The good manufacturing practice (GMP) Inspectorate performs a varied role in ensuring both medicines and bloods are available and are of the right quality using a risk-based inspection programme. A programme for the inspection of manufacturer and wholesale dealer licence …
The trial master file (TMF) is the collection of essential documents which allows the conduct of a clinical trial to be reconstructed and evaluated. It is basically the story of how the trial was conducted and managed. This blog highlights …
We have recently had a number of situation where importers of unlicensed medicines have attempted to notify MHRA of centrally authorised products for import as unlicensed medicines. This is not appropriate, as these are not unlicensed medicines and should be distributed …
...may also require periodic checks, such as equipment performance. Specifying exact time intervals (eg ‘every 60 minutes’) may result in an incentive for staff to ‘back date’ the time of...
A highlight of our work is when we get to engage with you through our symposia. It is a rewarding opportunity for us to keep many hundreds of you – our stakeholders - up to date with the latest regulatory …
Data integrity is fundamental in a pharmaceutical quality system which ensures that medicines are of the required quality.
Our inspectors have a direct impact on the safety and quality of the medicines that are taken by thousands of patients every day. We currently have some fantastic career opportunities available to join our team.
A large part of our role in the MHRA inspectorate involves engaging with our stakeholders. Keeping you informed of the latest changes to regulatory thinking and changes in guidance and requirements is crucial in our mission.
