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MHRA Events
MHRA Events
Over the past few years we have seen our events grow in popularity; we have gone from 6 a year to over 30!
Joining and working for the Inspectorate
When I applied to join the Inspectorate I was working as a Qualified Person. I’d been on the receiving end of many inspections and thought that the role looked to be a hugely interesting one with a great amount of …
What We Do: Veterinary Medicines
The MHRA GMDP Inspection Teams work closely with the Veterinary Medicines Directorate (VMD) Inspection Teams to ensure that manufacturers and distributors of Veterinary Medicinal Products (VMPs) are inspected appropriately and to the correct standards.
GPvP inspections of contract service providers - August 2016 update
In July 2003 the Medicines and Healthcare products Regulatory Agency (MHRA) introduced a statutory pharmacovigilance inspection programme of marketing authorisation holders (MAHs) in the United Kingdom. The revisions to the pharmacovigilance legislation implemented in 2012 are supportive of the inspection of …
DMRC Reporting – Do’s and Don’ts
Following on from the previous DMRC overview post, here are some Do’s (What, When & How) for reporting defects to the DMRC, and also some Don'ts to avoid.
PIC/S - Press release and news of MHRA hosted meetings and seminar, July 2016
Just 4 weeks ago the MHRA hosted the PIC/S Committee meeting, PIC/S Executive Bureau meeting, and PIC/S Annual Seminar at the Museum of Science and Industry (MOSI) in Manchester.
Clinical Trials Regulations – have your say
There are currently four consultations on guidance documents that have been developed in preparation for the implementation of the Clinical Trial Regulation (EU) No 536/2014. The MHRA GCP Inspectorate encourages you to take time to review these.
2016 MHRA GLP and GCP Laboratories Symposium
On 22nd September 2016 the MHRA Inspectorate will be holding another GLP and GCP Laboratories Symposium.
MHRA data integrity guidance: 18 months on
Eighteen months have passed since the MHRA published its GMP data integrity guidance. Since then we have seen pharmaceutical industry make significant effort to implement the guidance globally. It has been encouraging to see industry stakeholders and regulatory partners adopting …
Temperature mapping – an introduction.
GDP Guidelines Chapter 3.2.1 “An initial temperature mapping exercise should be carried out on the storage area before use, under representative conditions. Temperature monitoring equipment should be located according to the results of the mapping exercise, ensuring that monitoring devices …
ePRO – An Inspector’s Perspective
As with most activities in clinical trials, the development of electronic systems is playing an increasing role in methods for data collection. As inspectors we are therefore continually seeing new systems while out and about on inspection, and adapting our …