2/3 March 2022
Quality Risk Management (QRM) is a fundamental requirement in the Good Distribution Practice (GDP) environment. It is applicable to a variety of activities and processes, such as temperature mapping studies, supplier qualification, deviations, and change control.
In this context, a new post, entitled "A Practical example of applying Quality Risk Management in GDP - Transportation Risks", has been published in the Medicines and Healthcare products Regulatory Agency (MHRA) Inspectorate blog. The blog entry written by Terry Madigan was posted on 15 July 2020.
The article starts with the question "What is your biggest GDP risk?" and replies directly "If you had to think about the answer, then it is likely that you haven’t given it much thought." The author then clarifies, that the blog entry focuses "on QRM as it applies to transportation which remains a significant weakness for many wholesalers, especially those that do not own their own fleet."
Afterward, the following aspects are addressed:
Furthermore, the article describes the MHRA expectations in regard to control and monitoring of temperature during transportation. References are made to the European Guidelines on Good Distribution Practice for Medicinal Products.
Finally, the article mentions common weaknesses seen with GDP quality risk management, such as "Risk assessments are not reviewed" or "QRM is not understood by managers". Whereas, good practices seen are, for example, that "QRM is fully integrated throughout the quality system" and "the QRM processes used are easy to understand and apply".
To read the full article, please see the MHRA Inspectorate blog.