Members should conduct a documented review of their existing data integrity processes against the new OECD document to ensure that they fully comply and any required changes or additions are implemented.
I am a Senior GCP and GLP Inspector working across both the GCP and Laboratories groups within the Inspectorate. I have been with the MHRA since 2006 having previously worked within the NHS in hospital pharmacy.
On Tuesday 7 May 2019 representatives from trade organisations, professional bodies, non-commercial organisations and other regulators and government functions involved in the analysis of clinical trial laboratory samples were invited to attend the inaugural GCP Laboratories Stakeholder Engagement Meeting (StEM) …
We often receive questions about GCP training for laboratory staff, which suggests that this is a topic that causes quite a few laboratories issues!
Earlier this year I represented the MHRA at the 10th Workshop on Recent Issues in Bioanalysis (WRIB).
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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.