VHP (Vapour Hydrogen Peroxide) Fragility
This post provides guidance around the use of VHP for sterilization purposes
Good manufacturing practice
Guidance around the urgent supply of unlicensed medicines imported out-of-hours by UK hospitals.
Posted by:
grahammatthews, Posted on:
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Categories:
Compliance matters, Good distribution practice, Good manufacturing practice
This post provides guidance around the urgent supply of unlicensed medicines that have needed to be imported out of hours by UK hospitals.
MHRA’s GXP data integrity guide published
Posted by:
Tracy Moore, Posted on:
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Categories:
Compliance matters, Good clinical practice, Good distribution practice, Good laboratory practice, Good manufacturing practice, Good pharmacovigilance practice
The MHRA’s GXP data integrity guide has been published today.
Out of Specification Guidance
Posted by:
Lesley Graham, Posted on:
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Categories:
Compliance matters, Good laboratory practice, Good manufacturing practice
The issue faced when dealing with out of specification (OOS) results is as much a challenge now as it ever was. This post provides some guidance on how to handle OOS results.
GMDP Symposium 2017- GMP Days
Posted by:
grahamcarroll, Posted on:
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Categories:
Compliance matters, Events and symposia, Good manufacturing practice
The 2017 GMP Symposium was the riskiest ever! This year the theme of Risk Management ran throughout the various sessions at the event.
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.
2018 MHRA Laboratories Symposium
Posted by:
Lynsay Hunter, Posted on:
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Categories:
Compliance matters, Events and symposia, Good clinical practice, Good laboratory practice, Good manufacturing practice
The Inspectorate laboratories group conducts a diverse number of inspections both internationally and across the United Kingdom.
EU-FDA mutual recognition of inspections of medicines manufacturers enters operational phase
Posted by:
Ian Rees and Mark Birse, Posted on:
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Categories:
Compliance matters, Good clinical practice, Good distribution practice, Good laboratory practice, Good manufacturing practice
Today marks the start of the operational phase of the EU-FDA mutual recognition agreement
International regulators inspecting in the UK
Posted by:
Mark Birse, Posted on:
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Categories:
Compliance matters, Good clinical practice, Good distribution practice, Good laboratory practice, Good manufacturing practice, Good pharmacovigilance practice
The MHRA has seen an increasing number of inspections being conducted in both the UK and the rest of the EU by regulators from other countries.
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