Standard Operating Procedure for Risk Management

1) Purpose

The purpose of this SOP is to establish a procedure for the identification, assessment, and management of risks to ensure the quality and safety of pharmaceutical products.

2) Scope

This SOP applies to all processes, procedures, equipment, and systems within the manufacturing facility that may pose a risk to product quality or patient safety.

3) Responsibilities

The responsibilities for this SOP are divided among various roles:

3.1 Risk Management Team:

Responsible for conducting risk assessments and developing risk mitigation plans.

3.2 Department Managers:

Responsible for implementing risk mitigation plans within their departments.

3.3 Quality Assurance (QA) Manager:

Responsible for overseeing the risk management process and ensuring compliance with regulatory requirements.

4) Procedure

4.1 Identification of Risks:

4.1.1 Identify potential risks to product quality and patient safety.
4.1.2 Document identified risks using the Risk Assessment Form.

4.2 Risk Assessment:

4.2.1 Assess the likelihood and impact of identified risks.
4.2.2 Prioritize risks based on their assessed likelihood and impact.
4.2.3 Document the results of the risk assessment.

4.3 Risk Mitigation:

4.3.1 Develop risk mitigation plans for high-priority risks.
4.3.2 Implement risk mitigation plans promptly.
4.3.3 Monitor the effectiveness of risk mitigation plans and make adjustments as necessary.

4.4 Documentation and Review:

4.4.1 Document all steps of the risk management process, including identification, assessment, mitigation, and review.
4.4.2 Review risk management records regularly to ensure ongoing compliance.
4.4.3 Update risk assessments and mitigation plans as needed based on changes in processes, procedures, or equipment.

4.5 Communication:

4.5.1 Communicate identified risks and mitigation plans to relevant personnel.
4.5.2 Ensure all personnel understand their roles in managing and mitigating risks.
4.5.3 Document all communications related to risk management.

5) Abbreviations, if any

QA – Quality Assurance

6) Documents, if any

1. Risk Assessment Forms
2. Risk Mitigation Plans
3. Risk Management Logs

7) Reference, if any

1. FDA Guidance on Good Manufacturing Practices (GMP)
2. ICH Q9 Quality Risk Management

8) SOP Version

Version 1.0