1) SOP for Handling Deviations and Incidents

2) Purpose

The purpose of this Standard Operating Procedure (SOP) is to establish procedures for identifying, documenting, and investigating deviations, incidents, or non-conformances that occur during the manufacturing process in the pharmaceutical industry.

3) Scope

This SOP applies to all manufacturing and quality assurance personnel involved in the production of pharmaceutical products within the facility.

4) Responsibilities

• Production Personnel: Responsible for identifying and reporting deviations and incidents during the manufacturing process.
• QA Personnel: Responsible for overseeing the documentation, investigation, and resolution of deviations and incidents.
• Supervisors: Responsible for ensuring compliance with this SOP and facilitating communication between departments.

5) Procedure

1. Identification of Deviations and Incidents
   1. All personnel involved in the manufacturing process must be vigilant in identifying any deviations or incidents that occur.
   2. Examples of deviations include deviations from standard operating procedures (SOPs), batch records, and manufacturing instructions.
   3. Examples of incidents include equipment malfunctions, power failures, and safety issues.
2. Immediate Response
   1. Upon identification of a deviation or incident, the responsible personnel must immediately notify their supervisor and the QA department.
   2. If necessary, halt the affected process to prevent further impact on product quality or safety.
   3. Document the initial details of the deviation or incident, including the date, time, location, and description of the event.
3. Documentation
   1. Complete a deviation or incident report form with all relevant details, including the affected batch or product, involved personnel, and initial observations.
   2. Ensure the report is signed and dated by the personnel involved and their supervisor.
   3. Submit the completed report to the QA department for review.
4. Investigation
   1. QA personnel initiate a thorough investigation to determine the root cause of the deviation or incident.
   2. Gather and review all relevant documents, records, and data related to the event.
   3. Interview involved personnel to obtain additional information and insights.
   4. Use root cause analysis tools such as fishbone diagrams, Pareto analysis, and process mapping to identify the root cause.
   5. Document all findings and conclusions in the investigation report.
5. Corrective and Preventive Actions (CAPA)
   1. Based on the investigation findings, develop a CAPA plan to address the root cause and prevent recurrence of the deviation or incident.
   2. Ensure the CAPA plan includes specific actions, responsibilities, and timelines for implementation.
   3. Communicate the CAPA plan to all relevant personnel and departments.
   4. Monitor the implementation of CAPA and verify its effectiveness through follow-up inspections and testing.
6. Final Documentation and Reporting
   1. Ensure all documentation related to the deviation or incident, including the initial report, investigation findings, and CAPA actions, is complete and accurate.
   2. File the documentation in the designated location for future reference and regulatory audits.
   3. Prepare summary reports of deviation trends and CAPA effectiveness for periodic review by QA management.
7. Communication and Training
   1. Communicate the findings and corrective actions from the investigation to all relevant personnel and departments.
   2. Provide training or updates to personnel if the investigation identifies changes in procedures or practices.
   3. Encourage open communication and feedback to continuously improve the deviation and incident handling process.

6) Abbreviations, if any

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

7) Documents, if any

• Deviation Report Forms
• Incident Report Forms
• Investigation Reports
• CAPA Documentation
• Summary Reports

8) Reference, if any

• Current Good Manufacturing Practice (cGMP) guidelines
• FDA Guidance for Industry: Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production
• Company-specific quality management policies

9) SOP Version

Version 1.0