ensuring compliance with regulatory standards, and addressing any discrepancies found during reconciliation.

Warehouse Team: Responsible for verifying the quantity of materials used and providing records of material withdrawals for production.

4. Accountability

The Manufacturing Manager is accountable for ensuring that batch reconciliation is completed properly after each manufacturing batch. The overall compliance with this SOP is under the supervision of the Quality Assurance (QA) Manager.

5. Procedure

5.1. Collecting Batch Production Data

1. After the completion of each batch, collect the following production data:
   • Raw material consumption (including amounts of each material used)
   • Finished product yield (the number of units produced)
   • Any waste or by-product generated
   • Packaging materials used
2. Ensure that all data is accurately recorded in the Batch Production Record (BPR) (Annexure-1) for the specific batch.
3. The data should be collected from various sources, including production logs, material withdrawal records, and production machines.

5.2. Verifying Material Usage and Yields

1. Compare the actual material usage with the expected material consumption based on the batch record. The expected consumption should be derived from the formulation and the targeted yield.
2. Verify the number of finished products produced against the expected yield. Any differences should be recorded and investigated.
3. If any discrepancies are found in material usage or product yields, a deviation report should be generated (Annexure-2) and reviewed by the QA and QC teams.

5.3. Identifying Discrepancies

1. During the reconciliation process, discrepancies may be identified between the expected and actual product yield or material usage. These discrepancies can include:
   • Excess material consumption
   • Less product yield than expected
   • Excess waste or by-product generation
   • Packaging material discrepancies
2. Any discrepancies identified during reconciliation should be thoroughly investigated to determine their root cause. Potential causes may include equipment malfunction, human error, inaccurate weighing, or loss of material during transfer.
3. The investigation of discrepancies should be documented in the Deviation Report (Annexure-3), including details of the discrepancy, possible causes, and corrective actions taken.

5.4. Corrective Actions and Preventive Measures

1. Based on the findings from the investigation of discrepancies, appropriate corrective actions should be taken to address the issues and prevent recurrence. Corrective actions may include:
   • Adjustments to equipment settings or calibration
   • Changes in material handling procedures
   • Retraining of personnel
2. Implement preventive measures to ensure that similar discrepancies do not occur in future batches. These may include process improvements, updates to SOPs, or changes in monitoring procedures.
3. Document all corrective actions and preventive measures in the Corrective and Preventive Action (CAPA) Log (Annexure-4).

5.5. Final Batch Reconciliation Approval

1. Once the batch reconciliation process is completed and all discrepancies are resolved, the reconciliation records should be reviewed by the QA team.
2. Verify that all materials used, products manufactured, and packaging materials consumed are accurately accounted for and documented.
3. Once verified, the QA team should approve the batch reconciliation and sign off on the Batch Reconciliation Approval Form (Annexure-5).
4. Ensure that all batch reconciliation records are stored according to the company’s document retention policy.

5.6. Documentation and Record-Keeping

1. Ensure that all batch reconciliation records, including the Batch Production Record (BPR), Deviation Reports, CAPA logs, and Batch Reconciliation Approval Form, are properly documented and stored in accordance with the company’s record retention policy.
2. These records must be readily available for internal audits, regulatory inspections, and product traceability.

6. Abbreviations

• GMP: Good Manufacturing Practice
• QC: Quality Control
• CAPA: Corrective and Preventive Actions
• PPE: Personal Protective Equipment
• SOP: Standard Operating Procedure

7. Documents

1. Batch Production Record (BPR) (Annexure-1)
2. Deviation Report (Annexure-2)
3. Corrective and Preventive Action (CAPA) Log (Annexure-3)
4. Batch Reconciliation Approval Form (Annexure-4)
5. Batch 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 Production Record (BPR)

Batch No.	Raw Materials Used	Product Yield	Packaging Materials	Waste/By-Product
12345	Material A, Material B	5000 units	Label A, Box A	50 units

Annexure-2: Deviation Report

Batch No.	Deviation Description	Corrective Action	Operator Name
12345	Excess raw material consumption	Adjust raw material handling procedures	Rajesh Patel

Annexure-3: CAPA Log

Batch No.	Corrective Action	Preventive Action	Completion Date	Responsible Person
12345	Retrained operators on material handling	Updated material handling SOPs	06/02/2025	Rajesh Patel

Annexure-4: Batch Reconciliation Approval Form

Batch No.	Approved By	Approval Date	Remarks
12345	Anjali Sharma	06/02/2025	No discrepancies

Annexure-5: Batch Reconciliation Log

Batch No.	Reconciliation Date	Operator Name	Discrepancies	Corrective Actions
12345	06/02/2025	Rajesh Patel	No discrepancies	None

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