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“headline”: “SOP for Traceability of Cell/Tissue-Based Products”,
“description”: “This SOP establishes standardized procedures for traceability of cell and tissue-based products in ATMP clinical trials. It ensures compliance with FDA, EMA, CDSCO, WHO, and ICH GCP/GMP requirements, covering donor-to-recipient linkage, custody, product labeling, and record retention.”,
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Published on 23/12/2025
Standard Operating Procedure for Traceability of Cell/Tissue-Based Products
| SOP No. | CR/OPS/114/2025 |
| Supersedes | NA |
| Page No. | 1 of 60 |
| Issue Date | 26/08/2025 |
| Effective Date | 01/09/2025 |
| Review Date | 01/09/2026 |
Purpose
The purpose of this SOP is to define standardized procedures for traceability of cell and tissue-based products used in clinical trials of Advanced Therapy Medicinal Products (ATMPs).
Scope
This SOP applies to sponsors, investigators, CROs, GMP facilities, laboratories, couriers, and site staff engaged in cell and tissue-based ATMP clinical trials. It covers subject-product linkage, chain of identity, chain of custody, labeling, lot-to-subject mapping, and archival of traceability records.
Responsibilities
- Sponsor: Ensures global traceability oversight and regulatory compliance.
- Investigator: Maintains subject-level traceability records and ensures verification before administration.
- GMP Facility: Maintains donor-to-product and product-to-recipient traceability logs.
- CRO: Verifies compliance with traceability SOPs across sites and vendors.
- Courier: Maintains custody logs for transported products.
- QA: Reviews traceability records and ensures inspection readiness.
Accountability
The Sponsor’s ATMP Traceability Lead is accountable for ensuring complete traceability records across the supply and clinical chain. Investigators are accountable for verification prior to administration.
Procedure
1. Donor/Subject Identification
1.1 Assign unique donor identifiers at collection.
1.2 Assign recipient/subject identifiers and link them to donor IDs where applicable.
1.3 Document in Donor-Recipient Linkage Log (Annexure-1).
2. Chain of Identity (CoI)
2.1 Verify donor and recipient identifiers at all steps.
2.2 Maintain subject-product linkage documentation.
2.3 Record in Chain of Identity Log (Annexure-2).
3. Chain of Custody (CoC)
3.1 Document custody transfers from collection to administration.
3.2 Require signatures from transferring and receiving parties.
3.3 Record in Chain of Custody Log (Annexure-3).
4. Product Labeling
4.1 Labels must contain donor ID, recipient ID, batch/lot number, storage conditions, and cautionary statements.
4.2 Verify label legibility and accuracy before use.
4.3 Record in Label Verification Log (Annexure-4).
5. Lot-to-Subject Mapping
5.1 Map each product batch or lot to corresponding subject IDs.
5.2 Record in Lot-to-Subject Mapping Log (Annexure-5).
6. Traceability During Follow-Up
6.1 Track product-related adverse events, defects, or recalls.
6.2 Document in Follow-Up Traceability Log (Annexure-6).
7. Archiving
7.1 Archive all traceability records in TMF and ISF.
7.2 Retain for minimum of 25 years or as required by regional laws.
Abbreviations
- SOP: Standard Operating Procedure
- ATMP: Advanced Therapy Medicinal Products
- CoI: Chain of Identity
- CoC: Chain of Custody
- 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
- Donor-Recipient Linkage Log (Annexure-1)
- Chain of Identity Log (Annexure-2)
- Chain of Custody Log (Annexure-3)
- Label Verification Log (Annexure-4)
- Lot-to-Subject Mapping Log (Annexure-5)
- Follow-Up Traceability Log (Annexure-6)
References
- FDA – Cell and Gene Therapy Traceability
- EMA – ATMP Traceability Guidance
- CDSCO – Traceability of Tissue and Cell-Based Products
- ICH GCP – Traceability and Record Keeping
- WHO – Traceability of Biological Products
Version: 1.0
Approval Section
| Prepared By | Ravi Kumar, ATMP Specialist |
| Checked By | Sunita Reddy, QA Officer |
| Approved By | Dr. Anil Sharma, Head Clinical Operations |
Annexures
Annexure-1: Donor-Recipient Linkage Log
| Date | Donor ID | Recipient ID | Linked By | Status |
|---|---|---|---|---|
| 01/09/2025 | D-101 | S101 | Coordinator | Verified |
Annexure-2: Chain of Identity Log
| Date | Product ID | Subject ID | Verified By | Status |
|---|---|---|---|---|
| 02/09/2025 | P-2025-01 | S101 | Investigator | Confirmed |
Annexure-3: Chain of Custody Log
| Date | Product ID | Transferred From | Transferred To | Signature |
|---|---|---|---|---|
| 03/09/2025 | P-2025-01 | Collection Site | Courier | Signed |
Annexure-4: Label Verification Log
| Date | Product ID | Label Text | Checked By | Status |
|---|---|---|---|---|
| 04/09/2025 | P-2025-01 | Donor: D-101 / Recipient: S101 | QA Officer | Compliant |
Annexure-5: Lot-to-Subject Mapping Log
| Date | Batch/Lot | Subject ID | Mapped By | Status |
|---|---|---|---|---|
| 05/09/2025 | LOT-2025-01 | S101 | Data Manager | Mapped |
Annexure-6: Follow-Up Traceability Log
| Date | Subject ID | Event | Reported By | Status |
|---|---|---|---|---|
| 10/09/2025 | S101 | Product-related AE: Graft Reaction | Investigator | Reported |
Revision History
| Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By |
|---|---|---|---|---|
| 26/08/2025 | 00 | Initial version | New SOP creation | Head Clinical Operations |
For more SOPs visit: Pharma SOP