manufacturing.

4. Accountability

The Research and Development (R&D) Manager is accountable for ensuring that this SOP is followed during the propellant selection process. The overall compliance to this SOP is under the supervision of the Quality Assurance (QA) Manager.

5. Procedure

5.1. Identification of Formulation Requirements

1. Define the specific requirements of the aerosol product, including the type of product (e.g., topical spray, inhaler), desired pressure, required shelf life, and compatibility with the formulation.
2. Ensure that the product design, such as spray pattern, force, and ease of use, is taken into account while selecting the propellant.
3. Consider the target market and any specific environmental or regulatory requirements that may affect propellant selection.

5.2. Selection Criteria for Propellants

1. Solubility: Ensure the selected propellant is compatible with the active ingredients in the formulation. The propellant should be able to solvate or disperse the active ingredient effectively.
2. Pressure: The propellant should generate the appropriate pressure within the can to ensure proper functioning of the aerosol product during its use.
3. Stability: The selected propellant must maintain its stability over the product’s shelf life, without undergoing chemical changes that could affect the formulation’s efficacy or safety.
4. Environmental Impact: Choose a propellant that complies with environmental regulations, such as being non-ozone depleting and having low global warming potential (e.g., HFCs, butane, propane).
5. Toxicity: Ensure the propellant is safe for the intended use and will not cause harm to the user or the environment. It should also comply with the relevant safety standards and guidelines for inhalation exposure.
6. Regulatory Compliance: Select a propellant that meets the regulatory requirements of the region where the product will be marketed. This includes compliance with the US FDA, EMA, and local regulations on aerosol products.

5.3. Testing and Validation

1. Conduct laboratory-scale testing to assess the selected propellant’s compatibility with the formulation and evaluate its performance in terms of aerosol delivery, stability, and user experience.
2. Perform additional testing, including:
   • Spray pattern and droplet size analysis
   • Stability testing under accelerated conditions
   • Compatibility with container and valve system
3. Perform environmental testing to verify that the selected propellant does not negatively impact the environment, including compatibility with the canister material and valve system.
4. Ensure that the selected propellant meets all regulatory and safety requirements for the intended aerosol product.

5.4. Selection of Alternate Propellants

1. If the primary propellant does not meet the necessary criteria, consider alternate propellants that may better suit the product requirements.
2. Evaluate potential alternatives based on the same selection criteria, including solubility, pressure, stability, environmental impact, and regulatory compliance.

5.5. Documentation and Review

1. Document the selection process, including rationale for choosing the selected propellant, the testing results, and any regulatory approvals obtained.
2. Prepare a Propellant Selection Report (Annexure-1) and submit it for review and approval by the formulation team, regulatory affairs team, and quality control team.
3. Ensure all documentation is retained according to company procedures and regulatory requirements for audit purposes.

5.6. Corrective and Preventive Actions (CAPA)

1. If issues are identified with the selected propellant (e.g., poor performance, stability, or regulatory non-compliance), initiate corrective actions to select an alternate propellant or adjust the formulation.
2. Preventive actions should include improving the propellant selection process, conducting more comprehensive testing, or enhancing training for personnel involved in propellant selection.
3. Document all corrective and preventive actions in the CAPA Log (Annexure-2) and monitor the effectiveness of the actions taken.

6. Abbreviations

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

7. Documents

1. Propellant Selection Report (Annexure-1)
2. CAPA Log (Annexure-2)
3. Propellant Testing Log (Annexure-3)
4. Material Compatibility 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

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Propellant Selection Report

Formulation Name	Selected Propellant	Test Results	Reason for Selection	Approval Date
Example Aerosol	Propellant X	Pass	Meets pressure and stability requirements	06/02/2025

Annexure-2: CAPA Log

Issue	Root Cause	Corrective Action	Preventive Action	Follow-up Date
Propellant instability	Improper mixing	Reformulated with better solvent	Improved mixing process	06/03/2025

Annexure-3: Propellant Testing Log

Test Parameter	Test Result	Test Date	Tested By
Viscosity	Pass	06/02/2025	Rajesh Patel

Annexure-4: Material Compatibility Log

Material Name	Compatibility Test	Test Result	Test Date	Tested By
Propellant X	Compatibility with formulation	Pass	06/02/2025	Ravi Kumar

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 propellant selection process	To comply with updated GMP regulations	Anjali Sharma	Page 1	[Ref Point]	Updated procedures