Aerosol: SOP for Formulation Development of Aerosol Products – V 2.0
SOP for Formulation Development of Aerosol Products
| Department |
Aerosol |
| SOP No. |
SOP/Aerosol/011/2025 |
| Supersedes |
SOP/Aerosol/011/2022 |
| Page No. |
Page 1 of Y |
| Issue Date |
06/02/2025 |
| Effective Date |
16/02/2025 |
| Review Date |
06/02/2028 |
1. Purpose
This Standard Operating Procedure (SOP) defines the process for the formulation development of aerosol products. It ensures that the formulation of aerosol products is done in a controlled, compliant, and reproducible manner to achieve the desired product performance, quality, and regulatory compliance. This SOP outlines the key steps involved in the formulation development process, from initial concept through testing and optimization.
2. Scope
This procedure applies to all personnel involved in the development of aerosol formulations at [Company Name]. It covers the formulation design, material selection, development, testing, and optimization processes for aerosol products. This SOP does not apply to the manufacturing process or finished product packaging.
3. Responsibilities
- Formulation Development Team: Responsible for formulating aerosol products, conducting necessary testing, and optimizing formulations based on performance criteria and regulatory guidelines.
- Quality Control (QC) Team: Responsible for ensuring the accuracy and compliance of testing results, ensuring formulations meet required quality specifications.
- Production Personnel: Responsible for assisting in the transfer of formulation from lab-scale to pilot-scale, and ensuring compliance with manufacturing standards during the scale-up process.
- Regulatory Affairs Team: Responsible for ensuring that aerosol formulations meet the regulatory requirements for safety, efficacy, and quality.
4. Accountability
The Research and Development (R&D) Manager is accountable for ensuring that this SOP is followed during the formulation development process and that any deviations are addressed. The overall compliance to this SOP is under the supervision of the Quality Assurance (QA) Manager.
5. Procedure
5.1. Formulation Design
- Begin by defining the formulation objectives, including the desired characteristics of the final product, such as stability, performance, and delivery characteristics.
- Select raw materials, including propellants, active ingredients, solvents, and excipients, based on compatibility, safety, and regulatory compliance. Perform compatibility studies to assess interactions between ingredients.
- Ensure that all selected materials comply with relevant regulatory requirements, including material safety data sheets (MSDS), and are sourced from approved suppliers.
5.2. Laboratory Scale Development
- Prepare the formulation on a small laboratory scale, following the proposed formulation recipe.
- Use appropriate equipment, such as a magnetic stirrer or homogenizer, to ensure uniform mixing of materials. Maintain controlled conditions such as temperature and humidity to ensure consistency in product characteristics.
- Perform in-process testing during the development phase to monitor key parameters such as viscosity, stability, and pH. Adjust the formulation based on test results to meet the desired product specifications.
5.3. Pilot-Scale Development
- Once the formulation has been developed and optimized at the laboratory scale, scale up to a pilot batch.
- During pilot-scale development, replicate the conditions used at the laboratory scale, ensuring that mixing, temperature, and pressure parameters are controlled.
- Conduct further testing on the pilot batches to assess batch-to-batch consistency, product stability, and performance under actual manufacturing conditions.
5.4. Testing and Evaluation
- Test the formulations for key performance parameters, such as:
- Spray pattern and droplet size distribution
- Viscosity and stability
- Uniformity of content
- Compatibility with packaging components (e.g., can, valve, actuator)
- Evaluate the product’s stability under accelerated and real-time conditions to determine shelf life and expiration date.
- Ensure that the formulation meets the required safety and regulatory standards, including testing for toxicity, irritation, and other safety assessments as per local and international regulations.
5.5. Optimization and Finalization
- Based on test results, make any necessary adjustments to the formulation to improve product performance, stability, or manufacturability.
- Once the formulation meets all requirements, finalize the formulation and proceed with regulatory submissions for approval.
- Prepare detailed documentation of the development process, including formulation records, testing results, and stability data, for regulatory review and internal records.
5.6. Corrective and Preventive Actions (CAPA)
- If any issues arise during formulation development, initiate corrective actions to resolve the issue. For example, if a formulation fails stability testing, rework the formulation to improve stability or adjust ingredients.
- Implement preventive actions to ensure that similar issues do not arise in future development processes, such as revising formulation practices or improving ingredient sourcing practices.
- Document all corrective and preventive actions in the CAPA Log (Annexure-1) and track 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
- Formulation Development Record (Annexure-2)
- Batch Testing Log (Annexure-3)
- CAPA Log (Annexure-1)
- 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
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Prepared By |
Checked By |
Approved By |
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11. Annexures
Annexure-1: CAPA Log
| Issue |
Root Cause |
Corrective Action |
Preventive Action |
Follow-up Date |
| Formulation instability |
Improper mixing |
Adjusted mixing procedure |
Standardized mixing time |
06/03/2025 |
Annexure-2: Formulation Development Record
| Material Name |
Batch No. |
Ingredients |
Testing Date |
Results |
| Example Material |
12345 |
Active Ingredient, Solvent |
06/02/2025 |
Pass |
Annexure-3: Batch Testing Log
| Batch No. |
Test Parameter |
Test Result |
Test Date |
Tested By |
| 12345 |
Viscosity |
Pass |
06/02/2025 |
Rajesh Patel |
Annexure-4: Material Compatibility Log
| Material Name |
Compatibility Test |
Test Result |
Test Date |
Tested By |
| Example Material |
Compatibility with Solvent A |
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 formulation process |
To comply with updated GMP regulations |
Anjali Sharma |
Page 1 |
[Ref Point] |
Updated procedures |