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“headline”: “SOP for Chain of Identity & Chain of Custody (Cell/Gene)”,
“description”: “This SOP establishes procedures for maintaining chain of identity and chain of custody in cell and gene therapy clinical trials. It ensures compliance with FDA, EMA, CDSCO, WHO, and ICH GCP/GMP requirements, covering traceability, custody, product handling, and regulatory oversight.”,
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Standard Operating Procedure for Chain of Identity & Chain of Custody (Cell/Gene)

Purpose

The purpose of this SOP is to define the processes required to maintain Chain of Identity (CoI) and Chain of Custody (CoC) for cell and gene therapy products used in clinical trials. These processes ensure traceability, product integrity, subject safety, and regulatory compliance from collection through administration and follow-up.

Scope

This SOP applies to sponsors, investigators, CROs, laboratories, GMP manufacturing facilities, couriers, and site staff involved in ATMP (Advanced Therapy Medicinal Product) clinical trials. It covers sample collection, labeling, custody transfers, product tracking, custody documentation, and archival of records.

Responsibilities

• Sponsor: Oversees CoI/CoC processes and ensures regulatory compliance.
• Investigator: Ensures subject-specific identity verification at site level.
• GMP Facility: Maintains manufacturing custody records and certificates of analysis.
• CRO: Monitors CoI/CoC compliance across sites and vendors.
• Courier: Maintains custody during product transportation.
• QA: Audits CoI/CoC logs for accuracy and completeness.

Accountability

The Sponsor’s ATMP Quality Lead is accountable for overall compliance with Chain of Identity and Chain of Custody procedures. The Investigator is accountable for subject-level verification prior to administration.

Procedure

1. Chain of Identity (CoI)
1.1 Assign unique subject-specific identifiers at time of collection.
1.2 Verify identifiers at each step: collection, processing, manufacturing, and administration.
1.3 Document in Chain of Identity Log (Annexure-1).

2. Chain of Custody (CoC)
2.1 Record all custody transfers from collection through manufacturing, shipment, storage, and administration.
2.2 Use controlled custody forms signed by transferring and receiving personnel.
2.3 Maintain records in Chain of Custody Log (Annexure-2).

3. Custody Transfer
3.1 At each transfer, verify subject identifier, product batch/lot number, and condition.
3.2 Document signatures, date, and time for both transferring and receiving parties.

4. Manufacturing and Quality Control
4.1 GMP facility verifies CoI before initiating processing.
4.2 Issue Certificate of Analysis linked to subject-specific identifiers.

5. Shipment and Storage
5.1 Use validated containers and cold-chain requirements.
5.2 Record shipment details in Custody Transfer Log (Annexure-3).

6. Administration at Site
6.1 Prior to administration, Investigator verifies subject identifier against CoI records.
6.2 Document in Site Administration Log (Annexure-4).

7. Archiving
7.1 Archive all CoI/CoC records in TMF and ISF.
7.2 Retain per global ATMP regulations (minimum 25 years in some regions).

Abbreviations

• SOP: Standard Operating Procedure
• CoI: Chain of Identity
• CoC: Chain of Custody
• ATMP: Advanced Therapy Medicinal Products
• QA: Quality Assurance
• CRO: Contract Research Organization
• GMP: Good Manufacturing Practice
• TMF: Trial Master File
• ISF: Investigator Site File
• FDA: Food and Drug Administration
• EMA: European Medicines Agency
• CDSCO: Central Drugs Standard Control Organization
• WHO: World Health Organization

Documents

1. Chain of Identity Log (Annexure-1)
2. Chain of Custody Log (Annexure-2)
3. Custody Transfer Log (Annexure-3)
4. Site Administration Log (Annexure-4)

References

• FDA – Cellular & Gene Therapy Oversight
• EMA – ATMP Guidelines
• CDSCO – Cell & Gene Therapy Regulations
• ICH GCP – ATMP Trials
• WHO – ATMP Chain of Custody Recommendations

Version: 1.0

Approval Section

Annexures

Annexure-1: Chain of Identity Log

Annexure-2: Chain of Custody Log

Annexure-3: Custody Transfer Log

Annexure-4: Site Administration Log

Revision History

For more SOPs visit: Pharma SOP