Standard Operating Procedure for Batch Verification of Dispensed Materials
| Department | Sterile Injectable Manufacturing |
|---|---|
| SOP No. | SOP/SIM/107/2025 |
| Supersedes | SOP/SIM/107/2022 |
| Page No. | Page 1 of 12 |
| Issue Date | 18/06/2025 |
| Effective Date | 20/06/2025 |
| Review Date | 18/06/2026 |
1. Purpose
To define the procedure for batch-wise verification of dispensed raw materials prior to use in sterile injectable manufacturing, ensuring correct material identity, quantity, and traceability.
2. Scope
This procedure applies to all batches of raw materials dispensed and released for production of
sterile injectable products.
3. Responsibilities
- Dispensing Operator: Perform physical verification and record observations.
- Production Supervisor: Cross-verify dispensed material details with manufacturing order.
- QA Executive: Review and release batch for manufacturing after verification.
4. Accountability
The Head of Production is accountable for overall implementation and compliance.
5. Procedure
5.1 Material Batch Verification Steps
- Receive dispensed materials in the staging area with their labels, status tags, and dispensing records.
- Physically verify the following for each material:
- Material Name
- Material Code
- Batch/Lot Number
- Dispensed Quantity
- Status label (Approved, Quarantined, or Rejected)
- Match the above details with the Batch Manufacturing Record (BMR) and Dispensing Sheet (Annexure-1).
- Record discrepancies, if any, and notify QA immediately.
- Ensure reconciliation of issued vs required quantities.
5.2 Label Integrity
- Ensure all containers are properly labeled with legible and validated barcodes (if applicable).
- Cross-check the expiry date and retest date mentioned on labels.
5.3 QA Verification
- QA personnel shall review the entries and physical status of each dispensed item.
- Complete the Batch Verification Checklist (Annexure-2).
- QA signs the release approval on the Dispensing Sheet and BMR.
6. Abbreviations
- BMR: Batch Manufacturing Record
- QA: Quality Assurance
- SOP: Standard Operating Procedure
7. Documents
- Dispensing Sheet – Annexure-1
- Batch Verification Checklist – Annexure-2
- Dispensed Material Logbook – Annexure-3
8. References
- GMP Guidelines – WHO, EU Annex 1
- Company Quality Management Manual
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | Dispensing Officer | QA Executive | Head QA |
| Department | Production | Quality Assurance | Quality Assurance |
11. Annexures
Annexure-1: Dispensing Sheet
| Material | Batch No. | Code | Qty | Verified By |
|---|---|---|---|---|
| Mannitol | MN240621 | RM004 | 15.0 kg | S. Patil |
Annexure-2: Batch Verification Checklist
- Is material labeled correctly? □Yes □No
- Does batch number match? □Yes □No
- Is status label applied and accurate? □Yes □No
- Any discrepancy noted? □Yes □No (Details)
Annexure-3: Dispensed Material Logbook
Include: Date, Material Name, Code, Batch No., Quantity, Dispensed By, Verified By, Remarks
Revision History
| Revision Date | Revision No. | Details | Reason | Approved By |
|---|---|---|---|---|
| 20/02/2022 | 1.0 | Initial issue | New SOP | QA Head |
| 18/06/2025 | 2.0 | Checklist and reconciliation step added | Process Update | QA Head |