SOP, and approving any deviations or discrepancies that arise during production.

Warehouse Team: Responsible for tracking and issuing the correct quantities of raw materials and packaging materials to the production team and maintaining accurate records of materials issued and returned.

4. Accountability

The Production Manager is accountable for ensuring that batch reconciliation is performed accurately during production. The QC Manager is responsible for verifying the reconciliation data and ensuring it meets product specifications. The QA Manager is responsible for approving any discrepancies and ensuring compliance with regulatory requirements.

5. Procedure

5.1 Pre-Production Setup

1. Ensure that all raw materials, ingredients, and packaging materials are properly identified and available for the production run. Verify that the required quantities of each material are ready for use as per the Batch Manufacturing Record (BMR).
2. Review the BMR to confirm the required quantities of raw materials, ingredients, and packaging materials for the batch, including any allowances for wastage or loss during the process.
3. Ensure that the Warehouse Team has issued the correct quantities of materials, and document the issuance in the Raw Material Issuance Log (Annexure-1).

5.2 In-Process Batch Reconciliation

1. During production, the Production Team must record the quantities of raw materials and ingredients used at regular intervals, as specified in the BMR.
2. Ensure that all ingredients are accurately measured and added according to the specified formulation, and document the measurements in the Ingredient Usage Log (Annexure-2).
3. If any materials are added outside of the approved amounts or if there are deviations from the BMR, report the discrepancies immediately to the QC team for review.
4. After the production process is complete, compare the amounts of raw materials and ingredients used with the quantities recorded in the BMR to verify that the reconciliation is accurate.

5.3 Verifying Batch Reconciliation

1. The QC team will verify the batch reconciliation by reviewing the following documents:
   • Batch Manufacturing Record (BMR)
   • Ingredient Usage Log (Annexure-2)
   • Raw Material Issuance Log (Annexure-1)
   • Material Returns Log (if applicable)
2. Ensure that the quantities of raw materials and ingredients used match the amounts specified in the BMR. Any discrepancies must be documented and investigated immediately.
3. Ensure that the total quantity of material returned (if any) is accurately recorded in the Material Returns Log, and verify that this material is properly stored or disposed of.
4. After reviewing all the records, approve the batch for the next stage (e.g., packaging or further processing) if the reconciliation is correct and no discrepancies are found.

5.4 Handling Discrepancies

1. If discrepancies are identified during the reconciliation process (e.g., material usage exceeding expected quantities, missing materials, etc.), stop production immediately and investigate the cause of the discrepancy.
2. Check the production records, including the BMR and ingredient usage logs, for any data entry errors or miscalculations.
3. Investigate the root cause of the discrepancy, which could include incorrect material measurements, equipment malfunction, or human error.
4. Document the discrepancy and the corrective actions taken in the Deviation Report (Annexure-3). Ensure that the report is reviewed and signed by the QA team before production is resumed.

5.5 Post-Production Activities

1. Once the batch has been reconciled and approved, prepare all reconciliation documents for final review and storage. These include the Batch Manufacturing Record, Ingredient Usage Log, and Material Returns Log.
2. Ensure that all reconciliation records are filed and stored for future reference and auditing purposes. These records must be maintained for at least two years or as per regulatory guidelines.
3. If the batch is verified to be accurate, proceed to the next stage in production, such as packaging and labeling. If discrepancies are found, take corrective actions and revalidate the batch before moving forward.

5.6 Documentation and Record-Keeping

1. Ensure that all batch reconciliation records are completed accurately and fully, including material usage, discrepancies, and corrective actions.
2. Maintain a record of all materials issued, used, and returned, as well as any deviations, in the Material Issuance Log, Ingredient Usage Log, and Material Returns Log.
3. Ensure that all documents are reviewed for completeness and accuracy by the QC team, and that they are signed off by the appropriate personnel.
4. Store all records for a minimum of two years or as per regulatory requirements, and ensure that they are readily available for audits or inspections.

6. Abbreviations

• GMP: Good Manufacturing Practices
• QC: Quality Control
• QA: Quality Assurance
• BMR: Batch Manufacturing Record
• PPE: Personal Protective Equipment

7. Documents

1. Annexure-1: Raw Material Issuance Log
2. Annexure-2: Ingredient Usage Log
3. Annexure-3: Deviation Report

8. References

• Good Manufacturing Practices (GMP) Guidelines – 21 CFR Part 211
• International Conference on Harmonisation (ICH) Q7 – Good Manufacturing Practice for Active Pharmaceutical Ingredients
• FDA Guidance for Industry: Batch Reconciliation in Pharmaceutical Manufacturing

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Raw Material Issuance Log

Material Name	Quantity Issued	Batch Number	Issued By	Issue Date
Raw Material A	100 kg	12345	John Doe	21/01/2026

Annexure-2: Ingredient Usage Log

Ingredient Name	Quantity Used	Batch Number	Operator	Time
Ingredient A	50 kg	12345	Jane Smith	09:30 AM

Annexure-3: Deviation Report

Batch Number	Deviation Description	Corrective Action	Resolved By
12345	Excessive raw material usage	Adjusted batch quantities, recalculated BMR	QA Head

Revision History:

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
01/03/2024	1.0	Initial Version	New SOP Creation	QA Head
01/03/2025	2.0	Format Revision and Updates	Standardization of Document	QA Head