Quality Risk Management (QRM) is a requirement of Good Distribution Practice (GDP). It underpins good design and maintenance of a GDP quality system and provides an approach that enables the quality system to be safe for patients, efficient and effective through identification of risks, and facilitates proportionality of mitigation.
I joined the MHRA as a GDP Inspector in 2009. My position involves inspecting UK organizations that wholesale medicines. I previously worked in the pharmaceutical industry for 20+ years and was involved in research, development and within QA functions in manufacturing companies.
During the Covid-19 pandemic you may need to adjust how you operate. Such changes should be documented either as deviations, change controls or similar and incorporate quality risk management principles.
Theft of medicines increases risk to public health - a look at what can be done to improve distribution security standards.
Guidance and examples of data integrity issues seen on GDP inspections.
To assist wholesalers to understand areas where significant GDP failures have been observed, the GDP Inspectorate has published the inspection deficiency data for 2016.
This post describes the main issues seen when freezers are used by pharmaceutical wholesalers and provides an MHRA GDP inspectors’ view on possible ways to address them.
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About the MHRA Inspectorate Blog
This blog shares the work of the Medicines and Healthcare products Regulatory Agency (MHRA) Inspectorate, by inspectors and those the Inspectorate works with.
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- A fresh look at an old topic: Investigations in the GMDP environment
- Cross Contamination Control in Shared Facilities and Equipment. Reflection on common deficiencies and expectations as seen in recent PIC/S guidance.
- GCP Serious Breaches update
- MHRA planning for return to on-site Good Practice (GxP) inspections
- A Practical example of applying Quality Risk Management in GDP – Transportation Risks