maintained regularly to ensure accurate measurements and data.

4. Accountability

The Manufacturing Manager is accountable for ensuring that in-process control activities are performed and documented according to 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 all necessary forms, logs, or software systems for documentation are prepared and ready for use before the start of production.
2. Verify that all personnel involved in in-process control activities are trained on the requirements for documentation and data recording.
3. Prepare necessary equipment for the in-process control activities, including inspection tools, sampling devices, and measurement instruments.
4. Ensure that all equipment is calibrated and verified for accuracy prior to the start of production.

5.2. Documenting In-Process Control Activities

1. During production, document all relevant control activities, including:
   • Material checks (e.g., verification of raw material weights, propellant quantities)
   • Process parameter monitoring (e.g., temperature, pressure, flow rate)
   • Sampling for quality control testing
2. For each activity:
   • Record the date, time, and the operator performing the activity.
   • Ensure that data is entered into the appropriate log or document, such as the In-Process Control Log (Annexure-1), or the Electronic Batch Records (EBR).
   • Document any observed deviations from normal operating conditions, including any corrective actions taken, in the Deviation Log (Annexure-2).
3. Ensure that each data entry is clear, legible, and signed off by the responsible operator or supervisor.
4. If using automated systems for documentation:
   • Ensure that the system is working properly and is regularly checked for accuracy.
   • Verify that data entries are complete and comply with production specifications.

5.3. Post-Production Documentation Review

1. Once production is complete, the documentation of in-process control activities should be reviewed by the QC team for completeness and accuracy.
2. If any discrepancies or non-conformances are identified:
   • Notify the production team and investigate the cause of the issue.
   • Ensure that corrective actions are taken and properly documented in the Corrective Action Log (Annexure-3).
3. Ensure that all documentation is signed off by the responsible personnel and stored for future reference or audits.

5.4. Calibration and Maintenance of Equipment

1. Ensure that all equipment used for in-process control activities (e.g., measuring instruments, sampling tools) is calibrated according to the company’s calibration schedule.
2. Perform routine maintenance on equipment to ensure its accuracy and functionality during production.
3. Document all calibration and maintenance activities in the Equipment Calibration Log (Annexure-4) and the Equipment Maintenance Log (Annexure-5).

5.5. Documentation and Record-Keeping

1. Document all in-process control activities in the specified logs (e.g., In-Process Control Log, Deviation Log, Corrective Action Log), ensuring that data is complete, accurate, and easy to trace.
2. Ensure that all records are reviewed by the QC team to verify that they meet the required specifications and that any deviations are addressed.
3. Store all records in the document management system in a secure and organized manner, ensuring that they are readily available for future reference and audits.

5.6. Safety and Environmental Considerations

1. Ensure that all personnel involved in documenting in-process control activities wear appropriate PPE, such as gloves, goggles, and lab coats.
2. Follow safety protocols when handling raw materials, equipment, and aerosol containers during production and documentation activities.
3. Ensure that any waste generated during the production process is properly disposed of according to safety and environmental regulations.

6. Abbreviations

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

7. Documents

1. In-Process Control Log (Annexure-1)
2. Deviation Log (Annexure-2)
3. Corrective Action Log (Annexure-3)
4. Equipment Calibration Log (Annexure-4)
5. Equipment Maintenance 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: In-Process Control Log

Activity	Test Date	Operator Name	Result	Remarks
Material Check	06/02/2025	Rajesh Patel	Pass	No issues found

Annexure-2: Deviation Log

Activity	Deviation Description	Corrective Action	Operator Name	Remarks
Fill Check	Underfill detected	Adjusted filling process	Rajesh Patel	Issue resolved

Annexure-3: Corrective Action Log

Activity	Issue Date	Issue Description	Corrective Action	Operator Name
Fill Check	06/02/2025	Underfill detected	Adjusted machine settings	Rajesh Patel

Annexure-4: Equipment Calibration Log

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

Annexure-5: 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

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