Standard Operating Procedure for Incident Management System in Ocular Dosage Form Manufacturing

1) Purpose

The purpose of this SOP is to establish a structured Incident Management System (IMS) to promptly detect, assess, report, investigate, and mitigate incidents occurring during the manufacturing of ocular dosage forms, including eye drops, ointments, gels, and inserts. This ensures that incidents are managed effectively to minimize impact on product quality, safety, and regulatory compliance.

2) Scope

This SOP applies to all personnel involved in the manufacturing process of ocular dosage forms, including operators, supervisors, quality assurance, and management. It covers incidents related to equipment malfunction, process deviations, environmental issues, and personnel safety concerns.

3) Responsibilities

The Incident Management Team (IMT) is responsible for implementing and overseeing the IMS. The Quality Assurance (QA) department leads incident investigations, while department heads and personnel are responsible for reporting incidents promptly and implementing corrective actions.

4) Procedure

4.1 Incident Detection and Reporting

1. Immediately report any incident or deviation from normal operations to the designated supervisor or QA representative.
2. Use the Incident Report Form to document incident details, including date, time, location, description, and initial assessment of impact.

4.2 Incident Assessment and Classification

1. Convene the IMT to assess the severity and potential impact of the incident on product quality, safety, and regulatory compliance.
2. Classify the incident based on predefined criteria (e.g., critical, major, minor) to determine the level of response required.

4.3 Incident Investigation

1. Assign a qualified investigator to conduct a thorough investigation into the root cause(s) of the incident.
2. Gather evidence, interview relevant personnel, and review documentation to identify contributing factors.
3. Document the investigation findings, including the root cause analysis and corrective actions recommended.

4.4 Incident Mitigation and Corrective Actions

1. Implement immediate corrective actions to mitigate the impact of the incident and prevent recurrence.
2. Develop a Corrective and Preventive Action (CAPA) plan based on investigation findings to address underlying causes.
3. Assign responsibilities and timelines for CAPA implementation and verification.

4.5 Incident Resolution and Closure

1. Monitor the effectiveness of implemented corrective actions through follow-up assessments and verification.
2. Close the incident report once all corrective actions are successfully implemented and verified.
3. Archive incident documentation, including investigation reports, CAPA records, and follow-up assessments.

5) Abbreviations, if any

SOP: Standard Operating Procedure
IMS: Incident Management System
IMT: Incident Management Team
QA: Quality Assurance
CAPA: Corrective and Preventive Action

6) Documents, if any

1. Incident Report Form
2. Investigation Report
3. Corrective and Preventive Action (CAPA) Plan
4. Follow-up Assessment Records
5. Training Records related to incident management

7) Reference, if any

Good Manufacturing Practices (GMP) guidelines
International Conference on Harmonization (ICH) guidelines Q9 and Q10
Company-specific quality policies and procedures

8) SOP Version

Version 1.0