{
“@context”: “https://schema.org”,
“@type”: “Article”,
“mainEntityOfPage”: {
“@type”: “WebPage”,
“@id”: “https://www.clinicalstudies.in/sop-for-traceability-of-cell-tissue-based-products”
},
“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.”,
“author”: {
“@type”: “Organization”,
“name”: “ClinicalStudies.in”
},
“publisher”: {
“@type”: “Organization”,
“name”: “ClinicalStudies.in”,
“logo”: {
“@type”: “ImageObject”,
“url”: “https://www.clinicalstudies.in/logo.png”
}
},
“datePublished”: “2025-08-26”,
“dateModified”: “2025-08-26”
}

Standard Operating Procedure for Traceability of Cell/Tissue-Based Products

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). Traceability ensures donor-to-patient linkage, product integrity, subject safety, and regulatory compliance throughout collection, processing, distribution, administration, and long-term follow-up.

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

1. Donor-Recipient Linkage Log (Annexure-1)
2. Chain of Identity Log (Annexure-2)
3. Chain of Custody Log (Annexure-3)
4. Label Verification Log (Annexure-4)
5. Lot-to-Subject Mapping Log (Annexure-5)
6. 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

Annexures

Annexure-1: Donor-Recipient Linkage Log

Annexure-2: Chain of Identity Log

Annexure-3: Chain of Custody Log

Annexure-4: Label Verification Log

Annexure-5: Lot-to-Subject Mapping Log

Annexure-6: Follow-Up Traceability Log

Revision History

For more SOPs visit: Pharma SOP