This post provides some background information to the aims of the operational transformation programme and how the inspectorate is rising to the challenge.
Whilst we progress our latest recruitment campaign for GMDP Inspectors, Ian Holloway reflects on 30 years of working for the Medicines Regulator.
In the coming weeks, you will notice that it’s much quieter than usual on the MHRA Inspectorate blog. It’s because between midnight on Friday, 21 April and the general election on 8 June is the pre-election period.
From 10 April, we are removing .gsi from our email addresses. Technology has changed a lot since the introduction of the Government Secure Intranet (GSi) in 1996
We currently have a vacancy for a pharmaceutical assessor to join the Defective Medicines Report Centre (DMRC) team, working closely with the Inspectorate as part of the Inspection Enforcement and Standards Division of the MHRA.
In the October blog post we told you about the successful audit of the GMP Inspectorate under the JAP programme. Later that month the entire Inspectorate was assessed as part of the BEMA programme.
6 top tips for applicants submitting a Manufacturing Authorisation application or variation
Over the past few years we have seen our events grow in popularity; we have gone from 6 a year to over 30!
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.
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.