GCP Inspection Findings published
![GMP meets Development](files/eca/userImages/training.img/Z-ECA-GMP-meets-Development.jpg)
Recommendation
5-7 November 2024
Hamburg, Germany
GMP and FDA Compliance in Pharmaceutical Development and IMP Manufacturing
The U.K. Medicines and Healthcare Products Regulatory Agency MHRA has compiled a GCP Inspections Metrics Report. This report summarises 125 GCP Inspections which were undertaken by the MHRA GCP Inspectorate from 1st April 2013 to 31st March 2014. Now, almost two years later, this interesting overview was published.
When looking at the data, the importance of a robust Quality Management System becomes obvious. Observations in this area are number one for CRO Inspections and number two for Non-Commercial Sponsors closely behind Clinical Trial Oversight. All findings are listed as major grading.
Related GMP News
23.07.2024Pilot Results on Regulatory-Led RWE Generation
23.07.2024ICH M12 Guideline on Drug Interaction Studies
20.06.2024Draft ICH M14 Guideline on Real-World Data for Safety Assessment
20.06.2024Glossary of Terms and Definitions for Innovative Clinical Trials
21.05.2024Real-World Evidence: FDA´s Considerations for Non-Interventional Studies
14.05.2024How to Handle and Reserve Samples from BA / BE Studies