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Standard Operating Procedure for Local Lab Accreditation Verification and Documentation (India-Specific)

Purpose

The purpose of this SOP is to outline the procedure for verifying and documenting the accreditation of local laboratories used in Indian clinical trials. This ensures compliance with DCGI/CDSCO and New Drugs and Clinical Trials Rules (NDCTR 2019), while safeguarding data integrity, reliability, and subject safety. Accreditation primarily refers to NABL (National Accreditation Board for Testing and Calibration Laboratories) certification or equivalent.

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

1. Lab Accreditation Verification Log (Annexure-1)
2. Accreditation Document Log (Annexure-2)
3. Renewal Tracking Log (Annexure-3)
4. Non-Compliance Log (Annexure-4)
5. 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

Annexures

Annexure-1: Lab Accreditation Verification Log

Annexure-2: Accreditation Document Log

Annexure-3: Renewal Tracking Log

Annexure-4: Non-Compliance Log

Annexure-5: Lab Audit Log

Revision History

For more SOPs visit: Pharma SOP