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“headline”: “SOP for Local Lab Accreditation Verification and Documentation (India-Specific)”,
“description”: “This SOP defines standardized procedures for verifying and documenting local laboratory accreditations in Indian clinical trials. It ensures compliance with CDSCO/DCGI requirements, NABL certification checks, and archiving of accreditation records for regulatory inspections.”,
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Published on 23/12/2025
Standard Operating Procedure for Local Lab Accreditation Verification and Documentation (India-Specific)
| SOP No. | CR/OPS/148/2025 |
| 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 outline the procedure for verifying and documenting the accreditation of local laboratories used in Indian
Scope
This SOP applies to sponsors, CROs, investigators, QA, and site staff responsible for selecting, verifying, and using local laboratories for clinical trial sample analysis in India. It covers accreditation verification, documentation, and maintenance of records in TMF and ISF for regulatory inspections.
Responsibilities
- Sponsor: Ensures that all trial laboratories used are appropriately accredited and compliant with regulations.
- CRO: Conducts verification of lab accreditation and communicates findings to the sponsor.
- Investigator: Confirms that site laboratories hold valid accreditation.
- QA: Audits lab records to ensure accreditation and inspection readiness.
- Laboratory: Maintains valid accreditation and provides updated certificates.
Accountability
The Sponsor’s Regulatory Affairs and QA Heads are accountable for ensuring valid accreditation of laboratories used in Indian clinical trials and proper documentation of all certificates.
Procedure
1. Laboratory Selection and Verification
1.1 Obtain accreditation certificate (NABL or equivalent) from each laboratory.
1.2 Verify certificate validity on NABL website or issuing authority.
1.3 Record in Lab Accreditation Verification Log (Annexure-1).
2. Documentation
2.1 File accreditation certificates in TMF and ISF.
2.2 Maintain copies at sponsor and CRO levels.
2.3 Record in Accreditation Document Log (Annexure-2).
3. Renewal Tracking
3.1 Track certificate expiration dates.
3.2 Request updated accreditation certificates before expiry.
3.3 Record in Renewal Tracking Log (Annexure-3).
4. Non-Compliant Laboratories
4.1 Do not use non-accredited laboratories.
4.2 Document issues in Non-Compliance Log (Annexure-4).
5. Audit and Inspection
5.1 Maintain inspection-ready accreditation records.
5.2 Conduct periodic audits recorded in Lab Audit Log (Annexure-5).
Abbreviations
- SOP: Standard Operating Procedure
- EC: Ethics Committee
- DCGI: Drugs Controller General of India
- CDSCO: Central Drugs Standard Control Organization
- NABL: National Accreditation Board for Testing and Calibration Laboratories
- CRO: Contract Research Organization
- QA: Quality Assurance
- TMF: Trial Master File
- ISF: Investigator Site File
- NDCTR: New Drugs and Clinical Trials Rules
Documents
- Lab Accreditation Verification Log (Annexure-1)
- Accreditation Document Log (Annexure-2)
- Renewal Tracking Log (Annexure-3)
- Non-Compliance Log (Annexure-4)
- Lab Audit Log (Annexure-5)
References
- National Accreditation Board for Testing and Calibration Laboratories (NABL)
- CDSCO – Central Drugs Standard Control Organization
- New Drugs and Clinical Trials Rules, 2019
Version: 1.0
Approval Section
| Prepared By | Ravi Kumar, Clinical Research Associate |
| Checked By | Sunita Reddy, QA Officer |
| Approved By | Dr. Anil Sharma, Head Clinical Operations |
Annexures
Annexure-1: Lab Accreditation Verification Log
| Date | Lab Name | Accreditation No. | Verified By | Status |
|---|---|---|---|---|
| 01/09/2025 | XYZ Path Labs | NABL/2024/567 | CRO Monitor | Verified |
Annexure-2: Accreditation Document Log
| Date | Lab Name | Certificate Filed | Filed By | Status |
|---|---|---|---|---|
| 02/09/2025 | XYZ Path Labs | Yes | Reg Affairs | Archived |
Annexure-3: Renewal Tracking Log
| Date | Lab Name | Certificate Expiry | Status | Checked By |
|---|---|---|---|---|
| 05/09/2025 | XYZ Path Labs | 30/06/2026 | Valid | QA |
Annexure-4: Non-Compliance Log
| Date | Lab Name | Issue | Reported By | Status |
|---|---|---|---|---|
| 07/09/2025 | ABC Labs | Accreditation Expired | CRA | Escalated |
Annexure-5: Lab Audit Log
| Date | Audit Type | Performed By | Status |
|---|---|---|---|
| 10/09/2025 | Mock DCGI Inspection | QA | Compliant |
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