Module 3 Presentations

07/05/2024

• For a clinical trial in the EEA/UK an IMP batch must be certified by an EEA/UK Qualified Person before release for supply • We Certify that the batch • Meets cGMP Requirements • Is in line with the Clinical Trial Application • Is in line with the Product Specification File • Imported IMP has been manufactured to standards equivalent to EU GMP • A QP must personally ensure that: QP Certification and Batch Release (Annex 13 & 16)

• Certification is permitted under the terms of the MIA.

• Any additional duties and requirements of national legislation are complied with.

• Certification is recorded in a register or equivalent document.

The Organisation for Professionals in Regulatory Affairs

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QP delegated responsibility & Annex 16 ………

Batch Records

Supply Chain

Audit Reports

Agreements

Validation

QC

Stability

TSE

Batch Records

Changes

Deviations

OOS

Self Inspection

Complaints

Distribution

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