Sharing experience from recent events to help you safeguard the legitimate supply chain and avoid risks to public health
Expert GMDP Inspector
Medicines and Healthcare products Regulatory Agency (MHRA)
Tracy has been with the MHRA GMP Inspectorate since 2011 and prior to joining the MHRA worked in the pharmaceutical industry for over 22 years. She worked across all dosage forms within Quality roles. She is eligible to act as a Qualified Person under 2001/83 and did so for 6 and a half years within a sterile manufacturing capacity before joining the agency.
The definition of a falsified medicine and how to check that your systems comply
Implementation of the FMD safety features in the UK
The MHRA’s GXP data integrity guide has been published today.
Potential patient safety issues, serious breaches of GMP or suspected criminal activity frequently trigger short notice or unannounced inspections
An update on the use of short notice and unannounced GMP inspections
Related content and links
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
Comments and moderation
- 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