David Churchward

I am an Expert GMP Inspector in the Medicines and Healthcare Products Regulatory Agency. I represent the MHRA at national and international level, to develop technical and legislative guidance relating to GMDP inspections. Alongside my colleagues in the MHRA’s GMDP Inspectorate I work to ensure that the medicines supplied to the EU are of the required quality.

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.

MHRA data integrity guidance: 18 months on

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 …