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
- R&D Team: Responsible for identifying potential risks during the formulation and development phases and conducting initial risk assessments.
- Quality Assurance (QA) Team: Responsible for overseeing the risk assessment process, ensuring compliance with regulatory requirements, and reviewing risk mitigation strategies.
- Regulatory Affairs Team: Ensures that the risk assessment process complies with relevant regulatory guidelines and provides support for risk-related documentation.
- Production Team: Responsible for providing input regarding manufacturing-related risks and assessing operational impacts during scale-up and manufacturing trials.
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.
5. Procedure
5.1 Initial Risk Identification
- 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).
- 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
- Document all identified risks in the Risk Assessment Report (Annexure-2).
5.2 Risk Assessment Methodology
- 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).
- 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.
- 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
- 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
- Document the risk mitigation strategies in the Risk Mitigation Plan (Annexure-5).
- Assign responsibilities to the relevant teams for implementing mitigation actions and set timelines for completion.
5.4 Review and Approval of Risk Assessment
- Once the risk assessment and mitigation strategies are finalized, review the entire process for accuracy and completeness.
- Submit the risk assessment report, risk matrix, and mitigation plan to the QA Manager for approval (Annexure-6).
- 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
- Monitor the effectiveness of the mitigation strategies during the product development and manufacturing phases.
- 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).
- 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
- 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).
- 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
- Risk Assessment Report (Annexure-1)
- Risk Assessment Matrix (Annexure-2)
- Risk Assessment Methodology (Annexure-3)
- Risk Mitigation Plan (Annexure-4)
- Risk Assessment Review and Approval Log (Annexure-5)
- Ongoing Risk Monitoring and Review Log (Annexure-6)
- 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 |