Standard Operating Procedure for Material Dispensing and Reconciliation in QA

Department	Tablet
SOP No.	SOP/TAB/197/2025
Supersedes	SOP/TAB/197/2022
Page No.	Page 1 of 6
Issue Date	01/03/2026
Effective Date	06/03/2026
Review Date	01/03/2027

1. Purpose

To establish the procedure for dispensing raw materials for tablet production and reconciling the materials used with the quantities recorded, ensuring accuracy and compliance with GMP guidelines.

2. Scope

This SOP applies to all tablet production runs within the facility. It covers the dispensing of raw materials for manufacturing, the reconciliation of dispensed amounts, and the documentation of all activities to ensure material traceability and accountability.

3. Responsibilities

• Quality Assurance (QA): Responsible for overseeing the dispensing and reconciliation process, ensuring that all records are accurate and compliant with GMP requirements.
• Production Team: Responsible for following the dispensing instructions and ensuring accurate measurements of raw materials.
• Warehouse Team: Responsible for providing the required raw materials and ensuring that materials are labeled correctly for easy identification.
• Inventory Control: Responsible for tracking the quantities of raw materials dispensed and used during production and ensuring that discrepancies are addressed.

4. Accountability

The QA Manager is accountable for ensuring compliance with this SOP during the dispensing and reconciliation process. The Production Manager is responsible for the accurate dispensing of materials and the reconciliation process during tablet manufacturing.

5. Procedure

5.1 Material Dispensing

1. Before dispensing, ensure that the correct batch records are available and that the materials to be dispensed are approved for use in tablet production (Annexure-1).
2. Ensure that materials are dispensed in the specified quantities as per the batch formula and approved production documentation.
3. For each raw material, verify the correct identification, including lot number and expiry date, to ensure the material is eligible for use in production.
4. Use calibrated dispensing equipment to ensure accurate measurement of raw materials (e.g., balances, volumetric devices).
5. Once dispensed, materials should be labeled with relevant information, such as batch number, quantity, and the operator’s details (Annexure-2).

5.2 Reconciliation of Dispensed Materials

1. After the dispensing process, the quantity of materials dispensed should be recorded in the batch record and compared with the required quantities specified in the batch formula.
2. Verify that the total quantity of raw materials dispensed matches the batch requirements. Any discrepancies should be noted and investigated.
3. If any material is leftover after the production run, ensure that it is returned to inventory, properly labeled, and recorded in the material reconciliation log (Annexure-3).
4. Discrepancies in dispensing quantities should be immediately reported to the QA Manager for investigation. The cause of the discrepancy should be identified, and corrective actions should be implemented.

5.3 Documentation and Record Keeping

1. Ensure that all dispensing and reconciliation activities are thoroughly documented in the batch record and material reconciliation log (Annexure-4).
2. Ensure that all records include information such as raw material identification, lot numbers, quantities dispensed, the operator’s name, and any adjustments made.
3. All records should be reviewed for accuracy by the QA team before batch approval.
4. Ensure that all records are filed and stored for the required retention period as per regulatory guidelines, typically for five years or as specified by local regulations.

5.4 Handling of Leftover Materials

1. If any material remains unused after the production process, it should be returned to the inventory with proper documentation, including the reason for its return.
2. The returned material should be checked to ensure that it meets all necessary quality specifications before being re-allocated for future use.
3. Ensure that the unused material is properly segregated and stored to prevent cross-contamination with other materials (Annexure-5).

5.5 Review and Verification

1. At the end of the production run, the dispensing and reconciliation records should be reviewed for accuracy by the QA team to ensure compliance with SOPs.
2. If any discrepancies or deviations are found during the review, initiate corrective actions and document them in the CAPA system (Annexure-6).
3. Upon successful review, approve the batch for further processing or packaging, ensuring that all materials are accounted for correctly.

5.6 Corrective Actions

1. If any discrepancies or deviations are identified during the reconciliation process, take immediate corrective action to identify the cause of the discrepancy and prevent recurrence.
2. Document the corrective actions taken and track their effectiveness in resolving the issue.

6. Abbreviations

• SOP: Standard Operating Procedure
• QA: Quality Assurance
• GMP: Good Manufacturing Practice
• CAPA: Corrective and Preventive Action
• API: Active Pharmaceutical Ingredient

7. Documents

1. Material Dispensing Log (Annexure-1)
2. Dispensed Material Identification and Labeling Log (Annexure-2)
3. Material Reconciliation Log (Annexure-3)
4. Returned Materials Record (Annexure-4)
5. Corrective Action Report (Annexure-5)
6. CAPA Log (Annexure-6)

8. References

• 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals (US FDA)
• ISO 9001 – Quality Management Systems
• ICH Q7 – Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients

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 Dispensing Log

Material Name	Batch Number	Quantity Dispensed	Operator	Date
Material A	Batch-12345	500 kg	John Doe	01/03/2026

Annexure-2: Dispensed Material Identification and Labeling Log

Material Name	Batch Number	Label Applied	Operator	Labeling Date
Material A	Batch-12345	Label 001	Jane Smith	01/03/2026

Annexure-3: Material Reconciliation Log

Material Name	Quantity Dispensed	Quantity Used	Quantity Returned	Remaining Quantity
Material A	500 kg	450 kg	50 kg	0 kg

Annexure-4: Returned Materials Record

Material Name	Batch Number	Returned Quantity	Reason for Return	Returned By
Material A	Batch-12345	50 kg	Excess Dispensed	John Doe

Annexure-5: Corrective Action Report

Action ID	Issue	Corrective Action	Completion Date
CAPA-001	Dispensing error	Retrained dispensing team	01/04/2026

Annexure-6: CAPA Log

Action ID	Action Description	Responsible Person	Completion Date
CAPA-001	Dispensing error investigation and training	Jane Smith	01/05/2026

Revision History:

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
01/01/2024	1.0	Initial Version	New SOP Creation	QA Head
01/02/2025	2.0	Clarification of material reconciliation process	Improved procedures	QA Head