1) SOP for Handling of Deviations and Incidents

2) Purpose

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

3) Scope

This SOP applies to all deviations, incidents, or non-conformances identified within the manufacturing, testing, or packaging processes of pharmaceutical products.

4) Responsibilities

• Production Department: Responsible for identifying and documenting deviations or incidents during operations.
• Quality Assurance (QA) Department: Responsible for investigating deviations or incidents, determining root causes, and implementing corrective actions.
• Quality Control (QC) Department: Responsible for performing initial assessments and providing data related to deviations or incidents.
• Regulatory Affairs: Responsible for ensuring compliance with regulatory reporting requirements.

5) Procedure

1. Identification of Deviations or Incidents
   1. Immediately report any deviation, incident, or non-conformance to the QA department.
   2. Document details including date, time, location, personnel involved, and initial assessment of impact.
2. Initial Assessment
   1. QA conducts an initial assessment to determine the severity and potential impact on product quality and patient safety.
   2. Assign a classification (critical, major, minor) based on risk assessment and predefined criteria.
3. Investigation
   1. Formulate an investigation team including representatives from production, QA, QC, and relevant departments.
   2. Conduct a thorough investigation to identify root causes using tools such as fishbone diagrams, 5 Whys, or other problem-solving techniques.
   3. Document investigation findings, conclusions, and corrective actions proposed.
4. Corrective and Preventive Actions (CAPA)
   1. Develop and implement corrective actions to address immediate concerns and prevent recurrence.
   2. Monitor effectiveness of corrective actions through follow-up and verification.
   3. Implement preventive actions to mitigate potential future occurrences.
5. Documentation and Reporting
   1. Prepare a detailed deviation or incident report including investigation findings, actions taken, and outcomes.
   2. Review and approve the report by relevant departments and management.
   3. Submit required reports to regulatory authorities as per regulatory reporting requirements.

6) Abbreviations, if any

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

7) Documents, if any

• Deviation or Incident Report Form
• Investigation Report
• CAPA Plan and Tracking Log
• Regulatory Reporting Forms

8) Reference, if any

• Good Manufacturing Practice (GMP) Guidelines
• ICH Q9: Quality Risk Management
• Company-specific deviation management procedures and guidelines

9) SOP Version

Version 1.0