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.
Risk minimisation measures aim to optimise the safe and effective use of a medicinal product throughout its life cycle.
From 8 to 10 February 2017, the PIC/S Committee and PIC/S Executive Bureau meetings took place in Geneva, Switzerland
Global regulatory collaboration relating to data integrity remains a priority for MHRA and its international partners.
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.
Over the past few years we have seen our events grow in popularity; we have gone from 6 a year to over 30!
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 …
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 …
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.
Eighteen months have passed since the MHRA published its GMP data integrity guidance. Since then we have seen pharmaceutical industry make significant effort to implement the guidance globally. It has been encouraging to see industry stakeholders and regulatory partners adopting …
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