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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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Standard Operating Procedure for Vaccine IP Accountability and Wastage/Spillage

Purpose

The purpose of this SOP is to define standardized procedures for accountability and reconciliation of investigational vaccines (IP) used in clinical trials, as well as to describe actions for handling wastage and spillage. These procedures safeguard trial integrity, ensure accurate dosing records, and maintain regulatory compliance.

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

1. Vaccine Accountability Log (Annexure-1)
2. Wastage Log (Annexure-2)
3. Spillage Log (Annexure-3)
4. 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

Annexures

Annexure-1: Vaccine Accountability Log

Annexure-2: Wastage Log

Annexure-3: Spillage Log

Annexure-4: Destruction Certificate

Revision History

For more SOPs visit: Pharma SOP