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Standard Operating Procedure for Laboratory Accreditation/Qualification Verification

Purpose

The purpose of this SOP is to ensure that laboratories performing clinical trial analyses are accredited, qualified, and compliant with global regulatory and quality standards. Verification of accreditation and qualification safeguards data integrity and subject safety while ensuring inspection readiness.

Scope

This SOP applies to sponsor organizations, CROs, QA personnel, and laboratory managers responsible for selecting, qualifying, and monitoring laboratories that conduct clinical trial analyses. It covers vendor audits, accreditation verification, ongoing compliance checks, and CAPA follow-up.

Responsibilities

• Sponsor: Ensures laboratories used in clinical trials are accredited and qualified.
• QA: Conducts audits, verifies certificates, and manages CAPA implementation.
• Laboratory Manager: Maintains accreditation status and provides documentation.
• CRO: Oversees vendor laboratories and ensures compliance on behalf of sponsor.
• Vendors: Provide valid accreditation certificates and allow audits.

Accountability

The Sponsor is accountable for laboratory qualification and oversight. QA is accountable for verifying accreditation status, conducting audits, and maintaining compliance documentation.

Procedure

1. Pre-Qualification
1.1 Identify laboratories with relevant scope and expertise.
1.2 Verify accreditation (e.g., ISO/IEC 17025, CAP, NABL, GLP).
1.3 Document accreditation details in Laboratory Qualification Log (Annexure-1).

2. Document Review
2.1 Request accreditation certificates and audit reports from laboratory.
2.2 Verify validity dates, scope of testing, and issuing authority.
2.3 Retain copies in Trial Master File (TMF).

3. Audit and Assessment
3.1 Conduct on-site or remote audit prior to laboratory engagement.
3.2 Evaluate compliance with GLP, GCP, and protocol-specific requirements.
3.3 Record findings in Laboratory Audit Report (Annexure-2).

4. Approval and Qualification
4.1 Sponsor QA approves laboratory based on audit outcome.
4.2 Issue Laboratory Qualification Certificate (Annexure-3).
4.3 Only qualified laboratories may perform trial-related analyses.

5. Ongoing Verification
5.1 Review laboratory accreditation status annually.
5.2 Monitor regulatory inspection reports and CAPA responses.
5.3 Maintain Accreditation Verification Log (Annexure-4).

6. Renewal and Requalification
6.1 Laboratories must provide updated certificates prior to expiry.
6.2 Conduct requalification audits every 3 years.

7. Non-Compliance
7.1 If accreditation lapses, immediately suspend laboratory testing.
7.2 Document issue in Non-Compliance Log (Annexure-5).
7.3 Implement CAPA before laboratory re-engagement.

Abbreviations

• SOP: Standard Operating Procedure
• QA: Quality Assurance
• CRO: Contract Research Organization
• TMF: Trial Master File
• CAPA: Corrective and Preventive Action
• ISO/IEC 17025: International Laboratory Accreditation Standard
• GLP: Good Laboratory Practice

Documents

1. Laboratory Qualification Log (Annexure-1)
2. Laboratory Audit Report (Annexure-2)
3. Laboratory Qualification Certificate (Annexure-3)
4. Accreditation Verification Log (Annexure-4)
5. Non-Compliance Log (Annexure-5)

References

• ICH GCP – Laboratory Standards
• FDA – Laboratory Accreditation Guidance
• EMA – Clinical Laboratory Qualification
• CDSCO – Laboratory Accreditation Requirements
• WHO – Laboratory Accreditation Standards

Version: 1.0

Approval Section

Annexures

Annexure-1: Laboratory Qualification Log

Annexure-2: Laboratory Audit Report

Annexure-3: Laboratory Qualification Certificate

Annexure-4: Accreditation Verification Log

Annexure-5: Non-Compliance Log

Revision History

For more SOPs visit: Pharma SOP