Standard Operating Procedure for Third-Party Vendor Qualification (Labs, Courier) in BA/BE Studies
| Department | BA-BE Studies |
|---|---|
| SOP No. | SOP/BA-BE/039/2025 |
| Supersedes | SOP/BA-BE/039/2022 |
| Page No. | Page 1 of 13 |
| Issue Date | 17/04/2025 |
| Effective Date | 20/04/2025 |
| Review Date | 17/04/2026 |
1. Purpose
To define the standardized process for evaluating, qualifying, and approving third-party vendors including bioanalytical labs, logistics providers, and courier services involved in Bioavailability/Bioequivalence (BA/BE) studies.
2. Scope
This SOP applies to all external vendors providing critical services in BA/BE studies sponsored or managed by the organization. This includes bioanalytical laboratories, central labs, sample transport couriers, and document logistics partners.
3. Responsibilities
- Quality Assurance (QA): Leads vendor audit and qualification process.
- Clinical Project Manager: Initiates vendor selection and coordinates documentation flow.
- Regulatory Affairs: Confirms licensing and accreditation status of vendor.
- Procurement: Ensures agreements, pricing, and contracts are in place post-qualification.
4. Accountability
The Head of Quality is accountable for ensuring that no unqualified or unapproved vendor is engaged in any critical trial-related activity that can impact subject safety or data integrity.
5. Procedure
5.1 Vendor Identification and Initiation
- Identify potential vendors based on study requirements and geographical feasibility.
- Send Annexure-1: Vendor Prequalification Questionnaire for initial screening.
5.2 Documentation Review
- Collect the following from the vendor:
- Company profile and GMP/GLP certification
- List of equipment and validation records
- Sample transportation SOPs and temperature monitoring procedures
- Quality policy and past audit reports (if applicable)
5.3 Site Audit and Technical Evaluation
- Conduct an on-site or remote audit using Annexure-2: Vendor Audit Checklist.
- Evaluate parameters including:
- Sample handling capacity and storage conditions
- Turnaround time and contingency plans
- Personnel training and documentation practices
5.4 Approval and Onboarding
- Document findings in Annexure-3: Vendor Qualification Summary.
- Obtain final approval from QA Head using Annexure-4: Vendor Approval Form.
- Enter qualified vendor into Annexure-5: Approved Vendor Master List.
5.5 Periodic Requalification
- Vendors shall be re-evaluated every 2 years or after significant non-compliance events.
- Conduct spot audits if required and update qualification status accordingly.
6. Abbreviations
- BA: Bioavailability
- BE: Bioequivalence
- GLP: Good Laboratory Practice
- QA: Quality Assurance
- SOP: Standard Operating Procedure
7. Documents
- Vendor Prequalification Questionnaire – Annexure-1
- Vendor Audit Checklist – Annexure-2
- Vendor Qualification Summary – Annexure-3
- Vendor Approval Form – Annexure-4
- Approved Vendor Master List – Annexure-5
8. References
- ICH E6(R2) – Good Clinical Practice
- OECD Principles of GLP
- WHO Guidelines for the Preparation of BA/BE Protocols
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Vendor Prequalification Questionnaire
| Item | Response |
|---|---|
| GLP Certified? | Yes – NABL Accreditation Valid Till 2026 |
| Cold Chain Experience? | Yes, 2–8°C with data loggers |
Annexure-2: Vendor Audit Checklist
| Audit Area | Criteria | Compliant (Y/N) | Remarks |
|---|---|---|---|
| Sample Handling | Chain of custody documented | Y | Well maintained logs |
Annexure-3: Vendor Qualification Summary
| Vendor Name | Service | Audit Date | Qualified By | Status |
|---|---|---|---|---|
| Biotrack Labs Pvt. Ltd. | Bioanalysis | 12/04/2025 | Sunita Reddy | Qualified |
Annexure-4: Vendor Approval Form
| Vendor | Approved By | Date | Signature |
|---|---|---|---|
| TrackFast Couriers | Dr. Arvind Shah | 17/04/2025 |
Annexure-5: Approved Vendor Master List
| Vendor Name | Service Type | Valid From | Valid To | Status |
|---|---|---|---|---|
| ColdXpress Logistics | Sample Courier | 01/01/2024 | 31/12/2025 | Active |
Revision History:
| Revision Date | Revision No. | Details | Reason | Approved By |
|---|---|---|---|---|
| 10/01/2022 | 1.0 | Initial SOP | New vendor qualification process | QA Head |
| 17/04/2025 | 2.0 | Added courier evaluation, updated annexures | Audit and regulatory alignment | QA Head |