Module 3 2019

QP Certification and Batch Release

For a clinical trial in the EEA an IMP batch must be certified by an EEA Qualified Person before release for supply We Certify that the batch - Meets EU GMP Requirements

- Is in line with the Product Specification File - Is in line with the Clinical Trial Application

Also applies to batches which are manufactured in the EEA for supply outside the EEA

The Organisation for Professionals in Regulatory Affairs