Standard Operating Procedure for Reconciliation of Raw Materials Post Dispensing

Department	Elixir Department
SOP No.	SOP/ELX/015/2025
Supersedes	SOP/ELX/015/2022
Page No.	Page 1 of 8
Issue Date	13/04/2025
Effective Date	15/04/2025
Review Date	13/04/2026

1. Purpose

To define a standardized procedure for reconciling raw materials after dispensing, ensuring accountability, traceability, and compliance with cGMP to avoid mix-ups, losses, or misappropriation of raw materials in elixir manufacturing.

2. Scope

This SOP applies to all raw materials including active ingredients, excipients, solvents, and additives dispensed for elixir production in the Elixir Department and covers reconciliation immediately following completion of the dispensing activity.

3. Responsibilities

• Dispensing Operator:
  • Weigh and record quantities dispensed and remaining.
  • Label leftover material containers and segregate for return or rejection.
• Warehouse Supervisor:
  • Verify reconciliation data and ensure documentation accuracy.
• QA Officer:
  • Cross-check reconciliation figures and approve material return or destruction.

4. Accountability

The Head of Warehouse and Head of QA are accountable for ensuring all raw materials are properly reconciled, recorded, and verified post dispensing.

5. Procedure

5.1 Completion of Dispensing Activity

1. Once dispensing for a batch is complete, record the exact quantity of each material dispensed into the Batch Manufacturing Record (BMR).
2. Label all partially used containers with:
   • “Partially Used” tag
   • Material name and code
   • Remaining quantity
   • Batch number
   • Date

5.2 Material Reconciliation

1. Compare the following parameters for each material used:
   • Issued Quantity
   • Quantity Dispensed
   • Remaining Quantity
   • Quantity Rejected (if any)
2. Ensure total matches the originally issued quantity.
3. Record all details in the Material Reconciliation Sheet (Annexure-1).

5.3 Verification and Approval

1. Warehouse Supervisor reviews entries and physically verifies balances.
2. QA performs independent verification by matching:
   • Dispensed logs
   • Label quantities
   • BMR entries
3. Sign the reconciliation sheet and approve the movement of leftover materials.

5.4 Handling Leftover Materials

1. If leftover material is clean, properly labeled, and within expiry:
   • Return to approved storage location under “Partially Used” status.
2. If material is suspected to be contaminated, expired, or damaged:
   • Segregate and label as “REJECTED.”
   • Record in Rejected Material Log.

5.5 Handling Discrepancies

1. In case of material shortfall or excess:
   • Document deviation in the Deviation Form.
   • Investigate root cause and implement corrective actions.

6. Abbreviations

• SOP: Standard Operating Procedure
• BMR: Batch Manufacturing Record
• QA: Quality Assurance
• cGMP: Current Good Manufacturing Practice

7. Documents

1. Material Reconciliation Sheet (Annexure-1)
2. Rejected Material Log (if applicable)
3. Deviation Report (if applicable)

8. References

• 21 CFR Part 211 – Subpart E: Control of Components
• WHO GMP – Materials Management 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 Sheet

Material Name	Batch No.	Issued Qty (kg)	Dispensed Qty (kg)	Returned Qty (kg)	Rejected Qty (kg)	Remarks
Sorbitol	SB0425A	25	23	2	0	Reconciled

Revision History:

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
10/01/2022	1.0	Initial Version	New SOP	QA Head
13/04/2025	2.0	Included deviation and discrepancy handling section	Audit Observation	QA Head