Standard Operating Procedure for Risk Management in Manufacturing Processes

1) Purpose

The purpose of this SOP is to establish procedures for identifying, assessing, controlling, and mitigating risks associated with manufacturing processes within the pharmaceutical facility.

2) Scope

This SOP applies to all personnel involved in manufacturing operations, quality assurance, and risk management within the pharmaceutical manufacturing facility.

3) Responsibilities

3.1 Quality Assurance (QA) Team

• Oversee implementation of risk management processes.
• Review and approve risk assessments and mitigation plans.

3.2 Manufacturing and Engineering Teams

• Identify and assess risks associated with manufacturing processes.
• Implement controls and mitigation measures.

4) Procedure

4.1 Risk Identification

1. Identify potential risks associated with manufacturing processes.
2. Document identified risks in a risk register.

4.2 Risk Assessment

1. Evaluate identified risks based on severity, likelihood, and detectability.
2. Prioritize risks for further assessment and mitigation.

4.3 Risk Control Measures

1. Develop and implement controls to mitigate identified risks.
2. Monitor effectiveness of implemented controls.

4.4 Risk Review and Documentation

1. Periodically review risk register and update as necessary.
2. Document risk assessments, mitigation plans, and review outcomes.

5) Abbreviations, if any

SOP: Standard Operating Procedure; QA: Quality Assurance

6) Documents, if any

• Risk Register
• Risk Assessment Reports
• Mitigation Plans

7) Reference, if any

ICH Q9: Quality Risk Management
FDA Guidance for Industry: Risk-Based Approach to Pharmaceutical CGMPs

8) SOP Version

Version 1.0