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

David Churchward, 23 July 2020 - Compliance matters, Good clinical practice, Good distribution practice, Good laboratory practice, Good manufacturing practice, Good pharmacovigilance practice

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

David Churchward, 23 March 2020 - Compliance matters, Good clinical practice, Good distribution practice, Good laboratory practice, Good manufacturing practice, Good pharmacovigilance practice

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.

Quality Culture: Learning from History

David Churchward, 28 February 2019 - Compliance matters, Good manufacturing practice

In today’s computerised, high-tech pharmaceutical environment, it is worth reflecting on the Clothier report conclusions from 47 years ago.

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

David Churchward, 30 March 2017 - Compliance matters, Good clinical practice, Good distribution practice, Good laboratory practice, Good manufacturing practice, Good pharmacovigilance practice

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)

David Churchward, 10 March 2017 - Compliance matters, Good clinical practice, Good distribution practice, Good laboratory practice, Good manufacturing practice, Good pharmacovigilance practice

Global regulatory collaboration relating to data integrity remains a priority for MHRA and its international partners. In October 2016 I attended international data integrity workshops in China, hosted by CPAPE...

MHRA data integrity guidance: 18 months on

David Churchward, 21 July 2016 - Compliance matters, Good clinical practice, Good distribution practice, Good laboratory practice, Good manufacturing practice, Good pharmacovigilance practice

...data integrity in the context of GMP and GDP inspections. Our team has also been working with stakeholders in the international GLP and GCP networks to raise awareness of the...

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

David Churchward, 27 August 2015 - Compliance matters, Good manufacturing practice

...the analytical requirement without raising data integrity concerns relating to ‘testing into compliance’. A robust laboratory data governance approach will also include periodic reconciliation of analytical sample runs, to confirm...

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

David Churchward, 14 July 2015 - Compliance matters, Good manufacturing practice

...may also require periodic checks, such as equipment performance. Specifying exact time intervals (eg ‘every 60 minutes’) may result in an incentive for staff to ‘back date’ the time of...

Good Manufacturing Practice (GMP) data integrity: a new look at an old topic, part 1

David Churchward, 25 June 2015 - Compliance matters, Good manufacturing practice

Data integrity is fundamental in a pharmaceutical quality system which ensures that medicines are of the required quality.

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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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