Operational Transformation Programme – an Inspectorate view
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
An Inspector Calls: Part 2, GMP Short Notice and Unannounced Inspections cont
Posted by:
Tracy Moore, Posted on:
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Categories:
Compliance matters, Good manufacturing practice, Inside the Inspectorate
Potential patient safety issues, serious breaches of GMP or suspected criminal activity frequently trigger short notice or unannounced inspections
Looking for a New Challenge in 2018?
Posted by:
Mark Birse, Posted on:
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Categories:
Compliance matters, Good clinical practice, Good distribution practice, Good manufacturing practice, Good pharmacovigilance practice, Inside the Inspectorate, Wider MHRA
Whilst we progress our latest recruitment campaign for GMDP Inspectors, Ian Holloway reflects on 30 years of working for the Medicines Regulator.
MHRA Inspectorate Organogram
We have today updated the sidebar of the MHRA Inspectorate Blog to provide access to the MHRA Inspectorate organogram.
Losing GSi – MHRA emails are changing
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
Overview of compliance management escalation processes used by the GMP Inspectorate
Posted by:
Alan Moon, Posted on:
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Categories:
Compliance matters, Events and symposia, Good distribution practice, Good manufacturing practice, Inside the Inspectorate
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 …
Who inspects the Inspectors? (Part II)
Posted by:
Ian Jackson, Posted on:
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Categories:
Compliance matters, Good clinical practice, Good distribution practice, Good laboratory practice, Good manufacturing practice, Good pharmacovigilance practice, Inside the Inspectorate, Wider 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.
The 2017 Orange and Green Guides
Posted by:
Mark Birse, Posted on:
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Categories:
Compliance matters, Good distribution practice, Good manufacturing practice, Inside the Inspectorate
The 2017 Orange and Green Guides are almost ready for publication.
Who inspects the Inspectors?
Posted by:
Ian Jackson, Posted on:
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Categories:
Compliance matters, Good manufacturing practice, Inside the Inspectorate
In October 2015 the MHRA was audited under the Joint Audit Programme (JAP) for EEA GMP Inspectorates.
Joining and working for the Inspectorate
Posted by:
Philip Rose, Posted on:
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Categories:
Compliance matters, Good clinical practice, Good distribution practice, Good laboratory practice, Good manufacturing practice, Good pharmacovigilance practice, Inside 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 …
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