ready for analysis is key to ensuring an efficient reporting process. Additionally the raw temperature and humidity data alone is not sufficient it is critical to ensure there is an approach to effectively capture the necessary meta data about the transport system i.e. routes, vehicles, packing etc.

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6 Validation review and update

The validation review and update is the process of maintaining and improving your GDP transport validation plan and documentation. You should review and update your validation plan and documentation regularly, or whenever there are changes in your transport processes, equipment, products, or regulations. You should also conduct periodic revalidation or verification to confirm that your transport processes and equipment are still compliant and effective. You should also document any changes or revisions in your validation plan and documentation, and communicate them to your validation team and stakeholders.

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How do you review and update your GDP transport validation plan and documentation?

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1 Scope and objectives

2 Risk assessment

3 Validation protocol

4 Validation execution

5 Validation report

6 Validation review and update

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