SOP Guide for Pharma

Tablets: SOP for Conducting Risk Assessments for New Tablet Products – V 2.0

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Tablets: SOP for Conducting Risk Assessments for New Tablet Products – V 2.0

Standard Operating Procedure for Conducting Risk Assessments for New Tablet Products

Department Tablet
SOP No. SOP/TAB/223/2025
Supersedes SOP/TAB/223/2022
Page No. Page 1 of 5
Issue Date 01/03/2026
Effective Date 06/03/2026
Review Date 01/03/2027

1. Purpose

This SOP outlines the process for conducting risk assessments for new tablet products. The goal is to identify and mitigate potential risks to product quality, safety, and regulatory compliance during the development and manufacturing processes.

2. Scope

This SOP applies to the risk assessment of all new tablet products in the product development phase. It covers all stages, including formulation development, scale-up, manufacturing, and regulatory compliance.

3. Responsibilities

4. Accountability

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

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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.
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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

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

9. SOP Version

Version: 2.0

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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
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