Team: Responsible for maintaining and troubleshooting manufacturing equipment to ensure that it operates within the required parameters.

Health and Safety Officer: Ensures that all process parameters are maintained in a safe range to prevent accidents or product contamination.

4. Accountability

The Manufacturing Manager is accountable for ensuring that this SOP is followed and that process parameters are properly maintained during aerosol production. Compliance with this SOP is under the supervision of the Quality Assurance (QA) Manager.

5. Procedure

5.1. Setup of Manufacturing Process Parameters

1. Prior to starting the manufacturing process, ensure that all equipment is properly calibrated and set to the specified process parameters.
2. Review the formulation or product specification to determine the required process parameters (e.g., temperature, pressure, mixing speed, time).
3. Set the equipment according to the product specification, ensuring that all relevant parameters are configured correctly before production begins.
4. Verify that all safety settings are correctly configured to prevent equipment malfunction or deviations during production.

5.2. Monitoring of Manufacturing Process Parameters

1. During the production process, continuously monitor key process parameters using the relevant instruments or sensors (e.g., temperature sensors, pressure gauges, flow meters).
2. Ensure that the process parameters remain within the specified ranges. If any parameter deviates from the defined limits, take corrective action immediately.
3. Log all monitored data regularly in the Process Monitoring Log (Annexure-1), including time, parameter readings, and operator details.
4. If any process parameter is outside the acceptable range, stop the process and investigate the cause. Adjust the equipment settings or perform any necessary corrective actions to bring the parameter back within range.

5.3. Adjustment of Process Parameters

1. If any process parameter deviates beyond the acceptable range, adjust the equipment settings to restore the parameter to the required value. For example:
   • Adjust temperature if it is too high or too low.
   • Increase or decrease pressure if it deviates from the set point.
   • Adjust mixing speed or time to ensure proper formulation.
2. Once adjustments are made, restart the process and continue to monitor the parameters until they stabilize within the desired range.
3. Document any adjustments made in the Adjustment Log (Annexure-2), including the reason for the adjustment and the actions taken.

5.4. In-Process Testing and Verification

1. Conduct in-process testing to verify that the product meets quality specifications during production. This may include:
   • Checking for consistency in the formulation
   • Testing physical properties like viscosity or particle size (for suspensions)
   • Performing weight or volume checks (for filling processes)
2. If in-process testing identifies any issues, stop the production process and investigate the cause. Make necessary adjustments to the process parameters and perform re-testing until the product meets specifications.
3. Record all in-process testing results and any corrective actions in the In-Process Testing Log (Annexure-3).

5.5. Post-Production Review

1. After the production process is complete, review all process data and in-process test results to ensure that the product has met all quality specifications.
2. Verify that all critical process parameters were maintained within the defined range throughout the production cycle. Ensure that any deviations were documented and that corrective actions were implemented effectively.
3. Prepare a final report summarizing the process parameter data, in-process tests, and any deviations or adjustments made during production. This report should be filed with the Batch Record.

5.6. Safety and Environmental Considerations

1. Ensure that all process parameters are maintained within safe operating ranges to prevent any risks related to temperature, pressure, or other critical factors.
2. Ensure that safety measures are in place to protect operators from exposure to hazardous substances, particularly during the formulation and filling stages.
3. Ensure that the clean room or manufacturing environment is maintained according to safety standards to prevent contamination and protect personnel from exposure to chemicals or aerosols.

5.7. Documentation and Record-Keeping

1. Document all process parameter settings, adjustments, and in-process test results in the appropriate logs and Batch Records. This documentation should include:
   • Process Monitoring Log (Annexure-1)
   • Adjustment Log (Annexure-2)
   • In-Process Testing Log (Annexure-3)
2. Ensure that all records are stored according to the company’s document retention policy and are available for future audits or inspections.

6. Abbreviations

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

7. Documents

1. Process Monitoring Log (Annexure-1)
2. Adjustment Log (Annexure-2)
3. In-Process Testing Log (Annexure-3)

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 Pharmacopoeia (Ph. Int.) – Aerosol Delivery

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Process Monitoring Log

Batch No.	Parameter Monitored	Reading	Time	Operator Name
12345	Temperature	25°C	06/02/2025 10:00 AM	Rajesh Patel

Annexure-2: Adjustment Log

Batch No.	Parameter Adjusted	Adjustment Made	Reason for Adjustment	Operator Name
12345	Pressure	Increased by 5 psi	Deviation from set pressure	Rajesh Patel

Annexure-3: In-Process Testing Log

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

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