Standard Operating Procedure for Issuance of Raw Materials to Production in API Manufacturing
| Department | API Manufacturing |
|---|---|
| SOP No. | SOP/API/007/2025 |
| Supersedes | SOP/API/007/2022 |
| Page No. | Page 1 of 10 |
| Issue Date | 13/04/2025 |
| Effective Date | 15/04/2025 |
| Review Date | 13/04/2026 |
1. Purpose
To define the standardized procedure for the controlled issuance of raw materials from warehouse to production area for manufacturing of Active Pharmaceutical Ingredients (API), ensuring traceability, GMP compliance, and prevention of cross-contamination or mix-ups.
2. Scope
This SOP applies to all warehouse and production personnel responsible for the material requisition, verification, dispensing, labeling, and handover of raw materials to the production team in the API manufacturing facility.
3. Responsibilities
- Production Supervisor: Raise material requisition and verify materials at receiving point.
- Warehouse Staff: Identify, pick, weigh/dispense, and issue materials as per request.
- QA Officer: Verify issuance activities and perform line clearance when required.
4. Accountability
The Warehouse Manager is accountable for ensuring the issuance process is documented, compliant with GMP, and supports traceability from storage to production.
5. Procedure
5.1 Material Requisition
- Production department raises a “Material Requisition Slip” (Annexure-1) authorized by the Production Head.
- The slip must contain:
- Product Name
- Batch Number
- Material Name
- Required Quantity
- Requisition Date
5.2 Verification and Picking
- Warehouse personnel review the requisition form and locate the approved material stock in the released area.
- Verify:
- Material Name
- Batch Number
- Label Details
- Approval Tag
- Expiry Date
- Record the batch selected and crosscheck with the FEFO/FIFO system before picking.
5.3 Dispensing and Labeling
- Transfer the material to the dispensing area under LAF (if required by material category).
- Weigh the required quantity using a calibrated balance.
- Record weight, date, container number, and initials in the “Material Issuance Log” (Annexure-2).
- Label each dispensed container with:
- Material Name
- Issued Quantity
- Batch No.
- Issued To
- Issued By
- Date & Time
5.4 Material Handover and Line Clearance
- After labeling, warehouse personnel transfer the issued material to the production staging area.
- Production supervisor verifies the materials against the requisition slip.
- QA performs line clearance and ensures:
- No damage or mix-up
- Cleanliness of containers
- Label confirmation
- QA signs off the “Material Transfer Verification Form” (Annexure-3).
5.5 Reconciliation and Documentation
- Any excess or short material issued must be documented and justified.
- Returned materials (if any) must be clearly labeled as “Returned from Production” and stored separately.
- Reconciliation must be signed by both Warehouse and Production Heads.
6. Abbreviations
- SOP: Standard Operating Procedure
- QA: Quality Assurance
- LAF: Laminar Airflow
- FEFO: First Expiry, First Out
- FIFO: First In, First Out
7. Documents
- Material Requisition Slip (Annexure-1)
- Material Issuance Log (Annexure-2)
- Material Transfer Verification Form (Annexure-3)
8. References
- ICH Q7: GMP Guide for APIs
- 21 CFR Part 211.101 – Written Procedures; Deviations
- WHO TRS 986 Annex 2
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 Officer | QA Manager |
| Department | API Manufacturing | Quality Assurance | Quality Assurance |
11. Annexures
Annexure-1: Material Requisition Slip
| Date | Product Name | Batch No. | Material | Quantity | Requested By |
|---|---|---|---|---|---|
| 13/04/2025 | API-A | BA202504 | Solvent X | 100 L | Vikas Sharma |
Annexure-2: Material Issuance Log
| Date | Material | Batch | Issued Qty | Issued To | Issued By |
|---|---|---|---|---|---|
| 13/04/2025 | Solvent X | SX202504 | 100 L | Production | Rajesh Kumar |
Annexure-3: Material Transfer Verification Form
| Date | Material | Batch | Verified By (Prod) | Verified By (QA) |
|---|---|---|---|---|
| 13/04/2025 | Solvent X | SX202504 | Vikas Sharma | Sunita Reddy |
Revision History:
| Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By |
|---|---|---|---|---|
| 01/01/2022 | 1.0 | Initial SOP | GMP Compliance | QA Head |
| 13/04/2025 | 2.0 | Added FEFO and Line Clearance Details | Audit Observation | QA Head |