Wednesday 19 August 2020

A Practical example of applying Quality Risk Management in GDP – Transportation Risks

This is about identifying and defining the risks. The MHRA write:

“Many companies present such summaries as a spreadsheet which assists communication, an essential part of QRM. The summary should be regularly re-evaluated and potential changes assessed during quality management review meetings. It is rare to find sound scientific justification for acceptance of a load subject to an excursion, and in the uncommon instances where a supplier or customer contacts the marketing authorization holder for stability information, it is often not directly comparable to the excursion experienced. Unfortunately, the most common reason for accepting a consignment with a temperature excursion is purely commercial, which may put patients at risk and undermines any risk management carried out by the company.

In some cases of quality risk management, attempts were made to inappropriately apply mean kinetic temperature to underestimate impact rather than develop good control and preventive measures.”

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (

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