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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

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“headline”: “SOP for ATMP Trial Design and Submissions (Advanced Therapies)”,
“description”: “This SOP provides standardized guidance for designing clinical trials and preparing regulatory submissions for Advanced Therapy Medicinal Products (ATMPs). It ensures compliance with FDA, EMA, CDSCO, WHO, and ICH GCP requirements, covering protocol design, dossier preparation, ethics submissions, and global trial oversight.”,
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Standard Operating Procedure for ATMP Trial Design and Submissions (Advanced Therapies)

Purpose

The purpose of this SOP is to establish standardized procedures for the design and regulatory submissions of clinical trials involving Advanced Therapy Medicinal Products (ATMPs), including gene therapies, cell therapies, and tissue-engineered products. This ensures patient safety, data integrity, and regulatory compliance across regions.

Scope

This SOP applies to sponsors, investigators, CROs, regulatory affairs specialists, and QA teams involved in ATMP clinical trials. It covers trial design, protocol development, ethics and regulatory submissions, dossier preparation, global submission requirements, and oversight of ATMP-specific risks and long-term follow-up.

Responsibilities

• Sponsor: Oversees ATMP trial design, dossier preparation, and regulatory submissions.
• Regulatory Affairs: Prepares and manages submissions to FDA, EMA, CDSCO, and other authorities.
• Investigator: Ensures proper design and execution of ATMP trials at site level.
• CRO: Supports monitoring and documentation for ATMP compliance.
• QA: Verifies adherence to ATMP-specific GCP and GMP requirements.

Accountability

The Sponsor’s Head of Regulatory Affairs is accountable for ensuring ATMP trial design and submissions meet global regulatory requirements. Investigators are accountable for site-level trial execution.

Procedure

1. Trial Design
1.1 Define study objectives, endpoints, and patient population.
1.2 Conduct risk-benefit assessment specific to ATMPs.
1.3 Design inclusion/exclusion criteria addressing ATMP risks.
1.4 Document in ATMP Trial Design Log (Annexure-1).

2. Protocol Development
2.1 Develop protocol including manufacturing, administration, and follow-up requirements.
2.2 Include long-term follow-up design for gene and cell therapies.
2.3 Record in Protocol Development Log (Annexure-2).

3. Ethics and Regulatory Submissions
3.1 Submit trial documents to EC/IRB for review and approval.
3.2 Submit to regulatory authorities (FDA IND, EMA CTA, CDSCO CTN/CTA).
3.3 Maintain Regulatory Submission Log (Annexure-3).

4. Dossier Preparation
4.1 Prepare dossier with preclinical, manufacturing, and clinical data.
4.2 Ensure compliance with region-specific ATMP requirements.
4.3 Record in Dossier Preparation Log (Annexure-4).

5. Risk Management
5.1 Develop Risk Management Plan addressing ATMP-specific risks.
5.2 Maintain in Risk Management Log (Annexure-5).

6. Global Oversight
6.1 Coordinate submissions across multiple regions.
6.2 Track approvals and responses in Global Oversight Log (Annexure-6).

7. Archiving
7.1 Archive trial design, submission, and approval records in TMF.
7.2 Retain records as per regulatory timelines.

Abbreviations

• SOP: Standard Operating Procedure
• ATMP: Advanced Therapy Medicinal Products
• QA: Quality Assurance
• CRO: Contract Research Organization
• TMF: Trial Master File
• FDA: Food and Drug Administration
• EMA: European Medicines Agency
• CDSCO: Central Drugs Standard Control Organization
• IRB/EC: Institutional Review Board/Ethics Committee
• CTA: Clinical Trial Application
• CTN: Clinical Trial Notification
• IND: Investigational New Drug Application

Documents

1. ATMP Trial Design Log (Annexure-1)
2. Protocol Development Log (Annexure-2)
3. Regulatory Submission Log (Annexure-3)
4. Dossier Preparation Log (Annexure-4)
5. Risk Management Log (Annexure-5)
6. Global Oversight Log (Annexure-6)

References

• FDA – Cellular & Gene Therapy Guidance
• EMA – ATMP Guidelines
• CDSCO – ATMP Clinical Trial Rules
• ICH GCP – ATMP Trial Guidance
• WHO – Advanced Therapy Medicinal Products Recommendations

Version: 1.0

Approval Section

Annexures

Annexure-1: ATMP Trial Design Log

Annexure-2: Protocol Development Log

Annexure-3: Regulatory Submission Log

Annexure-4: Dossier Preparation Log

Annexure-5: Risk Management Log

Annexure-6: Global Oversight Log

Revision History

For more SOPs visit: Pharma SOP