MHRA Inspectorate

The GDP Inspectorate team are hiring

Posted by: Claire Glenister, Bernadette Wilson and petercoombs, Posted on: 21 May 2018 - Categories: Compliance matters, Good distribution practice, Inside the Inspectorate, Wider MHRA

The GDP Inspectorate are currently recruiting, find out more about the role and how to apply.

PIC/S press release following April 2018 meeting

Posted by: Mark Birse, Posted on: 9 May 2018 - 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.

Obtaining medicines for wholesale using prescriptions and an important update on attempted thefts from warehouses

Posted by: Tony Orme, Posted on: 3 May 2018 - Categories: Compliance matters, Good distribution practice

The GDP inspectorate has seen a growing number of false NHS and private prescriptions being used to obtain medicines from Marketing Authorisation Holders for the onward wholesale.

VHP (Vapour Hydrogen Peroxide) Fragility

Posted by: andrewhopkins, Posted on: 20 April 2018 - Categories: Compliance matters, Good manufacturing practice

This post provides guidance around the use of VHP for sterilization purposes

Guidance around the urgent supply of unlicensed medicines imported out-of-hours by UK hospitals.

Posted by: grahammatthews, Posted on: 3 April 2018 - Categories: Compliance matters, Good distribution practice, Good manufacturing practice

This blog provides guidance around the urgent supply of unlicensed medicines that have needed to be imported out of hours by UK hospitals.

Operational Transformation Programme – an Inspectorate view

Posted by: Michelle Yeomans, Posted on: 22 March 2018 - Categories: Inside the Inspectorate, Wider MHRA

This post provides some background information to the aims of the operational transformation programme and how the inspectorate is rising to the challenge.

MHRA’s GXP data integrity guide published

Posted by: Tracy Moore, Posted on: 9 March 2018 - 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: 2 March 2018 - 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.

MHRA Pharmacovigilance Symposium 2018

Posted by: clairelongman, Posted on: 23 February 2018 - Categories: Compliance matters, Events and symposia, Good pharmacovigilance practice

Find out here how to register for the 2018 pharmacovigilence symposium which will include topics such as inspection findings and trends, a talk on service providers and outsourcing and areas of change such as signal detection in Eudravigilance.

GMDP Symposium 2017 - GDP Days

Posted by: Bernadette Wilson, Posted on: 19 February 2018 - Categories: Compliance matters, Events and symposia, Good distribution practice

The focus of the 2017 GDP Symposium was risky business! This year the complimentary themes of Risk Management and Transportation ran throughout the various sessions at the event.

Blog MHRA Inspectorate

I don't believe it!