to product performance are appropriately mitigated.

Regulatory Affairs Team: Ensures that all identified risks comply with regulatory requirements and that the risk assessment meets the necessary legal and safety standards.

Manufacturing Team: Responsible for identifying risks in the manufacturing process, ensuring equipment and processes are adequately controlled, and proposing preventive actions to mitigate risks during production.

Management: Accountable for overseeing the risk assessment process, ensuring that all teams are involved, and reviewing and approving the final risk assessment report.

4. Accountability

The Product Development Manager is accountable for ensuring that this SOP is followed and that the risk assessment is conducted thoroughly during product development. The overall compliance with this SOP is under the supervision of the Quality Assurance (QA) Manager.

5. Procedure

5.1. Identification of Risks

1. Gather information on all components of the aerosol product, including active ingredients, excipients, propellants, packaging, and the delivery system (valve, actuator).
2. Identify potential risks related to the following areas:
   • Formulation Risks: Chemical instability, incompatibility between ingredients, adverse reactions between formulation and packaging materials.
   • Manufacturing Risks: Process variability, equipment malfunction, contamination risks, human error.
   • Packaging Risks: Leakage, corrosion, mechanical failure of the valve and actuator systems, incompatibility between formulation and packaging materials.
   • Regulatory Risks: Non-compliance with local or international regulations regarding formulation, labeling, or safety standards.
   • Delivery System Risks: Inconsistent spray pattern, clogging, incorrect particle size, inadequate delivery of the active ingredient.

5.2. Risk Evaluation and Assessment

1. Evaluate each identified risk in terms of its likelihood of occurrence and its potential impact on product safety, quality, and performance. The following criteria should be used:
   • Likelihood: The probability of the risk occurring (e.g., rare, unlikely, likely, very likely).
   • Impact: The potential severity of the risk if it were to occur (e.g., minor, moderate, major, catastrophic).
2. Assign a risk rating by multiplying the likelihood and impact scores to prioritize risks. This will help to focus efforts on the most critical risks.
3. Document the results of the risk evaluation in the Risk Assessment Log (Annexure-1). The log should include:
   • Description of the risk
   • Likelihood and impact rating
   • Risk level (e.g., low, medium, high)
   • Proposed mitigation strategies

5.3. Risk Mitigation Strategies

1. Develop and implement mitigation strategies for high-risk areas. Common strategies include:
   • Formulation adjustments (e.g., changing excipients or propellants to improve stability or compatibility)
   • Improving manufacturing processes (e.g., enhancing process control, conducting more frequent quality checks)
   • Improving packaging design (e.g., changing materials or modifying packaging to ensure proper sealing and prevent leakage)
   • Enhancing delivery system design (e.g., modifying the valve or actuator to prevent clogging or inconsistent spray patterns)
   • Ensuring regulatory compliance by incorporating safety data and performing regulatory filings where required.
2. For each identified risk, develop an action plan with assigned responsibilities, timelines, and success criteria.
3. Document all mitigation strategies and action plans in the Risk Mitigation Plan (Annexure-2).

5.4. Risk Review and Monitoring

1. Review the effectiveness of the risk mitigation strategies periodically throughout product development. Ensure that any new risks identified are incorporated into the ongoing risk assessment process.
2. Monitor the status of the action plans and update them if necessary based on new data or changes in the product development process.
3. Ensure that all testing, manufacturing, and packaging procedures are aligned with the identified risk levels and mitigation plans.

5.5. Documentation and Reporting

1. Document the entire risk assessment process, including the risk identification, evaluation, mitigation strategies, and review activities, in the Risk Assessment Report (Annexure-3).
2. Submit the report for review by the Management, Regulatory Affairs, and Quality Control teams.
3. Ensure that all risks and mitigation strategies are documented in compliance with regulatory requirements for product development and safety documentation.

5.6. Corrective and Preventive Actions (CAPA)

1. If issues are discovered during the product development process that were not anticipated in the risk assessment, initiate corrective actions to resolve these issues.
2. Implement preventive actions to ensure similar risks do not arise in future development projects. This may involve revising risk assessment protocols, changing development procedures, or improving team training on risk management.
3. Document all corrective and preventive actions in the CAPA Log (Annexure-4) and track the effectiveness of these actions.

6. Abbreviations

• GMP: Good Manufacturing Practice
• QC: Quality Control
• CAPA: Corrective and Preventive Actions
• R&D: Research and Development

7. Documents

1. Risk Assessment Log (Annexure-1)
2. Risk Mitigation Plan (Annexure-2)
3. Risk Assessment Report (Annexure-3)
4. CAPA Log (Annexure-4)

8. References

This SOP is based on the following regulatory guidelines and industry standards:

• Good Manufacturing Practice (GMP) Guidelines
• FDA Code of Federal Regulations (CFR) Title 21, Part 211
• ISO 9001:2015 – Quality Management Systems
• International Organization for Standardization (ISO) – Risk Management Guidelines

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 Log

Risk Description	Likelihood	Impact	Risk Rating	Mitigation Strategy
Formulation instability	Likely	Major	High	Adjust excipient concentrations

Annexure-2: Risk Mitigation Plan

Risk Description	Action Plan	Responsible Team	Timeline
Packaging failure	Switch to more compatible materials	Packaging Team	06/03/2025

Annexure-3: Risk Assessment Report

Formulation	Risk Identified	Risk Level	Mitigation Actions	Approval Date
Example Aerosol	Ingredient incompatibility	High	Reformulate with new excipient	06/02/2025

Annexure-4: CAPA Log

Issue	Root Cause	Corrective Action	Preventive Action	Follow-up Date
Packaging leakage	Inadequate sealing	Updated sealing process	Improved material inspection	06/03/2025

12. Revision History:

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By	Page No.	Ref. Point No.	Details of Revision
01/01/2024	V 1.0	Initial Release	First Issue	Anjali Sharma	Page 1	[Ref Point]	First Release
01/01/2025	V 2.0	Updated risk assessment process	To comply with updated GMP regulations	Anjali Sharma	Page 1	[Ref Point]	Updated procedures