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“headline”: “SOP for Vaccine IP Accountability and Wastage/Spillage”,
“description”: “This SOP establishes procedures for accountability, reconciliation, and handling of wastage and spillage of investigational vaccines (IP) during clinical trials. It ensures compliance with FDA, EMA, CDSCO, WHO, and ICH GCP requirements for vaccine storage, use, accountability, and destruction.”,
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Published on 23/12/2025
Standard Operating Procedure for Vaccine IP Accountability and Wastage/Spillage
| SOP No. | CR/OPS/116/2025 |
| Supersedes | NA |
| Page No. | 1 of 58 |
| 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 accountability and reconciliation of investigational vaccines (IP) used in clinical trials,
Scope
This SOP applies to sponsors, investigators, pharmacists, CROs, and site staff involved in vaccine clinical trials. It covers accountability records, wastage management, spillage handling, destruction, return processes, and documentation at all trial stages.
Responsibilities
- Sponsor: Ensures adequate systems for IP accountability and oversees reconciliation.
- Investigator: Maintains accurate accountability logs and ensures prompt reporting of wastage/spillage.
- Pharmacist/Site Staff: Document vaccine receipt, use, wastage, destruction, or return.
- CRO: Verifies accountability records and monitors wastage reports.
- QA: Reviews accountability logs and ensures compliance with GCP and GMP.
Accountability
The Investigator is accountable for IP accountability, wastage, and spillage records at the site. The Sponsor is accountable for overall oversight and reconciliation of vaccine IP across sites.
Procedure
1. Vaccine IP Receipt and Storage
1.1 Record all vaccine IP received in Vaccine Receipt Log.
1.2 Store in validated storage with continuous temperature monitoring.
1.3 Document in Vaccine Storage Log.
2. IP Accountability
2.1 Record doses received, dispensed, administered, returned, destroyed, or wasted.
2.2 Reconcile balances weekly and at study closeout.
2.3 Maintain Vaccine Accountability Log (Annexure-1).
3. Wastage Management
3.1 Document reasons for wastage (e.g., expired, broken vials, temperature excursion).
3.2 Record in Wastage Log (Annexure-2).
3.3 Notify Sponsor and QA.
4. Spillage Handling
4.1 Contain spill immediately using PPE and absorbent materials.
4.2 Dispose waste as per biosafety and hazardous waste protocols.
4.3 Document incident in Spillage Log (Annexure-3).
5. Destruction or Return
5.1 Destroy unusable vaccine IP as per biosafety regulations with QA oversight.
5.2 Obtain Destruction Certificate (Annexure-4).
5.3 Return unused IP if required by sponsor.
6. Reconciliation
6.1 Conduct reconciliation at site closeout and sponsor level.
6.2 Ensure accountability records match physical inventory.
7. Archiving
7.1 Archive accountability, wastage, and spillage records in TMF and ISF.
7.2 Retain per regulatory requirements.
Abbreviations
- SOP: Standard Operating Procedure
- IP: Investigational Product
- QA: Quality Assurance
- CRO: Contract Research Organization
- TMF: Trial Master File
- ISF: Investigator Site File
- GCP: Good Clinical Practice
- GMP: Good Manufacturing Practice
- PPE: Personal Protective Equipment
Documents
- Vaccine Accountability Log (Annexure-1)
- Wastage Log (Annexure-2)
- Spillage Log (Annexure-3)
- Destruction Certificate (Annexure-4)
References
- FDA – Vaccine Accountability Guidance
- EMA – Vaccine Accountability Guidelines
- CDSCO – Vaccine Accountability Rules
- ICH GCP – IP Accountability
- WHO – Vaccine Wastage and Spillage Handling
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: Vaccine Accountability Log
| Date | Vaccine ID | Doses Received | Doses Used | Doses Remaining | Checked By |
|---|---|---|---|---|---|
| 01/09/2025 | VAC-101 | 1000 | 500 | 500 | QA Officer |
Annexure-2: Wastage Log
| Date | Vaccine ID | Reason | Doses Wasted | Recorded By |
|---|---|---|---|---|
| 02/09/2025 | VAC-101 | Temperature Excursion | 20 | Pharmacist |
Annexure-3: Spillage Log
| Date | Vaccine ID | Spillage Incident | Action Taken | Recorded By |
|---|---|---|---|---|
| 03/09/2025 | VAC-101 | Broken Vial | Cleaned, Disposed | Study Nurse |
Annexure-4: Destruction Certificate
| Date | Vaccine ID | Doses Destroyed | Method | Approved By |
|---|---|---|---|---|
| 05/09/2025 | VAC-101 | 50 | Autoclave Disposal | QA Officer |
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