the performance of the machines does not affect the quality of the aerosol products, ensuring that all performance data meets the required specifications.

Health and Safety Officer: Ensures that safety protocols are followed during the operation of the machines, particularly in relation to high-speed and pressurized operations.

4. Accountability

The Manufacturing Manager is accountable for ensuring that this SOP is followed and that the performance of aerosol manufacturing machines is effectively monitored throughout the production process. The overall compliance with this SOP is under the supervision of the Quality Assurance (QA) Manager.

5. Procedure

5.1. Monitoring Key Machine Parameters

1. During production, monitor the following machine parameters to ensure consistent performance:
   • Filling volume or weight (for filling machines)
   • Crimping pressure (for crimping machines)
   • Valve integrity and leak testing (for valve testing machines)
   • Temperature, pressure, and cycle time (for all machines)
2. Use automated monitoring systems where available to track machine performance and record data in real time.
3. Ensure that any manual monitoring is done according to the machine’s operating manual, and that measurements are taken at regular intervals during the production run.
4. Record all machine parameters and performance data in the Machine Performance Log (Annexure-1) for traceability.

5.2. Identifying Performance Deviations

1. Monitor machine performance continuously and compare recorded data with predefined performance specifications and tolerances.
2. If any parameter deviates from the acceptable range (e.g., overfilling, underfilling, incorrect crimping pressure), stop the machine immediately and investigate the cause of the deviation.
3. Common performance deviations include:
   • Inconsistent filling volumes or weights
   • Improper sealing or crimping
   • Machine jams or stoppages
   • Variation in pressure or temperature settings
4. Record any deviations in the Performance Deviation Report (Annexure-2) and detail the immediate corrective actions taken.

5.3. Corrective Actions and Process Adjustments

1. Upon detecting a performance deviation, follow these steps:
   • Stop the machine immediately to prevent further product defects or damage.
   • Investigate the cause of the deviation. Common causes include:
     • Incorrect machine settings
     • Wear and tear of components
     • Environmental factors such as temperature or humidity
     • Operator error
   • Implement corrective actions based on the root cause analysis. Possible actions include recalibrating the machine, adjusting settings, replacing faulty components, or retraining operators.
   • Once corrective actions have been implemented, verify the machine performance by running a test cycle and ensuring that the machine operates within the required parameters.
   • Document the corrective actions taken and the results in the Performance Deviation Report (Annexure-2).

5.4. Post-Production Performance Review

1. Once the production run is complete, conduct a thorough review of the machine’s performance data, including any deviations and corrective actions taken.
2. Evaluate whether the performance of the machine met the required quality standards and production goals.
3. Provide feedback to the Production and Maintenance teams about any recurring performance issues and recommend any changes to the machine setup or maintenance procedures to improve future production runs.
4. Record the post-production performance review in the Machine Performance Review Report (Annexure-3).

5.5. Routine Performance Monitoring

1. Perform regular checks of the machine performance according to the maintenance schedule (e.g., weekly, monthly).
2. Compare performance data against historical data to identify any trends or potential areas for improvement.
3. Schedule maintenance or calibration if performance data consistently shows deviations or decreased efficiency.
4. Log all routine performance checks in the Routine Performance Check Log (Annexure-4).

5.6. Documentation and Record-Keeping

1. Ensure that all performance monitoring activities, including pre-production checks, deviations, corrective actions, and post-production reviews, are accurately documented and stored.
2. Maintain the machine performance logs and reports for the required retention period to comply with company policies and regulatory requirements.
3. Ensure that all records are available for internal and external audits as required.

6. Abbreviations

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

7. Documents

1. Machine Performance Log (Annexure-1)
2. Performance Deviation Report (Annexure-2)
3. Machine Performance Review Report (Annexure-3)
4. Routine Performance Check 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: Machine Performance Log

Machine ID	Parameter	Value	Operator Name	Time
F-12345	Filling Volume	200ml	Rajesh Patel	06/02/2025

Annexure-2: Performance Deviation Report

Batch No.	Deviation Description	Corrective Action	Operator Name
12345	Underfilling	Adjusted filler settings	Rajesh Patel

Annexure-3: Machine Performance Review Report

Batch No.	Review Date	Performance Outcome	Comments
12345	06/02/2025	Pass	No issues

Annexure-4: Routine Performance Check Log

Machine ID	Check Type	Performed By	Date
F-12345	Routine Speed Test	Rajesh Patel	06/02/2025

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 monitoring and corrective actions	To comply with updated GMP regulations	Anjali Sharma	Page 1	[Ref Point]	Updated procedures