SOP Guide for Pharma

Tablets: SOP for Risk Assessment in Tablet Manufacturing Processes – V 2.0

Auditor

Tablets: SOP for Risk Assessment in Tablet Manufacturing Processes – V 2.0

Standard Operating Procedure for Risk Assessment in Tablet Manufacturing Processes

Department Tablet
SOP No. SOP/TAB/183/2025
Supersedes SOP/TAB/183/2022
Page No. Page 1 of 6
Issue Date 01/03/2026
Effective Date 06/03/2026
Review Date 01/03/2027

1. Purpose

To define the procedure for conducting risk assessments within tablet manufacturing processes, identifying potential risks that could impact product quality, safety, and compliance with regulatory standards.

2. Scope

This SOP applies to all tablet manufacturing processes, including raw material handling, production, packaging, and final inspection. It covers the identification, assessment, and mitigation of risks associated with these processes.

3. Responsibilities

4. Accountability

The QA Manager is accountable for ensuring that risk assessments are conducted as part of routine operations and that all identified risks are mitigated in a timely and effective manner.

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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).
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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

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7. Documents

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

8. References

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
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