Being signed up to the OECD Mutual Acceptance of Data agreement is anything but MAD!
Why it's a good idea for the UK to be part of the OECD MAD framework
Good laboratory practice
MHRA Laboratories Symposium 2019 ... plus GXP mailbox update
Posted by:
Martin Reed, Posted on:
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Categories:
Events and symposia, Good clinical practice, Good laboratory practice, Good manufacturing practice
The MHRA Laboratories Symposium will be held on 13 March 2019 at the Novotel in London. Also ... we have recently changed the contact email address for the laboratories inspection group from glp@mhra.gov.uk to gxplabs@mhra.gov.uk
It pays to be compliant!
Posted by:
Michelle Yeomans, Posted on:
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Categories:
Compliance matters, Good clinical practice, Good distribution practice, Good laboratory practice, Good manufacturing practice, Good pharmacovigilance practice
In a bid to drive improved compliance and to cover the cost of managing more resource-intensive cases, the Inspectorate intends to apply the existing office-based assessment fee more broadly.
Making GCP Training Relevant and Applicable: It’s Not Just for Clinical Staff
Posted by:
Jason Wakelin-Smith, Posted on:
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Categories:
Compliance matters, Good clinical practice, Good laboratory practice
We often receive questions about GCP training for laboratory staff, which suggests that this is a topic that causes quite a few laboratories issues!
Process Licensing Office joins the Inspectorate
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, Inside the Inspectorate
The Process Licensing Office has today joined the Inspectorate to become the Inspectorate & Process Licensing Group.
PIC/S press release following April 2018 meeting
Posted by:
Mark Birse, Posted on:
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Categories:
Good clinical practice, Good distribution practice, Good laboratory practice, Good manufacturing practice, Good pharmacovigilance practice, Inside the Inspectorate
From 16 to 18 April 2018 the PIC/S Committee and PIC/S Executive Bureau meetings took place in Geneva, Switzerland.
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.
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
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