GOV.UK
Do wholesale distributors require pharmacovigilance agreements?
Our GDP inspectors often receive queries from wholesaler distributors asking in what instances agreements are required for the purposes of fulfilling pharmacovigilance requirements.
Good pharmacovigilance practice
Too much pressure: a behavioural approach to Data Integrity (Part 2)
The first post in this series described the importance of organisational behaviour on the success of data integrity control measures. Behavioural issues are often unsuitable for technical guidance, but the Inspectorate blog provides an opportunity to address this complex issue.
Responsibilities of MAHs participating in work-sharing initiatives for additional risk minimisation measures
Risk minimisation measures aim to optimise the safe and effective use of a medicinal product throughout its life cycle.
PIC/S meeting - February 2017
From 8 to 10 February 2017, the PIC/S Committee and PIC/S Executive Bureau meetings took place in Geneva, Switzerland
Too much pressure: a behavioural approach to Data Integrity (Part 1)
Global regulatory collaboration relating to data integrity remains a priority for MHRA and its international partners.
Who inspects the Inspectors? (Part II)
In the October blog post we told you about the successful audit of the GMP Inspectorate under the JAP programme. Later that month the entire Inspectorate was assessed as part of the BEMA programme.
MHRA Events
Over the past few years we have seen our events grow in popularity; we have gone from 6 a year to over 30!
Joining and working for the Inspectorate
When I applied to join the Inspectorate I was working as a Qualified Person. I’d been on the receiving end of many inspections and thought that the role looked to be a hugely interesting one with a great amount of …
GPvP inspections of contract service providers - August 2016 update
In July 2003 the Medicines and Healthcare products Regulatory Agency (MHRA) introduced a statutory pharmacovigilance inspection programme of marketing authorisation holders (MAHs) in the United Kingdom. The revisions to the pharmacovigilance legislation implemented in 2012 are supportive of the inspection of …
PIC/S - Press release and news of MHRA hosted meetings and seminar, July 2016
Just 4 weeks ago the MHRA hosted the PIC/S Committee meeting, PIC/S Executive Bureau meeting, and PIC/S Annual Seminar at the Museum of Science and Industry (MOSI) in Manchester.