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MHRA Inspectorate
David Churchward presenting at the MHRA GMDP Symposia

David Churchward

Deputy Unit Manager, Inspectorate Strategy and Innovation
I have been a GMP inspector with the UK MHRA since 2004 and am currently responsible for the strategic direction of the GxP inspectorate.
My role is focused on international networks, harmonisation and innovative regulatory approaches to support new technologies.

MHRA planning for return to on-site Good Practice (GxP) inspections

Posted by: , Posted on: - Categories: Compliance matters, Good clinical practice, Good distribution practice, Good laboratory practice, Good manufacturing practice, Good pharmacovigilance practice
Virus Particles

On 23rd March 2020 MHRA I published a post outlining changes to MHRA’s GxP inspection programme during the COVID19 outbreak. This enabled industry and the NHS to focus on medicine supply and delivery of healthcare in support of the COVID-19 pandemic

MHRA Good Practice (GxP) inspections during the COVID19 outbreak

Posted by: , Posted on: - Categories: Compliance matters, Good clinical practice, Good distribution practice, Good laboratory practice, Good manufacturing practice, Good pharmacovigilance practice
Virus particle

The COVID19 pandemic presents an unprecedented challenge to healthcare, the pharmaceutical industry’s supply chain and personnel movement. MHRA understands the impact of its work on industry, NHS and patients.

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

Posted by: , Posted on: - Categories: Compliance matters, Good clinical practice, Good distribution practice, Good laboratory practice, Good manufacturing practice, Good pharmacovigilance practice
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.

Too much pressure: a behavioural approach to Data Integrity (Part 1)

Posted by: , Posted on: - Categories: Compliance matters, Good clinical practice, Good distribution practice, Good laboratory practice, Good manufacturing practice, Good pharmacovigilance practice
Burst water pipe, leaking water

Global regulatory collaboration relating to data integrity remains a priority for MHRA and its international partners.

MHRA data integrity guidance: 18 months on

Posted by: , Posted on: - Categories: Compliance matters, Good clinical practice, Good distribution practice, Good laboratory practice, Good manufacturing practice, Good pharmacovigilance practice
MHRA has produced draft GxP data integrity guidance for industry and we welcome your comments”

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 …

Good Manufacturing Practice (GMP) data integrity: a new look at an old topic, part 3

Posted by: , Posted on: - Categories: Compliance matters, Good manufacturing practice
Vials in a laboratory

Data integrity is fundamental in a pharmaceutical quality system which ensures that medicines are of the required quality. A robust data governance approach will ensure that data is complete, consistent and accurate, irrespective of the format in which data is …

Good Manufacturing Practice (GMP) data integrity: a new look at an old topic, part 2

Posted by: , Posted on: - Categories: Compliance matters, Good manufacturing practice
Data charts on a screen

Data integrity is fundamental in a pharmaceutical quality system which ensures that medicines are of the required quality. A robust data governance approach will ensure that data is complete, consistent and accurate, irrespective of the format in which data is …

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This blog shares the work of the Medicines and Healthcare products Regulatory Agency (MHRA) Inspectorate, by inspectors and those the Inspectorate works with.

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