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“headline”: “SOP for GMP-Compliant Handling of Gene/Cell Products at Sites”,
“description”: “This SOP defines procedures for GMP-compliant handling of gene and cell therapy products at clinical sites, ensuring compliance with FDA, EMA, CDSCO, WHO, and ICH GCP/GMP requirements. It covers receipt, storage, preparation, administration, and documentation of ATMPs.”,
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Published on 25/12/2025
Standard Operating Procedure for GMP-Compliant Handling of Gene/Cell Products at Sites
| SOP No. | CR/OPS/112/2025 |
| Supersedes | NA |
| Page No. | 1 of 55 |
| Issue Date | 26/08/2025 |
| Effective Date | 01/09/2025 |
| Review Date | 01/09/2026 |
Purpose
The purpose of this SOP is to establish GMP-compliant procedures for handling gene and cell therapy products at
Scope
This SOP applies to investigators, pharmacists, laboratory staff, nurses, CROs, and sponsors involved in the handling of Advanced Therapy Medicinal Products (ATMPs) at clinical trial sites. It covers receipt, storage, thawing, reconstitution, preparation, administration, environmental controls, and documentation.
Responsibilities
- Sponsor: Provides handling instructions and ensures training of site staff.
- Investigator: Ensures site-level compliance with GMP handling requirements.
- Pharmacist/Authorized Site Staff: Manage receipt, storage, preparation, and accountability of ATMPs.
- Nurses: Administer ATMPs as per protocol and handling instructions.
- QA: Audits compliance with GMP and GCP requirements.
Accountability
The Principal Investigator is accountable for site-level GMP-compliant handling of gene and cell therapy products. The Sponsor’s ATMP Quality Head is accountable for overall oversight and regulatory compliance.
Procedure
1. Product Receipt
1.1 Verify product identity, batch/lot number, and condition upon arrival.
1.2 Record details in ATMP Receipt Log (Annexure-1).
1.3 Report discrepancies or damages immediately to sponsor and QA.
2. Storage
2.1 Store ATMPs in secure, access-controlled, validated storage (cryogenic/freezer).
2.2 Maintain continuous temperature monitoring with alarms.
2.3 Document in ATMP Storage Log (Annexure-2).
3. Preparation
3.1 Prepare products in a GMP-compliant cleanroom or aseptic environment.
3.2 Follow manufacturer’s instructions for thawing, reconstitution, or dilution.
3.3 Record all steps in ATMP Preparation Log (Annexure-3).
4. Administration
4.1 Verify subject ID against chain of identity records.
4.2 Administer under medical supervision as per protocol.
4.3 Document in ATMP Administration Log (Annexure-4).
5. Accountability
5.1 Reconcile doses received, prepared, administered, returned, or destroyed.
5.2 Maintain ATMP Accountability Log (Annexure-5).
6. Environmental Monitoring
6.1 Monitor cleanroom conditions (temperature, humidity, particle counts).
6.2 Document in Environmental Monitoring Log (Annexure-6).
7. Deviations and CAPA
7.1 Record handling deviations in Deviation Log (Annexure-7).
7.2 Implement CAPA for deviations impacting quality or compliance.
8. Archiving
8.1 Archive all ATMP handling logs in TMF/ISF.
8.2 Retain per regulatory requirements (25 years for ATMPs in EU).
Abbreviations
- SOP: Standard Operating Procedure
- ATMP: Advanced Therapy Medicinal Products
- GMP: Good Manufacturing Practice
- GCP: Good Clinical Practice
- QA: Quality Assurance
- CRO: Contract Research Organization
- PI: Principal Investigator
- TMF: Trial Master File
- ISF: Investigator Site File
Documents
- ATMP Receipt Log (Annexure-1)
- ATMP Storage Log (Annexure-2)
- ATMP Preparation Log (Annexure-3)
- ATMP Administration Log (Annexure-4)
- ATMP Accountability Log (Annexure-5)
- Environmental Monitoring Log (Annexure-6)
- Deviation Log (Annexure-7)
References
- FDA – GMP for Cellular & Gene Therapy Products
- EMA – ATMP GMP Guidelines
- CDSCO – ATMP Handling Rules
- ICH GCP – GMP Interface for ATMPs
- WHO – Advanced Therapies GMP Standards
Version: 1.0
Approval Section
| Prepared By | Ravi Kumar, Site Pharmacist |
| Checked By | Sunita Reddy, QA Officer |
| Approved By | Dr. Anil Sharma, Head Clinical Operations |
Annexures
Annexure-1: ATMP Receipt Log
| Date | Product ID | Batch/Lot | Received By | Condition |
|---|---|---|---|---|
| 01/09/2025 | ATMP-101 | LOT-2025-01 | Pharmacist | Acceptable |
Annexure-2: ATMP Storage Log
| Date | Product ID | Storage Temp | Checked By | Status |
|---|---|---|---|---|
| 02/09/2025 | ATMP-101 | -150°C | Site Technician | Stable |
Annexure-3: ATMP Preparation Log
| Date | Product ID | Preparation Step | Performed By | Status |
|---|---|---|---|---|
| 03/09/2025 | ATMP-101 | Thawed and Reconstituted | Technician | Completed |
Annexure-4: ATMP Administration Log
| Date | Subject ID | Product ID | Administered By | Remarks |
|---|---|---|---|---|
| 04/09/2025 | S101 | ATMP-101 | Study Nurse | No issues |
Annexure-5: ATMP Accountability Log
| Date | Product ID | Doses Received | Doses Administered | Doses Remaining |
|---|---|---|---|---|
| 05/09/2025 | ATMP-101 | 5 | 2 | 3 |
Annexure-6: Environmental Monitoring Log
| Date | Parameter | Value | Checked By | Status |
|---|---|---|---|---|
| 06/09/2025 | Temperature | 22°C | Lab Assistant | Acceptable |
Annexure-7: Deviation Log
| Date | Deviation | Impact | Corrective Action | Approved By |
|---|---|---|---|---|
| 07/09/2025 | Temperature excursion | Moderate | Investigated & approved use | QA |
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