The GXP environment is evolving as digital technologies are increasingly being applied to the development and manufacture of medicines.
Former Deputy Director of the Inspection, Enforcement and Standards Division and Head of the MHRA Inspectorate & Process Licencing which employs over 75 Inspectors covering GCP, GDP, GLP, GMP & GPvP and the Process Licencing team
Group Manager of MHRA Devices Safety and Surveillance Group & Devices Software and Apps Group.
Joined the MHRA in 2002 as a GMP Inspector having previously worked in the pharmaceutical industry for over 10 years.
From 8 to 10 April 2019, the Pharmaceutical Inspection Co-operation Scheme (PIC/S) Committee and PIC/S Executive Bureau meetings took place in Geneva, Switzerland.
An update on staff changes within the Inspectorate
The Process Licensing Office has today joined the Inspectorate to become the Inspectorate & Process Licensing Group.
From 16 to 18 April 2018 the PIC/S Committee and PIC/S Executive Bureau meetings took place in Geneva, Switzerland.
Whilst we progress our latest recruitment campaign for GMDP Inspectors, Ian Holloway reflects on 30 years of working for the Medicines Regulator.
Today marks the start of the operational phase of the EU-FDA mutual recognition agreement
The MHRA has seen an increasing number of inspections being conducted in both the UK and the rest of the EU by regulators from other countries.
From 11 to 15 September 2017 I attended the PIC/S Committee meeting, Executive Bureau meeting, and Annual Seminar hosted by the Taiwan Food and Drug Administration (TFDA)
A bite sized summary of our recent posting to the MHRA Inspectorate blog
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About the MHRA Inspectorate Blog
This blog shares the work of the Medicines and Healthcare products Regulatory Agency (MHRA) Inspectorate, by inspectors and those the Inspectorate works with.
MHRA Inspectorate & Process Licensing Organogram
Other MHRA Blogs
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- A fresh look at an old topic: Investigations in the GMDP environment
- Cross Contamination Control in Shared Facilities and Equipment. Reflection on common deficiencies and expectations as seen in recent PIC/S guidance.
- GCP Serious Breaches update
- MHRA planning for return to on-site Good Practice (GxP) inspections
- A Practical example of applying Quality Risk Management in GDP – Transportation Risks