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Looking for a New Challenge in 2018?
Whilst we progress our latest recruitment campaign for GMDP Inspectors, Ian Holloway reflects on 30 years of working for the Medicines Regulator. My name is Ian Holloway and I am a senior GMDP...
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An Inspector Calls: Part 2, GMP Short Notice and Unannounced Inspections cont
Last year, I wrote about some of the reasons that trigger short notice or unannounced inspections to occur. The previous post centred around our ability to manage resource effectively and to highlight...
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MHRA GPvP Inspectorate Guide to Marketing Authorisation Holder Considerations...
The pharmacovigilance systems of marketing authorisation holders are often dependent on multiple third parties; extensive outsourcing and partnering is a feature of the pharmaceutical industry as much...
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GMDP Symposium 2017- GMP Days
My name is Graham Carroll and in August 2017, I took over from Michelle Yeomans (formerly Rowson) as one of the three GMDP Operations Managers. As part of this I inherited overall responsibility for...
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GMDP Symposium 2017 - GDP Days
My name is Bernadette Wilson, I’m a GDP Inspector, and I was a key member of the team which led the organisation and delivery of the MHRA GMDP 2017 Symposium. I am pleased to share the highlights of...
View ArticleMHRA Pharmacovigilance Symposium 2018
Do you want to hear about the latest MHRA pharmacovigilance inspection findings and trends, have an opportunity to put your questions directly to the inspectors and understand which topics the...
View ArticleOut of Specification Guidance
The issue faced when dealing with out of specification (OOS) results is as much a challenge now as it ever was. Without doubt the most common deficiency raised, is the one where the OOS result has been...
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MHRA’s GXP data integrity guide published
The MHRA’s GXP data integrity guide has been published today. ‘GXP’ refers to the various good practices regulated by the UK MHRA, including the Good Laboratory Practice Monitoring Authority (GLPMA)....
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Operational Transformation Programme – an Inspectorate view
You may have already heard about the MHRA Operational Transformation Programme (OTP) through taking part in a customer survey, attended MHRA symposia, participated in a stakeholder meeting or...
View ArticleGuidance around the urgent supply of unlicensed medicines imported...
Over the past few months there have been a few incidents where urgent supplies of unlicensed medicines have needed to be imported out-of-hours by UK hospitals. Under normal circumstances hospitals may...
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