QA Manager is accountable for ensuring that the material reconciliation process is followed accurately, that discrepancies are resolved promptly, and that accurate records are maintained throughout the production process.

5. Procedure

5.1 Material Issuance

1. Ensure that all materials required for production are issued according to the material requisition form.
2. Verify the quantities of raw materials, APIs, excipients, and packaging materials against the requisition list and update the inventory system accordingly.
3. Record the issued material details, including batch numbers, quantities, and any other relevant data in the material usage log (Annexure-1).
4. Ensure that materials are issued in accordance with the production schedule and that any changes are properly documented.

5.2 Material Usage Monitoring

1. During tablet manufacturing, monitor and record the actual quantities of materials used in the production process.
2. Note any wastage or rework materials generated during the process, and document the reasons for these discrepancies (e.g., process loss, machine issues) (Annexure-2).
3. Ensure that wastage is within acceptable limits, and if it exceeds the defined threshold, investigate the cause and take corrective actions.

5.3 Material Reconciliation

1. After each production batch is completed, perform a reconciliation of the materials used with the original quantities issued.
2. Compare the quantities of raw materials used, wastage, and final tablet production against the quantities issued and update the inventory accordingly.
3. Calculate the material yield, which should account for all usage, wastage, and final product yield. Any significant discrepancies must be investigated (Annexure-3).
4. If there are discrepancies between the quantities issued and the quantities used, notify QA and investigate the potential causes, including issues such as measurement errors, incorrect material issues, or process inefficiencies.

5.4 Discrepancy Investigation

1. If discrepancies in material usage or wastage are identified, conduct an investigation to determine the root cause.
2. Review all material handling, storage, and manufacturing records to identify potential areas for improvement.
3. Investigate any discrepancies in the issuance process, including whether the correct quantities were issued or if there was an error in the material receipt process (Annexure-4).
4. Investigate any potential operational issues, such as incorrect weighing or measuring of materials, process losses, or equipment malfunctions.
5. Corrective actions should be taken to address the root cause of any discrepancies and prevent recurrence.

5.5 Documentation and Record Keeping

1. Maintain accurate records of material usage, wastage, and reconciliation for each production batch (Annexure-1, Annexure-2, Annexure-3, and Annexure-4).
2. Ensure all records are signed and dated by the responsible personnel to confirm the accuracy of the information.
3. Store all material reconciliation records securely and retain them for at least five years or as required by regulatory guidelines.

5.6 Reporting

1. Report material discrepancies and corrective actions taken to senior management for review and decision-making.
2. Provide quarterly reports on material reconciliation and any corrective actions taken to ensure ongoing compliance with material management procedures.

6. Abbreviations

• SOP: Standard Operating Procedure
• QA: Quality Assurance
• QC: Quality Control
• RPN: Risk Priority Number
• CAPA: Corrective and Preventive Action

7. Documents

1. Material Usage Log (Annexure-1)
2. Material Wastage Log (Annexure-2)
3. Material Reconciliation Report (Annexure-3)
4. Discrepancy Investigation Report (Annexure-4)

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 Usage Log

Batch Number	Material Name	Quantity Issued	Quantity Used	Wastage
Batch-12345	API-123	1000 kg	980 kg	20 kg

Annexure-2: Material Wastage Log

Batch Number	Material Name	Wastage Reason	Wastage Quantity
Batch-12345	API-123	Process Loss	20 kg

Annexure-3: Material Reconciliation Report

Batch Number	Material Name	Issued Quantity	Used Quantity	Reconciliation Status
Batch-12345	API-123	1000 kg	980 kg	Reconciled

Annexure-4: Discrepancy Investigation Report

Batch Number	Discrepancy Description	Investigation Findings	Corrective Actions	Completion Date
Batch-12345	Discrepancy in material usage	Measurement error during production	Re-calibrated equipment and retrained personnel	15/04/2026

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	Updated material reconciliation process	Improved tracking and reporting of discrepancies	QA Head