GCP Inspections: Expectations and the dos and don’ts for hosting

On 10 March 2020 the MHRA posted the expectations of GCP inspections in the blog of the MHRA inspectorate.

GCP inspections and how they are conducted has evolved over the years and has had to, due to the increased complexity of trials, organisations, implementation of electronic clinical trial systems and the development of technology. No longer are trial teams based in one office with a paper trial master file (TMF). Inspections can be challenging for all involved and issues have often been encountered during the inspection conduct to do with TMF access and navigation, document request provision and sometimes simply finding the right person to answer a particular question. This can be frustrating for both parties and in some cases can lead to the extension of the inspection. It’s important to remember inspectors are only onsite for a short amount of time to understand your processes and procedures. The inspectors aren’t there to try and catch you out – it’s your opportunity to demonstrate your compliance to them. Inspectors will always be open and honest, and we expect the organisations we inspect to behave in the same way. The ultimate aim of both parties at the inspection is the same; to ensure trial participant safety and that new products are released based on robust data.

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