risk assessment process for new tablet products. The R&D, Regulatory Affairs, and Production teams contribute to identifying risks and developing risk mitigation strategies.

5. Procedure

5.1 Initial Risk Identification

1. Review the product development plan, including the formulation, process design, and manufacturing specifications, to identify potential risks associated with the new tablet product (Annexure-1).
2. Consider the following potential risk areas:
   • Formulation instability
   • Raw material variability
   • Equipment limitations
   • Environmental factors (e.g., temperature, humidity)
   • Regulatory compliance issues
   • Manufacturing process variability
3. Document all identified risks in the Risk Assessment Report (Annexure-2).

5.2 Risk Assessment Methodology

1. Use risk assessment tools such as Failure Mode and Effects Analysis (FMEA), Hazard Analysis and Critical Control Points (HACCP), or Risk Priority Number (RPN) to quantify and prioritize risks (Annexure-3).
2. Assign a risk score to each identified risk based on the likelihood of occurrence and the potential impact on product quality, safety, or regulatory compliance.
3. Evaluate the severity, detectability, and likelihood of each risk and document the findings in the Risk Assessment Matrix (Annexure-4).

5.3 Risk Mitigation Strategy

1. For each high-priority risk, develop a mitigation strategy to reduce the likelihood or impact of the risk. This may include:
   • Process optimization
   • Improved raw material quality control
   • Additional testing or validation
   • Training for personnel
2. Document the risk mitigation strategies in the Risk Mitigation Plan (Annexure-5).
3. Assign responsibilities to the relevant teams for implementing mitigation actions and set timelines for completion.

5.4 Review and Approval of Risk Assessment

1. Once the risk assessment and mitigation strategies are finalized, review the entire process for accuracy and completeness.
2. Submit the risk assessment report, risk matrix, and mitigation plan to the QA Manager for approval (Annexure-6).
3. Upon approval, the risk assessment documentation should be integrated into the product development plan and shared with all relevant teams.

5.5 Ongoing Risk Monitoring

1. Monitor the effectiveness of the mitigation strategies during the product development and manufacturing phases.
2. Perform periodic reviews of the risk assessment to identify new risks or areas for improvement as the product progresses through the development cycle (Annexure-7).
3. Update the risk assessment and mitigation plan as necessary and ensure that all changes are documented and communicated to the relevant teams.

5.6 Documentation and Record Keeping

1. Maintain all risk assessment documentation, including risk matrices, mitigation plans, and review records, for a minimum of 5 years or as required by regulatory guidelines (Annexure-8).
2. Ensure all records are securely stored and easily accessible for future audits or inspections.

6. Abbreviations

• SOP: Standard Operating Procedure
• QA: Quality Assurance
• QC: Quality Control
• FMEA: Failure Mode and Effects Analysis
• HACCP: Hazard Analysis and Critical Control Points
• RPN: Risk Priority Number

7. Documents

1. Risk Assessment Report (Annexure-1)
2. Risk Assessment Matrix (Annexure-2)
3. Risk Assessment Methodology (Annexure-3)
4. Risk Mitigation Plan (Annexure-4)
5. Risk Assessment Review and Approval Log (Annexure-5)
6. Ongoing Risk Monitoring and Review Log (Annexure-6)
7. Risk Documentation and Record Keeping Log (Annexure-7)

8. References

• 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals (US FDA)
• ISO 9001 – Quality Management Systems
• ICH Q9 – Quality Risk Management

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Risk Assessment Report

Risk ID	Description	Impact	Probability	Risk Priority Number (RPN)	Mitigation Plan
R001	Granulation process instability	High	Medium	12	Optimize process parameters and validate equipment

Annexure-2: Risk Assessment Matrix

Risk	Severity	Likelihood	RPN
Raw material variability	High	Medium	15

Annexure-3: Risk Assessment Methodology

Method	Description
FMEA	Identify failure modes and evaluate the potential impact and likelihood of each mode.

Annexure-4: Risk Mitigation Plan

Risk	Mitigation Action	Responsible Person	Completion Date
Granulation process variability	Improve equipment calibration and process monitoring	John Smith	10/03/2026

Annexure-5: Risk Assessment Review and Approval Log

Review Date	Reviewed By	Approval Status
01/03/2026	John Doe	Approved

Annexure-6: Ongoing Risk Monitoring and Review Log

Review Date	Reviewed By	Risk Monitored	Status
01/04/2026	Jane Doe	Granulation instability	Ongoing

Annexure-7: Risk Documentation and Record Keeping Log

Record Type	Retention Period	Stored By
Risk Assessment Records	5 years	QA Team

Revision History:

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
01/01/2024	1.0	Initial SOP creation	New process	QA Head
01/02/2025	2.0	Updated risk assessment methodology and monitoring procedures	Annual review	QA Head
01/03/2026	3.0	Enhanced risk documentation and review process	Updated process and compliance	QA Head