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“headline”: “SOP for Vaccine Trial Conduct Aligned with WHO PQ/Prequalification Guidance”,
“description”: “This SOP describes procedures for conducting vaccine trials in alignment with WHO Prequalification (PQ) guidance. It ensures compliance with WHO standards, ethical practices, and readiness for PQ dossier submission supporting global vaccine procurement.”,
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“datePublished”: “2025-08-26”,
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Published on 26/12/2025
Standard Operating Procedure for Vaccine Trial Conduct Aligned with WHO PQ/Prequalification Guidance
| SOP No. | CR/OPS/152/2025 |
| Supersedes | NA |
| Page No. | X of Y |
| 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 conducting vaccine clinical trials in alignment with World
Scope
This SOP applies to sponsors, CROs, investigators, QA, and regulatory affairs teams engaged in vaccine trials intended for WHO PQ submission. It covers trial design considerations, operational procedures, data integrity requirements, and dossier preparation.
Responsibilities
- Sponsor: Ensures trial design and execution align with WHO PQ guidance and GCP.
- CRO: Oversees operational compliance with PQ trial requirements.
- Investigator: Conducts vaccine trial activities according to protocol, GCP, and PQ standards.
- QA: Audits vaccine trial processes and ensures PQ-readiness of trial data.
- Regulatory Affairs: Coordinates submissions with WHO PQ program.
Accountability
The Sponsor’s Clinical and Regulatory Heads are accountable for ensuring that vaccine trials are PQ-compliant, and trial data is suitable for PQ dossier submission.
Procedure
1. Trial Design and Protocol Development
1.1 Incorporate WHO PQ requirements into vaccine trial protocols.
1.2 Ensure inclusion of appropriate endpoints (safety, immunogenicity, efficacy).
1.3 Document in Protocol Compliance Log (Annexure-1).
2. Site Preparation and Training
2.1 Select PQ-ready trial sites with vaccine cold chain capacity.
2.2 Conduct training for investigators and staff on PQ standards.
2.3 Document in Training Log (Annexure-2).
3. Vaccine Handling and Cold Chain
3.1 Maintain WHO-recommended cold chain conditions (2–8°C unless specified).
3.2 Record in Vaccine Cold Chain Log (Annexure-3).
4. Data Collection and Integrity
4.1 Collect safety, efficacy, and immunogenicity data per PQ requirements.
4.2 Ensure ALCOA+ principles in data capture.
4.3 Document in Data Integrity Log (Annexure-4).
5. SAE and SUSAR Reporting
5.1 Report safety events per WHO PQ requirements.
5.2 Document in Safety Reporting Log (Annexure-5).
6. PQ Dossier Preparation
6.1 Compile PQ dossier sections covering quality, safety, and efficacy.
6.2 Archive dossier documents in TMF.
6.3 Record in PQ Dossier Preparation Log (Annexure-6).
Abbreviations
- SOP: Standard Operating Procedure
- PQ: Prequalification
- WHO: World Health Organization
- CRO: Contract Research Organization
- QA: Quality Assurance
- SAE: Serious Adverse Event
- SUSAR: Suspected Unexpected Serious Adverse Reaction
- TMF: Trial Master File
- GCP: Good Clinical Practice
Documents
- Protocol Compliance Log (Annexure-1)
- Training Log (Annexure-2)
- Vaccine Cold Chain Log (Annexure-3)
- Data Integrity Log (Annexure-4)
- Safety Reporting Log (Annexure-5)
- PQ Dossier Preparation Log (Annexure-6)
References
Version: 1.0
Approval Section
| Prepared By | Ravi Kumar, Vaccine Trial Coordinator |
| Checked By | Sunita Reddy, QA Officer |
| Approved By | Dr. Anil Sharma, Head Clinical Operations |
Annexures
Annexure-1: Protocol Compliance Log
| Date | Protocol ID | Compliance Check | Checked By | Status |
|---|---|---|---|---|
| 01/09/2025 | VAC-2025-01 | Endpoints Verified | Reg Affairs | Compliant |
Annexure-2: Training Log
| Date | Site | Staff Trained | Trainer | Status |
|---|---|---|---|---|
| 02/09/2025 | Mumbai Site | 12 | QA Officer | Completed |
Annexure-3: Vaccine Cold Chain Log
| Date | Vaccine Batch | Temperature | Checked By | Status |
|---|---|---|---|---|
| 03/09/2025 | VAC-LOT-001 | +4°C | Site Pharmacist | Maintained |
Annexure-4: Data Integrity Log
| Date | Data Type | Verification Method | Verified By | Status |
|---|---|---|---|---|
| 05/09/2025 | Immunogenicity | Double Data Entry | Data Manager | Validated |
Annexure-5: Safety Reporting Log
| Date | Event | Reported To | Reported By | Status |
|---|---|---|---|---|
| 06/09/2025 | Local Reaction | WHO PQ Safety | Investigator | Submitted |
Annexure-6: PQ Dossier Preparation Log
| Date | Dossier Section | Prepared By | Status |
|---|---|---|---|
| 10/09/2025 | Safety Module | Regulatory Affairs | Completed |
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