have been dispensed as per the batch record and formulation requirements.

Warehouse Personnel: Assists with providing materials, ensures proper storage, and helps with tracking the quantity of materials dispensed and returned.

Quality Assurance (QA): Reviews all reconciliation records to ensure compliance with GMP standards, approves the reconciliation of dispensed materials, and ensures corrective actions are taken in case of discrepancies.

4. Accountability

The Head of Creams Manufacturing is accountable for ensuring that the reconciliation process is followed for every batch. The QA Manager is responsible for overseeing the reconciliation process, reviewing the records, and ensuring compliance with this SOP.

5. Procedure

5.1 Pre-Reconciliation Preparation

1. Before starting the reconciliation process, verify that all materials for the batch have been dispensed and recorded in the Material Dispensing Log. Ensure that all weights, quantities, and batch numbers are accurate.
2. Review the formulation recipe and compare the dispensed quantities with the required quantities specified in the batch record to ensure that the correct amounts of each material have been used.
3. Any discrepancies between the required and dispensed quantities should be noted in the Material Dispensing Log, and any deviations must be reported to the QA team immediately for further investigation.

5.2 Reconciliation of Dispensed Quantities

1. QC personnel must perform the reconciliation of dispensed materials by verifying the quantities recorded in the Material Dispensing Log against the actual materials used in the formulation process. This includes checking each material’s batch number and quantity.
2. If any discrepancies are found, such as excess or insufficient quantities dispensed, the QC team must investigate the cause of the discrepancy. The discrepancy should be documented in the Material Reconciliation Report (Annexure-1), including the reason for the discrepancy and the corrective actions taken.
3. Once the reconciliation is complete, the quantities of dispensed materials must be updated in the inventory system to reflect the actual quantities used in production.

5.3 Handling of Discrepancies

1. If any discrepancies are identified during reconciliation (e.g., excess or insufficient quantities), the cause of the discrepancy must be determined. Possible causes may include miscalculation during dispensing, spillage, or incorrect recording.
2. For excess material dispensed, the material should be returned to its designated storage area, and the inventory records should be adjusted accordingly.
3. For insufficient material dispensed, the missing quantity should be dispensed and documented in the Material Dispensing Log. The discrepancy should be documented in the Material Reconciliation Report, and corrective actions should be taken to prevent future discrepancies.

5.4 Documentation of Reconciliation

1. All reconciliation activities must be documented in the Material Reconciliation Log, which should include the following information:
   • Material name and batch number
   • Quantity dispensed and quantity required
   • Reason for any discrepancies
   • Corrective actions taken
   • Date and time of reconciliation
   • Names of personnel involved in reconciliation
2. The Material Reconciliation Report (Annexure-1) must be signed by the personnel performing the reconciliation and reviewed by the QA team to ensure compliance with this SOP and GMP standards.
3. All reconciliation records should be filed and archived according to the company’s record retention policy, typically for a period of five years or as required by regulatory guidelines.

5.5 Review and Approval of Reconciliation

1. The QA team will review the reconciliation records to ensure that the materials used in the formulation are accounted for accurately. Any discrepancies must be addressed immediately, and corrective actions must be implemented to prevent recurrence.
2. The reconciliation records should be approved by the QA Manager, who will ensure that the records meet GMP standards and that corrective actions are effective.
3. Once the reconciliation is approved, the batch can proceed to the next stage in the production process, such as mixing or blending.

5.6 Corrective Actions for Discrepancies

1. If discrepancies are found during the reconciliation process, they must be investigated to identify the root cause. Common corrective actions include:
   • Re-calibrating dispensing equipment
   • Re-training production personnel on proper material dispensing techniques
   • Reviewing and updating dispensing procedures to minimize future errors
2. The corrective actions should be documented in the Corrective Action Log, and any necessary changes to procedures should be communicated to relevant personnel.

5.7 Final Review and Approval

1. Once all discrepancies have been resolved and the reconciliation process is complete, the QA team will conduct a final review of the reconciliation records. If the reconciliation is accurate and complete, the batch will be approved for further processing.
2. If the reconciliation process is not completed satisfactorily, the batch will be placed on hold until all discrepancies are resolved and the materials used are properly accounted for.

6. Abbreviations

• QC: Quality Control
• QA: Quality Assurance
• GMP: Good Manufacturing Practices

7. Documents

1. Material Reconciliation Log (Annexure-1)
2. Material Dispensing Log (Annexure-2)
3. Corrective Action Log (Annexure-3)

8. References

• Good Manufacturing Practices (GMP) Guidelines – 21 CFR Part 211
• International Conference on Harmonisation (ICH) Q7 – Good Manufacturing Practice for Active Pharmaceutical Ingredients
• Internal SOP for Material Dispensing and Reconciliation

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Material Reconciliation Log

Material Name	Batch Number	Quantity Dispensed	Quantity Required	Discrepancy	Corrective Action Taken	Verified By
Excipient A	12345	500g	500g	No	None	John Doe

Annexure-2: Material Dispensing Log

Material Name	Batch Number	Quantity Dispensed	Dispensed By	Time/Date
Excipient A	12345	500g	John Doe	05/04/2025

Annexure-3: Corrective Action Log

Deviation	Corrective Action Taken	Responsible Person	Completion Date
Incorrect Material Weight	Re-weighed material and re-dispensed	John Doe	05/04/2025

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