Standard Operating Procedure for Incident Investigation and Reporting in Microbiology Lab

Purpose

The purpose of this Standard Operating Procedure (SOP) is to establish procedures for investigating and reporting microbial contamination incidents in the pharmaceutical manufacturing facility.

Scope

This SOP applies to all personnel involved in incident investigation and reporting, including microbiologists, quality assurance personnel, and production supervisors.

Responsibilities

• Quality Assurance (QA) Department: Responsible for overseeing the implementation and compliance of this SOP.
• Microbiology Laboratory Supervisor: Responsible for coordinating incident investigations and reporting findings to relevant stakeholders.
• Production Personnel: Responsible for reporting any suspected microbial contamination incidents to the QA department for investigation.

Procedure

1. Initial Assessment:
   • Upon discovery of a potential microbial contamination incident, initiate an initial assessment to determine the scope and severity of the incident.
   • Isolate affected areas or materials to prevent further spread of contamination and ensure product integrity.
2. Incident Investigation:
   • Conduct a thorough investigation to identify the root cause(s) of the microbial contamination incident.
   • Collect relevant information, including environmental monitoring data, production records, and microbiological testing results.
3. Corrective Actions:
   • Implement immediate corrective actions to address any identified causes of microbial contamination and mitigate associated risks.
   • Develop and implement long-term corrective and preventive actions (CAPAs) to prevent recurrence of similar incidents in the future.
4. Documentation and Reporting:
   • Document all findings, actions taken, and outcomes of the incident investigation in a detailed report.
   • Report the investigation findings to relevant stakeholders, including senior management, regulatory authorities, and affected departments.
5. Follow-Up and Monitoring:
   • Monitor the effectiveness of implemented corrective and preventive actions through ongoing surveillance and review.
   • Periodically review incident reports and investigation findings to identify trends and opportunities for continuous improvement.

Abbreviations

• SOP: Standard Operating Procedure
• QA: Quality Assurance
• CAPA: Corrective and Preventive Actions

Documents

• Incident Investigation Report Forms
• Corrective Action Plans (CAPAs)
• Incident Trend Analysis Reports

Reference

United States Pharmacopoeia (USP) General Chapter Microbial Control and Monitoring of Aseptic Processing Environments

SOP Version

Version 1.0