Standard Operating Procedure for Discrepancy Investigation

Purpose

The purpose of this SOP is to establish procedures for the investigation and resolution of discrepancies identified during pharmaceutical distribution activities, ensuring timely identification of root causes and implementation of corrective actions to prevent recurrence.

Scope

This SOP applies to all personnel involved in discrepancy investigation processes, including quality assurance professionals, warehouse staff, and management personnel, within the distribution facility.

Responsibilities

• The Quality Assurance Manager is responsible for overseeing discrepancy investigation activities, ensuring compliance with regulatory requirements, and approving investigation reports and corrective actions.
• The Warehouse Supervisor is responsible for initiating and coordinating discrepancy investigations, assigning investigation tasks to relevant personnel, and ensuring timely resolution of identified issues.
• All personnel involved in discrepancy investigation are responsible for following procedures outlined in this SOP and providing accurate and timely information to support investigation efforts.

Procedure

1. Discrepancy Identification:
   • Identify and document any discrepancies or deviations observed during pharmaceutical distribution activities, including receipt, storage, handling, and shipment of products, using established documentation and reporting systems.
   • Classify discrepancies based on severity, impact on product quality or safety, and potential regulatory implications to prioritize investigation and resolution efforts accordingly.
2. Investigation Initiation:
   • Initiate a formal investigation for significant discrepancies or deviations that may impact product quality, safety, or regulatory compliance, assigning responsibility for investigation to qualified personnel with relevant expertise.
   • Document the initiation of the investigation, including the reason for investigation, scope of investigation, personnel assigned, and expected timeline for completion, to ensure transparency and accountability.
3. Root Cause Analysis:
   • Conduct a thorough root cause analysis to identify underlying factors contributing to the discrepancy, using appropriate investigative techniques such as 5 Whys, fishbone diagrams, or failure mode and effects analysis (FMEA).
   • Involve cross-functional teams and subject matter experts as needed to explore potential root causes from multiple perspectives and validate findings through data analysis, interviews, and documentation review.
4. Corrective Action Implementation:
   • Develop and implement corrective actions to address identified root causes and prevent recurrence of discrepancies, considering short-term containment measures and long-term corrective measures to address systemic issues.
   • Assign responsibility for implementing corrective actions to designated personnel, establish timelines and milestones for completion, and monitor progress to ensure timely and effective implementation of corrective measures.
5. Documentation and Reporting:
   • Document all investigation findings, including root cause analysis results, corrective actions implemented, and follow-up measures taken, in a formal investigation report, ensuring accuracy, completeness, and traceability of information.
   • Review and approve investigation reports by the Quality Assurance Manager or designated personnel, and distribute them to relevant stakeholders, including management, regulatory authorities, and affected parties, as required.

Abbreviations

• SOP – Standard Operating Procedure
• FMEA – Failure Mode and Effects Analysis

Documents

Reference documents related to discrepancy investigation may include:

• Discrepancy reporting forms
• Investigation initiation records
• Root cause analysis reports
• Corrective action plans
• Investigation summary reports

Reference

Good Distribution Practice Guidelines

SOP Version

Version 1.0