MHRA Inspectorate

Out of Specification Guidance

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.

GMDP Symposium 2017- GMP Days

Posted by: grahamcarroll, Posted on: 5 February 2018 - 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.

MHRA GPvP Inspectorate Guide to Marketing Authorisation Holder Considerations for Agreements with Pharmacovigilance System Service Providers

Posted by: joannaharper, Posted on: 22 January 2018 - Categories: Compliance matters, Good pharmacovigilance practice

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 as any other. This blog expands upon the areas identified as problematic for MAHs and service providers and provides points to consider when producing contracts and agreements text.

An Inspector Calls: Part 2, GMP Short Notice and Unannounced Inspections cont

Posted by: Tracy Moore, Posted on: 9 January 2018 - 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: 21 December 2017 - 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.

GDP Inspection Deficiency Data for 2016

Posted by: Madeleine Ault, Terry Madigan and Peter Brown, Posted on: 13 December 2017 - Categories: Compliance matters, Good distribution practice

To assist wholesalers to understand areas where significant GDP failures have been observed, the GDP Inspectorate has published the inspection deficiency data for 2016.