How do you maintain GDP standards for temperature-controlled products?

1 Define the temperature range

The first step to maintain GDP standards for temperature-controlled products is to define the temperature range that is suitable for each product. This depends on the product specifications, the stability data, and the regulatory requirements. You should consult the product information, the manufacturer, and the relevant authorities to determine the appropriate temperature range. You should also document and communicate this information to all the parties involved in the distribution process.

2 Monitor and record the temperature

The second step to maintain GDP standards for temperature-controlled products is to monitor and record the temperature of the products during storage, transport, and delivery. You should use calibrated and validated temperature monitoring devices, such as sensors, loggers, or indicators, to measure and record the temperature of the products and the environment. You should also establish and follow procedures for checking, downloading, and reviewing the temperature data. You should keep the records for at least one year or as required by the regulations.

3 Control and mitigate the temperature deviations

The third step to maintain GDP standards for temperature-controlled products is to control and mitigate the temperature deviations that may occur during the distribution process. You should use appropriate packaging, containers, and vehicles that can protect the products from temperature fluctuations, shocks, and damages. You should also follow the instructions and precautions provided by the manufacturer or the supplier for handling and loading the products. You should have contingency plans and corrective actions in case of temperature deviations or emergencies. You should report and investigate any deviations and take necessary measures to prevent recurrence.

4 Train and educate the staff

The fourth step to maintain GDP standards for temperature-controlled products is to train and educate the staff who are involved in the distribution process. You should ensure that they are aware of the importance and the requirements of GDP for temperature-controlled products. You should provide them with adequate and updated training on the policies, procedures, and practices of GDP for temperature-controlled products. You should also assess their competence and performance regularly and provide feedback and support.

5 Audit and review the process

The fifth step to maintain GDP standards for temperature-controlled products is to audit and review the process periodically. You should conduct internal and external audits to verify the compliance and effectiveness of the GDP system for temperature-controlled products. You should also review the process and the performance indicators regularly and identify any gaps, risks, or opportunities for improvement. You should implement and monitor any changes or improvements that are needed to ensure the continuous improvement of the GDP system for temperature-controlled products.

6 Update and comply with the regulations

The sixth and final step to maintain GDP standards for temperature-controlled products is to update and comply with the regulations that apply to your products and your region. You should keep yourself informed of the latest changes and developments in the GDP regulations and guidelines for temperature-controlled products. You should also ensure that you meet the legal and ethical obligations and responsibilities of a responsible person for GDP. You should also cooperate and collaborate with the authorities and the stakeholders to ensure the quality, safety, and efficacy of the temperature-controlled products.

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?