This post provides some background information to the aims of the operational transformation programme and how the inspectorate is rising to the challenge.
Inside the Inspectorate
Potential patient safety issues, serious breaches of GMP or suspected criminal activity frequently trigger short notice or unannounced inspections
Whilst we progress our latest recruitment campaign for GMDP Inspectors, Ian Holloway reflects on 30 years of working for the Medicines Regulator.
We have today updated the sidebar of the MHRA Inspectorate Blog to provide access to the MHRA Inspectorate organogram.
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
At the GMDP Symposium 2016, Andrew Hopkins and I gave a presentation about the Inspection Action Group (IAG) and Compliance Management Team (CMT), to highlight the systems and processes in place for when compliance issues are identified at manufacturing and …
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.
The 2017 Orange and Green Guides are almost ready for publication.
Traditionally, GDP (Good Distribution Practice) inspectors visit sites to confirm that holders of Wholesale Dealer’s Authorisations (WDA) are compliant with the requirements of legislation.
In October 2015 the MHRA was audited under the Joint Audit Programme (JAP) for EEA GMP Inspectorates.