Good pharmacovigilance practice

Too much pressure: a behavioural approach to Data Integrity (Part 2)

Chemist wearing safety glasses and using a tablet

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.

Who inspects the Inspectors? (Part II)

Diagram demonstrating that factors such as policy. standards, control, regulations and laws are all building blocks for compliance

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.

Joining and working for the Inspectorate

Reaching for the sky

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

Jigsaw piece with the word outsourcing

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

PIC/S Seminar Delegates

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.