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“headline”: “SOP for Non-Compliance Escalation and CAPA”,
“description”: “This SOP defines procedures for non-compliance escalation and Corrective and Preventive Action (CAPA) in clinical trials. It ensures timely detection, reporting, root cause analysis, escalation, and implementation of CAPA in compliance with FDA, EMA, CDSCO, WHO, and ICH GCP requirements.”,
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Standard Operating Procedure for Non-Compliance Escalation and CAPA

Purpose

The purpose of this SOP is to establish procedures for identifying, escalating, and addressing non-compliance in clinical trials through Corrective and Preventive Actions (CAPA). It ensures that deviations and violations are promptly managed to protect subject safety, maintain data integrity, and comply with global regulatory requirements.

Scope

This SOP applies to sponsors, investigators, CROs, QA, and vendors involved in clinical research. It covers detection, categorization, escalation, root cause analysis, CAPA planning, implementation, verification, and closure of non-compliance issues across all trial-related activities.

Responsibilities

• Sponsor: Defines escalation framework and ensures oversight of CAPA processes.
• Investigators: Report deviations and implement corrective actions at the site level.
• QA: Monitors non-compliance reporting, performs root cause analysis, and approves CAPA plans.
• CROs: Ensure site compliance and escalate significant deviations to the sponsor.
• Vendors: Report and document non-compliance issues in outsourced services.

Accountability

The Sponsor is accountable for ensuring non-compliance is escalated and resolved. QA is accountable for verifying CAPA implementation and maintaining inspection readiness.

Procedure

1. Detection of Non-Compliance
1.1 Identify non-compliance through monitoring visits, audits, inspections, or daily trial activities.
1.2 Document findings in Non-Compliance Log (Annexure-1).

2. Categorization
2.1 Classify non-compliance as minor, major, or critical.
2.2 Define escalation timelines based on severity (e.g., immediate for critical, 7 days for major).

3. Escalation Process
3.1 Notify site PI, Sponsor, and QA within defined timelines.
3.2 For critical issues, escalate immediately to regulatory authorities if subject safety is at risk.
3.3 Maintain Escalation Log (Annexure-2).

4. Root Cause Analysis
4.1 Perform analysis using tools like 5-Why or Fishbone Diagram.
4.2 Record analysis in Root Cause Analysis Log (Annexure-3).

5. CAPA Planning and Implementation
5.1 Define corrective actions to address immediate issues.
5.2 Define preventive actions to avoid recurrence.
5.3 Document CAPA plan in CAPA Log (Annexure-4).

6. Verification and Closure
6.1 QA verifies CAPA effectiveness within defined timelines.
6.2 Close CAPA only when compliance is restored and preventive measures are effective.

7. Documentation and Retention
7.1 Maintain all CAPA and escalation records in TMF.
7.2 Records must be available for inspection.

Abbreviations

• SOP: Standard Operating Procedure
• CAPA: Corrective and Preventive Action
• QA: Quality Assurance
• PI: Principal Investigator
• CRO: Contract Research Organization
• TMF: Trial Master File

Documents

1. Non-Compliance Log (Annexure-1)
2. Escalation Log (Annexure-2)
3. Root Cause Analysis Log (Annexure-3)
4. CAPA Log (Annexure-4)

References

• ICH E6(R2/R3) – Handling Non-Compliance
• FDA – Non-Compliance and CAPA Guidance
• EMA – Clinical Trial CAPA Management
• CDSCO – Deviation and CAPA Oversight
• WHO – Non-Compliance Management in GCP

Version: 1.0

Approval Section

Annexures

Annexure-1: Non-Compliance Log

Annexure-2: Escalation Log

Annexure-3: Root Cause Analysis Log

Annexure-4: CAPA Log

Revision History

For more SOPs visit: Pharma SOP