Why it's a good idea for the UK to be part of the OECD MAD framework
The issue faced when dealing with out of specification (OOS) results is as much a challenge now as it ever was. This post provides some guidance on how to handle OOS results.
I am pleased to share the news that the UK Good Laboratory Practice Monitoring Authority's (UK GLPMA) guidance on the implementation and maintenance of a risk-based GLP quality assurance (QA) programme has been published. The GLPMA have for some time recognised there …
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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.
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- Building resilience into clinical trial design and conduct during the pandemic
- 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