Standard Operating Procedure for Reconciliation of Issued and Returned Materials in API Manufacturing
| Department | API Manufacturing |
|---|---|
| SOP No. | SOP/API/009/2025 |
| Supersedes | SOP/API/009/2022 |
| Page No. | Page 1 of 10 |
| Issue Date | 13/04/2025 |
| Effective Date | 15/04/2025 |
| Review Date | 13/04/2026 |
1. Purpose
To describe the systematic procedure for reconciling the quantity of raw materials issued to production and the quantity of unused materials returned to the warehouse, ensuring material accountability, inventory accuracy, and GMP compliance.
2. Scope
This SOP applies to all raw materials issued and returned during the manufacturing of API batches in the facility. It is applicable to warehouse, production, and quality assurance departments.
3. Responsibilities
- Production Supervisor: Monitor usage, return excess materials, and complete reconciliation sheet.
- Warehouse Staff: Verify returned materials, update stock, and document reconciliation.
- QA Officer: Review reconciliation records, authorize return, and investigate discrepancies.
4. Accountability
The Warehouse Manager is accountable for ensuring that all material reconciliations are performed accurately and documented properly. QA Manager ensures procedural compliance.
5. Procedure
5.1 Reconciliation Initiation
- Reconciliation begins immediately after batch completion or at the end of each shift.
- Production shall complete the “Material Usage and Return Form” (Annexure-1) with details of:
- Issued Quantity
- Consumed Quantity
- Returned Quantity
- Losses (spillage, dusting, evaporation)
5.2 Return of Unused Materials
- Ensure returned materials:
- Are in their original labeled containers
- Are securely sealed
- Show no signs of contamination or tampering
- Label returned material with a “Returned from Production” tag (yellow) indicating:
- Batch No.
- Date of Return
- Qty Returned
- Returned By
- Warehouse staff logs the return in the “Returned Material Register” (Annexure-2).
5.3 Verification by Warehouse and QA
- Warehouse Executive verifies returned quantity against issued amount.
- QA checks the physical condition of returned containers and cross-verifies against reconciliation form.
- Any deviations > ±2% must be documented as a “Material Reconciliation Deviation” (Annexure-3) and investigated.
5.4 Final Reconciliation and Stock Update
- Reconcile total material used as per formula:
Issued Quantity = Consumed Quantity + Returned Quantity + Documented Losses
- On successful reconciliation:
- Update ERP/Inventory System
- Stock returned material to the appropriate “Returned Material Area” for future use
- In case of repeated excess losses or untraceable materials, escalate for root cause analysis and CAPA.
6. Abbreviations
- SOP: Standard Operating Procedure
- QA: Quality Assurance
- ERP: Enterprise Resource Planning
- CAPA: Corrective and Preventive Action
7. Documents
- Material Usage and Return Form (Annexure-1)
- Returned Material Register (Annexure-2)
- Material Reconciliation Deviation Form (Annexure-3)
8. References
- ICH Q7 – GMP Guidelines for Active Pharmaceutical Ingredients
- 21 CFR Part 211.184 – Component inventory control
- WHO TRS 986 Annex 2 – Material control practices
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | Rajesh Kumar | Sunita Reddy | Manoj Verma |
| Designation | Warehouse Executive | QA Executive | QA Manager |
| Department | API Manufacturing | Quality Assurance | Quality Assurance |
11. Annexures
Annexure-1: Material Usage and Return Form
| Date | Material | Batch | Issued Qty | Consumed Qty | Returned Qty | Loss | Returned By |
|---|---|---|---|---|---|---|---|
| 13/04/2025 | Solvent A | SA202504 | 100 kg | 97 kg | 2 kg | 1 kg | Vikas Sharma |
Annexure-2: Returned Material Register
| Date | Material | Batch | Qty | Condition | Verified By |
|---|---|---|---|---|---|
| 13/04/2025 | Solvent A | SA202504 | 2 kg | Good | Rajesh Kumar |
Annexure-3: Material Reconciliation Deviation Form
| Date | Material | Batch | Deviation | Investigation Summary | QA Review |
|---|---|---|---|---|---|
| 13/04/2025 | Solvent A | SA202504 | 3% Loss | Observed minor spillage | Acceptable |
Revision History:
| Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By |
|---|---|---|---|---|
| 01/01/2022 | 1.0 | Initial SOP | Process Documentation | QA Head |
| 13/04/2025 | 2.0 | Included Loss Analysis and ERP Integration | GMP Enhancement | QA Head |