accurate reconciliation of in-process components.

Health and Safety Officer: Ensures that safety protocols are followed when handling materials and managing any discrepancies, particularly when dealing with hazardous materials or propellants.

4. Accountability

The Manufacturing Manager is accountable for ensuring that the reconciliation of in-process components is performed according to this SOP. The overall compliance with this SOP is overseen by the Quality Assurance (QA) Manager.

5. Procedure

5.1. Pre-Reconciliation Preparation

1. Ensure that all in-process components (raw materials, propellants, containers, etc.) are available and ready for reconciliation at each stage of production.
2. Ensure that accurate records are maintained for the quantities of materials used, received, and dispensed, including batch numbers, lot numbers, and storage locations.
3. Verify that the production team has accurately recorded the quantities of components used and the amount remaining at each stage of production.
4. Prepare necessary equipment for the reconciliation process, including:
   • Inventory management software or tracking tools
   • Reconciliation forms or logs
   • PPE, including gloves, goggles, and lab coats

5.2. Reconciliation Process

1. At the beginning of each production run, the following components should be reconciled:
   • Raw materials (e.g., active ingredients, excipients)
   • Propellants (e.g., butane, propane)
   • Aerosol containers
   • Valves, actuators, and other packaging components
2. During the production run:
   • Track the usage of each material and component using inventory management systems or manual logs.
   • At each stage of production (e.g., after filling, crimping), check that the amount of material used matches the expected usage based on production plans and batch sizes.
3. If discrepancies are identified (e.g., excess or shortage of materials):
   • Immediately notify the production supervisor and initiate a root cause analysis to identify and resolve the issue.
   • Record any discrepancies in the Reconciliation Discrepancy Log (Annexure-1) and take corrective action as needed.
4. At the end of the production run, perform a final reconciliation:
   • Compare the initial quantities of components with the final usage amounts to ensure that all materials were accounted for correctly.
   • Ensure that the remaining materials are returned to inventory and that all discrepancies are resolved.
   • Document the results of the reconciliation in the In-Process Reconciliation Log (Annexure-2).

5.3. Post-Reconciliation Actions

1. If the reconciliation is successful:
   • Proceed with the next production batch, ensuring that the reconciliation process is repeated at each stage of production.
   • Ensure that all reconciliation data is stored in the document management system for future audits.
2. If discrepancies are found and not resolved:
   • Investigate the cause of the discrepancy (e.g., miscalculation, incorrect material usage, spillage).
   • Take corrective actions, such as adjusting material quantities, re-educating staff, or improving inventory control practices.
   • Document the corrective actions taken in the Corrective Action Log (Annexure-3).

5.4. Calibration and Maintenance of Equipment

1. Ensure that all equipment used for tracking and reconciling in-process components (e.g., scales, flow meters, inventory management software) is calibrated and maintained according to the manufacturer’s specifications.
2. Perform routine maintenance on equipment used for reconciliation to ensure accuracy and reliability.
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 reconciliation activities, including the material quantities received, used, and remaining, in the In-Process Reconciliation Log (Annexure-2).
2. Ensure that all records, including discrepancy logs and corrective action reports, are reviewed by the QC team to ensure that the reconciliation process meets the required standards.
3. Store all 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 the reconciliation process wear appropriate PPE to prevent exposure to materials, including raw materials and propellants.
2. Follow all safety protocols when handling hazardous materials or dealing with discrepancies in material usage, especially when dealing with pressurized containers or toxic substances.
3. Ensure proper disposal of any waste generated during the reconciliation process, including non-conforming components and leftover materials, in accordance with environmental and safety regulations.

6. Abbreviations

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

7. Documents

1. In-Process Reconciliation Log (Annexure-2)
2. Reconciliation Discrepancy Log (Annexure-1)
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: Reconciliation Discrepancy Log

Component	Discrepancy Description	Corrective Action	Operator Name	Remarks
Propellant	Excess usage	Adjusted machine settings	Rajesh Patel	No further issues found

Annexure-2: In-Process Reconciliation Log

Component	Received Quantity	Used Quantity	Remaining Quantity	Operator Name	Remarks
Propellant	500 L	450 L	50 L	Rajesh Patel	Checked and recorded

Annexure-3: Corrective Action Log

Component	Issue Date	Issue Description	Corrective Action	Operator Name
Propellant	06/02/2025	Excess usage detected	Adjusted filling process	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 reconciliation process	To comply with updated GMP regulations	Anjali Sharma	Page 1	[Ref Point]	Updated procedures