Pharmaceutical Deviation and Non-Conformance Investigation Checklist
Systematic deviation investigation protects product quality and patient safety. This checklist guides thorough investigation of production deviations, laboratory errors, and quality events per FDA 21 CFR 211.192 requirements.
- Industry: Pharmaceutical & Life Sciences
- Frequency: Per Deviation Event
- Estimated Time: 30-60 minutes
- Role: QA Manager / Production Supervisor
- Total Items: 31
- Compliance: FDA 21 CFR 211.192 - Production Record Review and Unexplained Discrepancies, FDA Guidance for Industry - Investigating Out-of-Specification Test Results (2006), EU GMP Chapter 8 - Complaints, Quality Defects and Product Recalls, ICH Q10 Section 3.1.1 Pharmaceutical Quality System Elements
Event Description and Containment
Document the deviation event and immediate containment.
- Deviation event fully described: what, when, where, who discovered, and by whom?
- Immediate containment actions taken and documented?
- Affected batch placed on hold pending investigation outcome?
- Scope of potential impact (which batches, products, equipment) determined?
- Required notifications made to QA, production management, and other stakeholders?
Root Cause Investigation
Document root cause analysis.
- All relevant data and evidence gathered and preserved?
- Timeline of events created?
- Systematic RCA tool applied (5-Why, Fishbone, FMEA, FTA)?
- Root cause hypotheses systematically tested and eliminated?
- Other products, processes, or areas potentially affected assessed?
Product Quality Impact Assessment
Assess impact on product quality and patient safety.
- Impact on Critical Quality Attributes (CQAs) assessed?
- Additional testing or analysis performed to characterize quality impact?
- Impact on product stability assessed?
- Patient safety risk from deviation evaluated?
- Retained samples tested for additional characterization?
Batch Disposition
Document batch disposition decision.
- Batch disposition (approve, reject, hold) justified with documented rationale?
- QA (and QP for EU) approval obtained for disposition decision?
- Other potentially impacted batches assessed for disposition?
- Product recall assessment completed if distributed product affected?
- Regulatory notification requirement (Field Alert, MDR, expedited report) assessed?
CAPA and Prevention
Document corrective and preventive actions.
- CAPA initiated with actions addressing identified root cause?
- SOP revision initiated if process gap contributed to deviation?
- Retraining action initiated if human error involved?
- Engineering or systemic controls considered to prevent recurrence?
- Effectiveness check scheduled for CAPA?
Closure and Reporting
Close investigation with complete documentation.
- Investigation closed within required timeframe per procedure?
- Batch record updated with deviation number and reference?
- Complete investigation report with all evidence documented?
- Deviation data captured for Annual Product Quality Review (APQR)?
- Regulatory notification submitted if required?
- Investigation report signed by QA and relevant department heads?
Related Pharmaceutical Life Sciences Checklists
- Pharmaceutical Data Integrity and ALCOA Plus Compliance Checklist
- Pharmaceutical Change Control Review and Approval Checklist
- Pharmaceutical CAPA Review and Effectiveness Check Checklist
- Pharmaceutical Data Integrity and ALCOA+ Compliance Audit Checklist
- Pharmaceutical QC Laboratory Inspection Checklist
- Pharmaceutical Microbiological Contamination Testing Checklist
- Pharmaceutical Water System Inspection Checklist
- Pharmaceutical Supplier Qualification Audit Checklist
Related Quality Systems Checklists
- Pharmaceutical CAPA Review and Effectiveness Check Checklist - FREE Download
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Why Use This Pharmaceutical Deviation and Non-Conformance Investigation Checklist?
This pharmaceutical deviation and non-conformance investigation checklist helps pharmaceutical & life sciences teams maintain compliance and operational excellence. Designed for qa manager / production supervisor professionals, this checklist covers 31 critical inspection points across 6 sections. Recommended frequency: per deviation event.
Ensures compliance with FDA 21 CFR 211.192 - Production Record Review and Unexplained Discrepancies, FDA Guidance for Industry - Investigating Out-of-Specification Test Results (2006), EU GMP Chapter 8 - Complaints, Quality Defects and Product Recalls, ICH Q10 Section 3.1.1 Pharmaceutical Quality System Elements. Regulatory-aligned for audit readiness and inspection documentation.
Frequently Asked Questions
What does the Pharmaceutical Deviation and Non-Conformance Investigation Checklist cover?
This checklist covers 31 inspection items across 6 sections: Event Description and Containment, Root Cause Investigation, Product Quality Impact Assessment, Batch Disposition, CAPA and Prevention, Closure and Reporting. It is designed for pharmaceutical & life sciences operations and compliance.
How often should this checklist be completed?
This checklist should be completed per deviation event. Each completion takes approximately 30-60 minutes.
Who should use this Pharmaceutical Deviation and Non-Conformance Investigation Checklist?
This checklist is designed for QA Manager / Production Supervisor professionals in the pharmaceutical & life sciences industry. It can be used for self-assessments, team audits, and regulatory compliance documentation.
Can I download this checklist as a PDF?
Yes, this checklist is available as a free PDF download. You can also use it digitally in the POPProbe mobile app for real-time data capture, photo documentation, and automatic reporting.