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
- Quality Assurance (QA): Responsible for leading the risk assessment process, ensuring that risks are identified, evaluated, and mitigated. QA is also responsible for maintaining records of risk assessments.
- Production Team: Responsible for providing process data and assisting in identifying risks in the production environment.
- Regulatory Affairs: Responsible for ensuring that the risk assessment process meets regulatory requirements.
- All Personnel: Required to participate in risk assessments when necessary and to implement corrective actions as part of the risk mitigation process.
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.
5. Procedure
5.1 Risk Identification
- Identify potential risks at every stage of the tablet manufacturing process, from raw material procurement to final product release.
- 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.
- 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
- 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
- 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.
- 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
- 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
- For high-priority risks (e.g., high RPN), immediate corrective actions should be taken, such as revising SOPs or updating equipment maintenance protocols.
- Document all mitigation strategies and their implementation (Annexure-1).
5.4 Risk Review and Monitoring
- 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.
- Monitor the effectiveness of the implemented mitigation strategies through periodic audits, testing, and process performance metrics.
- If new risks arise or existing risks change in scope or severity, repeat the risk assessment process to update the risk mitigation plan.
- Document all reviews and updates to the risk mitigation plan (Annexure-2).
5.5 Reporting
- All identified risks, assessments, and mitigation actions should be reported to senior management and relevant departments.
- 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
- 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).
- 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
- Risk Assessment Report (Annexure-1)
- Risk Review Report (Annexure-2)
- 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 |