Guidance and examples of data integrity issues seen on GDP inspections.
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.
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.