operations and that all identified risks are mitigated in a timely and effective manner.

5. Procedure

5.1 Risk Identification

1. Identify potential risks at every stage of the tablet manufacturing process, from raw material procurement to final product release.
2. Risks should be categorized into the following areas:
   • Quality Risks: Risks that could affect the quality or efficacy of the product.
   • Safety Risks: Risks that could pose a threat to the safety of consumers or workers.
   • Compliance Risks: Risks that could lead to non-compliance with regulatory guidelines.
   • Operational Risks: Risks related to the manufacturing process, equipment, or staffing.
3. Use tools such as Failure Mode and Effects Analysis (FMEA) or Hazard Analysis and Critical Control Points (HACCP) to systematically identify risks.

5.2 Risk Assessment

1. Assess the identified risks based on their likelihood and severity. Use a risk matrix to evaluate each risk on the following scale:
   • Likelihood: Rare, Unlikely, Likely, Almost Certain
   • Severity: Minor, Moderate, Major, Critical
2. Determine the potential impact of each risk on product quality, safety, and regulatory compliance. For example, a risk identified as “likely” with “critical” severity requires immediate attention and mitigation.
3. Assign a risk priority number (RPN) to each identified risk using the formula:
   
   RPN = Likelihood x Severity x Detectability. The higher the RPN, the higher the priority for mitigation.

5.3 Risk Mitigation

1. Develop and implement strategies to mitigate or eliminate the identified risks. Mitigation strategies may include:
   • Process improvements or changes
   • Equipment upgrades or modifications
   • Increased training or awareness programs
   • Enhanced monitoring or quality control measures
2. For high-priority risks (e.g., high RPN), immediate corrective actions should be taken, such as revising SOPs or updating equipment maintenance protocols.
3. Document all mitigation strategies and their implementation (Annexure-1).

5.4 Risk Review and Monitoring

1. Conduct regular reviews of the risk assessment process to ensure that all risks are adequately mitigated and that new risks are identified as part of ongoing operations.
2. Monitor the effectiveness of the implemented mitigation strategies through periodic audits, testing, and process performance metrics.
3. If new risks arise or existing risks change in scope or severity, repeat the risk assessment process to update the risk mitigation plan.
4. Document all reviews and updates to the risk mitigation plan (Annexure-2).

5.5 Reporting

1. All identified risks, assessments, and mitigation actions should be reported to senior management and relevant departments.
2. Any significant changes to the risk profile or new risks identified should be communicated to relevant stakeholders, including the regulatory authorities if necessary.

5.6 Documentation and Record Keeping

1. Ensure that all risk assessment activities, including risk identification, assessment, and mitigation plans, are properly documented and stored in compliance with regulatory requirements (Annexure-3).
2. Maintain records of all risk assessments for a minimum of five years or as required by regulatory guidelines.

6. Abbreviations

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

7. Documents

1. Risk Assessment Report (Annexure-1)
2. Risk Review Report (Annexure-2)
3. Risk Mitigation Plan (Annexure-3)

8. References

• 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals (US FDA)
• ISO 9001 – Quality Management Systems
• ICH Q7 – Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients

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	Risk Description	Likelihood	Severity	RPN	Mitigation Plan
RISK-001	Tablet hardness variation	Likely	Major	12	Process review and equipment calibration

Annexure-2: Risk Review Report

Review ID	Review Date	Risk Updated	Action Taken	Next Review Date
REVIEW-001	01/04/2026	Tablet hardness risk	Implemented corrective action and monitoring	01/04/2027

Annexure-3: Risk Mitigation Plan

Mitigation Plan ID	Risk Addressed	Action Taken	Responsible Person	Completion Date
MIT-001	Tablet weight variation	Adjusted tablet press settings	John Doe	15/05/2026

Revision History:

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
01/01/2024	1.0	Initial Version	New SOP Creation	QA Head
01/02/2025	2.0	Updated risk assessment methodology	Clarified process for assessing and mitigating risks	QA Head