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“headline”: “SOP for QP Certification Interface (GCP-GMP Handoff Expectations)”,
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Standard Operating Procedure for QP Certification Interface (GCP-GMP Handoff Expectations)

Purpose

The purpose of this SOP is to outline the Qualified Person (QP) certification process and define expectations for the interface between Good Clinical Practice (GCP) and Good Manufacturing Practice (GMP) during clinical trial product release. This ensures Investigational Medicinal Product (IMP) batches are certified, documented, and released in compliance with EU GMP Annex 13, EMA guidelines, and EU CTR 536/2014 requirements.

Scope

This SOP applies to sponsors, QPs, manufacturing sites, CROs, and QA staff responsible for manufacturing, packaging, and releasing IMPs for EU clinical trials. It covers certification activities, documentation review, IMP release, and archiving of certification records.

Responsibilities

• Qualified Person (QP): Certifies IMP batches before release to trial sites and ensures compliance with GMP Annex 13.
• Sponsor: Provides QP with necessary GCP trial documentation (protocol, approvals, investigator details).
• Manufacturer: Ensures IMP is manufactured and packaged according to GMP standards.
• CRO: Coordinates between sponsor, QP, and sites for product release and distribution.
• QA: Audits QP certification process and maintains inspection readiness.

Accountability

The Qualified Person (QP) is accountable for certifying IMP batches prior to release. The Sponsor is accountable for ensuring complete documentation and regulatory compliance for GCP-GMP handoff.

Procedure

1. Documentation Preparation
1.1 Sponsor provides QP with the Investigational Medicinal Product Dossier (IMPD), batch records, certificates of analysis (CoA), and clinical trial authorization.
1.2 Record in QP Documentation Log (Annexure-1).

2. Batch Certification
2.1 QP reviews batch manufacturing records for compliance with GMP.
2.2 Certify batch in QP Certification Log (Annexure-2).
2.3 Ensure certification statement is archived in TMF.

3. GCP-GMP Handoff
3.1 Sponsor ensures QP certification is documented before IMP shipment to sites.
3.2 QP communicates certification status to sponsor and CRO.
3.3 Record in Handoff Log (Annexure-3).

4. IMP Release
4.1 Distribute certified IMP to clinical sites only after QP release.
4.2 Maintain traceability in IMP Release Log (Annexure-4).

5. Non-Compliance Handling
5.1 If QP identifies GMP deviations, batch must not be released.
5.2 CAPA plan developed and recorded in Deviation Log (Annexure-5).

6. Archiving
6.1 Archive all certification documents in TMF for minimum 25 years.
6.2 Maintain archive record in Certification Archiving Log (Annexure-6).

Abbreviations

• SOP: Standard Operating Procedure
• QP: Qualified Person
• IMP: Investigational Medicinal Product
• GCP: Good Clinical Practice
• GMP: Good Manufacturing Practice
• EMA: European Medicines Agency
• CTR: Clinical Trials Regulation
• CRO: Contract Research Organization
• QA: Quality Assurance
• TMF: Trial Master File

Documents

1. QP Documentation Log (Annexure-1)
2. QP Certification Log (Annexure-2)
3. Handoff Log (Annexure-3)
4. IMP Release Log (Annexure-4)
5. Deviation Log (Annexure-5)
6. Certification Archiving Log (Annexure-6)

References

• EU GMP Annex 13 – IMPs
• EU Clinical Trials Regulation (536/2014)
• European Medicines Agency (EMA)
• ICH GCP Guidelines

Version: 1.0

Approval Section

Annexures

Annexure-1: QP Documentation Log

Annexure-2: QP Certification Log

Annexure-3: Handoff Log

Annexure-4: IMP Release Log

Annexure-5: Deviation Log

Annexure-6: Certification Archiving Log

Revision History

For more SOPs visit: Pharma SOP