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

1) Purpose

The purpose of this SOP is to establish a systematic approach for identifying, assessing, managing, and mitigating risks associated with the manufacturing of ocular dosage forms to ensure product quality and patient safety.

2) Scope

This SOP applies to all processes, activities, and personnel involved in the manufacturing of ocular dosage forms, including eye drops, ointments, gels, and inserts.

3) Responsibilities

The Quality Assurance (QA) department is responsible for overseeing the risk management system. All relevant departments, including production, quality control, and regulatory affairs, must participate in risk management activities and comply with this SOP.

4) Procedure

4.1 Risk Identification

1. Identify potential risks throughout the entire manufacturing process, from raw material receipt to final product distribution.
2. Use various methods for risk identification, such as brainstorming sessions, checklists, and historical data analysis.
3. Document identified risks in a risk register, detailing the risk description, potential impact, and likelihood of occurrence.

4.2 Risk Assessment

1. Assess the identified risks using qualitative and quantitative methods to determine their severity and probability.
2. Use risk assessment tools such as Failure Modes and Effects Analysis (FMEA), Hazard Analysis and Critical Control Points (HACCP), and risk matrices.
3. Assign risk ratings based on the assessment, categorizing them as low, medium, or high risk.

4.3 Risk Control

1. Develop risk control strategies to mitigate identified risks, prioritizing high-risk areas.
2. Implement risk control measures, such as process modifications, additional testing, and enhanced monitoring.
3. Document the implemented risk control measures and their effectiveness in reducing risk.

4.4 Risk Communication

1. Communicate identified risks and control measures to all relevant personnel and departments.
2. Ensure that risk-related information is documented and accessible to all stakeholders involved in the manufacturing process.

4.5 Risk Review and Monitoring

1. Regularly review and update the risk register to reflect any changes in the manufacturing process or new risks identified.
2. Monitor the effectiveness of implemented risk control measures through periodic reviews and audits.
3. Adjust risk control strategies as needed based on monitoring results and feedback from personnel.

4.6 Risk Documentation

1. Maintain comprehensive documentation of all risk management activities, including risk assessments, control measures, and review findings.
2. Ensure that risk management documentation is accurate, up-to-date, and readily available for regulatory inspections.

5) Abbreviations, if any

SOP: Standard Operating Procedure
QA: Quality Assurance
FMEA: Failure Modes and Effects Analysis
HACCP: Hazard Analysis and Critical Control Points

6) Documents, if any

1. Risk register
2. Risk assessment reports
3. Risk control documentation
4. Risk review and monitoring reports

7) Reference, if any

International Council for Harmonisation (ICH) Q9: Quality Risk Management
ISO 14971: Medical Devices – Application of Risk Management to Medical Devices

8) SOP Version

Version 1.0