OBJECTIVE:

• To describe the procedure for identifying, documenting, investigating, and reporting any incident or deviation that may impact product quality, Good Manufacturing Practices (GMP) compliance, safety, or regulatory requirements within the pharmaceutical manufacturing facility.

SCOPE:

• Applicable to all departments of the manufacturing site such as Production, Quality Assurance (QA), Quality Control (QC), Engineering, Microbiology, Warehouse, Utility, Human Resources (HR), and Administration.
• Covers all unplanned or abnormal events, including documentation, process, equipment, and facility-related incidents.

RESPONSIBILITIES:

User / Area In-charge:

• Identify and report any incident immediately to the Department Head and QA.
• Record initial details in the Incident Reporting Form.
• Implement immediate containment action, if applicable.

User Department Head:

• Verify and confirm the details of the reported incident.
• Support QA in initial evaluation and risk classification.
• Ensure required resources for investigation and Corrective and Preventive Action (CAPA) implementation.

 Designee Quality Assurance:

• Assign a unique Incident Number as per numbering system.
• Evaluate and classify the incident (Minor / Major / Critical).
• Lead the investigation and ensure completion within defined timelines.
• Coordinate with relevant departments for CAPA identification and verification.
• Ensure incident closure and update the Incident Register.
• File and archive original incident records in the controlled document archive.
• Maintain electronic backup and retrieval log.
• Ensure record retention and destruction per Document Control SOP.

Head Quality Assurance:

• Review the investigation report and approve classification and CAPA.
• Ensure effectiveness of CAPA and compliance to timelines.
• Escalate critical incidents to Site Head and Regulatory Affairs when applicable.
• Approve closure of each incident and authorize trend reports.

DEFINATIONS:

• Incident: Any unplanned event that deviates from approved process, procedure, or expected operation.
• Critical Incident: Event that may result in product recall, regulatory action, patient safety risk, or significant GMP non-compliance.
•  Major Incident: Event having potential impact on product quality or data integrity requiring CAPA and QA approval before release.
•  Minor Incident: Event with no product quality impact but requiring documentation for traceability and system improvement.

PROCEDURE:

Incident Identification:

• Any staff observing an abnormal situation shall stop the activity (if required for safety) and inform the area supervisor and QA.
• The User shall complete Incident Reporting Form within 24 hours.

Incident Numbering System:

Each incident shall be uniquely numbered as follows: INC/XX/YYY. Where:

• INC – Incident
• XX – Last two digits of the calendar year
• YYY – Sequential number starting from 001 each year
• Example: INC/25/004 – Indicates 4th incident reported in 2025.

Incident Classification:

Critical Incident: Events having actual or potential impact on product quality, patient safety, or regulatory compliance.

• • • Examples:
      • Product mix-up or cross-contamination
      • Data falsification or manipulation.
      • Incorrect batch release.

Action:

• Stop the concerned activity immediately.
• Inform QA Head and Site Head without delay.
• Begin investigation and containment within 2 hours of detection.

Major Incident: Events that may have significant effect on product quality or GMP system but no immediate safety risk.

• • Examples:
    • Equipment breakdown during batch processing
    • Missed calibration or validation schedule
    • Heating, Ventilation, and Air Conditioning (HVAC) or utility parameter drift affecting environment.

Action:

• Inform QA within 8 hours of occurrence.
• Start investigation within 24 hours.
• Implement CAPA before next batch or activity.

Minor Incident: Events with no direct impact on product quality or compliance, but requiring documentation for traceability.

• • Examples:
    • Minor power fluctuation
    • Spillage with no contamination risk
    • Typographical/documentation errors
    • Minor housekeeping issues

Action:

• Inform QA within 24 hours.
• Record and close within 48 hours.
• No formal CAPA unless repetition observed.

Investigation and Root Cause Analysis:

• QA shall initiate investigation within 2 working days of incident reporting.
•  Tools such as 5-Why or Fishbone Diagram shall be used.
• Investigation must include:
• • Description of incident
  • Immediate and long-term impact on product and system
  • Root cause and corrective actions.

 Corrective and Preventive Action (CAPA):

• Corrective and Preventive Action (CAPA) shall be raised and tracked under the CAPA management system.
•  Implementation responsibility shall lie with concerned department.
• Verification and closure responsibilities shall lie with QA.

Review and Closure:

• Designee QA shall ensure all required documents (incident form, investigation, CAPA) are complete.

 Closure timeline: normally ≤ 30 calendar days; justified extensions with approval from Head-QA.

• Designee QA shall update the Incident Log.

Trending and Reporting:

• Designee QA shall perform quarterly trend analysis to identify repetitive or high-risk areas.
•  Trends and statistics shall be reviewed in Quality Management Review (QMR) meetings.

Archival and Record Retention:

• All original incident reports, investigation forms, and CAPA records shall be archived in the QA Document Control Room.

Retention Period:

• Minimum 5 years from closure date or one year after product shelf life as applicable. Access to archived documents shall be controlled by the Designee QA.

REFERENCE:

• EU-GMP Part I, Chapter 1 – Pharmaceutical Quality System
• ICH Q10 – Pharmaceutical Quality System

RECORDS:

 REVISION HISTORY: