including measuring and weighing devices, are properly calibrated and maintained for accurate batch yield monitoring.

4. Accountability

The Manufacturing Manager is accountable for ensuring that batch yield is monitored during the production process in compliance with this SOP. The overall compliance with this SOP is overseen by the Quality Assurance (QA) Manager.

5. Procedure

5.1. Pre-Production Preparation

1. Ensure that the production team is aware of the batch yield targets for the specific aerosol batch being produced.
2. Ensure that all necessary materials, including raw materials, propellants, and aerosol containers, are available and ready for production.
3. Prepare the necessary equipment for monitoring batch yield, including:
   • Scales or weighing devices
   • Flow meters or volume measurement tools
   • Batch yield recording forms or logs
   • PPE, including gloves, goggles, and lab coats
4. Verify that all measurement tools and equipment are calibrated and functioning correctly.

5.2. Monitoring Batch Yield During Production

1. At the beginning of production, record the total amount of raw materials and propellants used in the batch. This information will be used as the baseline for calculating the batch yield.
2. During production, continuously monitor the amount of materials used at each stage, including filling, crimping, and any other steps relevant to aerosol manufacturing.
3. For each production stage:
   • Measure the amount of material dispensed into each aerosol can (e.g., fill weight for liquid components).
   • Monitor and document the quantity of propellant dispensed during filling.
   • Record the amount of aerosol containers used in the batch.
4. Compare the actual yield at each stage with the expected yield. The expected yield should be calculated based on the initial quantities of materials and the product specifications (e.g., number of cans, expected fill volume). Any discrepancies should be recorded.
5. If using automated systems for monitoring, ensure that the system is accurately tracking material usage and batch yield.

5.3. Post-Production Yield Analysis

1. After production is complete, calculate the final batch yield by comparing the total quantity of finished product with the amount of raw materials used during production.
2. Document the results in the Batch Yield Log (Annexure-1), including:
   • Total raw materials used
   • Total number of aerosol cans produced
   • Expected yield based on production plans
   • Actual yield
   • Yield efficiency percentage (Actual Yield / Expected Yield)
3. If the actual yield is significantly lower or higher than expected:
   • Investigate the cause of the discrepancy (e.g., overfill, underfill, spillage, inaccurate measuring equipment).
   • Take corrective actions as necessary to adjust the process or equipment settings.
   • Document any corrective actions in the Corrective Action Log (Annexure-2).
4. Provide a summary of the batch yield analysis to the QC team for review.

5.4. Calibration and Maintenance of Equipment

1. Ensure that all equipment used for monitoring batch yield, including scales, flow meters, and volume measuring tools, is regularly calibrated according to the manufacturer’s specifications.
2. Perform routine maintenance on equipment to ensure accurate readings during production.
3. Document all calibration and maintenance activities in the Equipment Calibration Log (Annexure-3) and the Equipment Maintenance Log (Annexure-4).

5.5. Documentation and Record-Keeping

1. Document all batch yield monitoring activities in the Batch Yield Log (Annexure-1), including the amount of raw materials used, the number of cans produced, and any deviations from expected yield.
2. Ensure that any discrepancies or corrective actions are documented in the Reconciliation Log (Annexure-5).
3. Store all batch yield records in the document management system, ensuring they are available for future reference and audits.

5.6. Safety and Environmental Considerations

1. Ensure that all personnel involved in batch yield monitoring wear appropriate PPE to prevent exposure to materials and ensure safety during the process.
2. Follow all safety guidelines for handling materials, especially propellants and pressurized aerosol containers, during production and monitoring.
3. Ensure that any waste generated during the batch production process, including unused materials or non-conforming products, is disposed of according to environmental and safety regulations.

6. Abbreviations

• GMP: Good Manufacturing Practice
• QC: Quality Control
• PPE: Personal Protective Equipment
• SOP: Standard Operating Procedure

7. Documents

1. Batch Yield Log (Annexure-1)
2. Corrective Action Log (Annexure-2)
3. Equipment Calibration Log (Annexure-3)
4. Equipment Maintenance Log (Annexure-4)
5. Reconciliation Log (Annexure-5)

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: Batch Yield Log

Batch Number	Raw Materials Used (kg)	Cans Produced	Expected Yield	Actual Yield	Yield Efficiency (%)	Operator Name	Remarks
Batch-001	200 kg	1000 cans	950 cans	1000 cans	105.3%	Rajesh Patel	Excess fill detected

Annexure-2: Corrective Action Log

Batch Number	Issue Date	Issue Description	Corrective Action	Operator Name
Batch-001	06/02/2025	Excess yield	Adjusted filling machine settings	Rajesh Patel

Annexure-3: Equipment Calibration Log

Equipment ID	Calibration Date	Calibration Results	Operator Name	Remarks
FILL-001	06/02/2025	Pass	Rajesh Patel	No adjustments required

Annexure-4: Equipment Maintenance Log

Equipment ID	Maintenance Date	Tasks Performed	Operator Name	Remarks
FILL-001	06/02/2025	Cleaned and calibrated	Rajesh Patel	No issues found

Annexure-5: Reconciliation Log

Batch Number	Material Received	Material Used	Material Remaining	Operator Name	Remarks
Batch-001	200 kg	190 kg	10 kg	Rajesh Patel	All materials accounted for

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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 batch yield monitoring procedures	To comply with updated GMP regulations	Anjali Sharma	Page 1	[Ref Point]	Updated procedures