SOP for Managing Risks in Pharmaceutical Manufacturing

1) Purpose

To establish a systematic approach for identifying, assessing, controlling, and mitigating risks associated with pharmaceutical manufacturing processes.

2) Scope

This SOP applies to all risk management activities within the pharmaceutical manufacturing facility, specifically focusing on identifying and managing risks related to product quality, safety, and regulatory compliance.

3) Responsibilities

Quality Assurance: Responsible for overseeing the implementation of risk management activities.
Production Team: Responsible for identifying and reporting process-related risks.
Quality Control: Responsible for providing data and insights into potential quality risks.
Regulatory Affairs: Responsible for ensuring that risk management activities comply with regulatory requirements.

4) Procedure

1. Risk Identification:
   1. Conduct brainstorming sessions with relevant stakeholders to identify potential risks.
   2. Review historical data, incident reports, and complaints to identify recurring issues.
2. Risk Assessment:
   1. Evaluate identified risks based on severity, probability of occurrence, and detectability.
   2. Use risk assessment tools such as FMEA (Failure Modes and Effects Analysis) or HAZOP (Hazard and Operability Study) where applicable.
3. Risk Control and Mitigation:
   1. Develop risk control measures to mitigate identified risks.
   2. Implement preventive actions and controls to reduce the likelihood or impact of risks.
4. Risk Review and Monitoring:
   1. Regularly review and update risk assessments based on new data or changes in processes.
   2. Monitor effectiveness of risk controls and revise as necessary.

5) Abbreviations, if any

FMEA – Failure Modes and Effects Analysis

6) Documents, if any

• Risk Assessment Reports
• Preventive Action Plans
• Change Control Records

7) Reference, if any

ICH Q9: Quality Risk Management

8) SOP Version

Version 1.0