Standard Operating Procedure for Documentation of Dispensed Quantities
| Department | Sterile Injectable Manufacturing |
|---|---|
| SOP No. | SOP/SIM/109/2025 |
| Supersedes | SOP/SIM/109/2022 |
| Page No. | Page 1 of 10 |
| Issue Date | 18/06/2025 |
| Effective Date | 20/06/2025 |
| Review Date | 18/06/2026 |
1. Purpose
To define the procedure for documenting the quantities of raw materials dispensed for each batch in sterile injectable manufacturing, ensuring traceability and compliance with cGMP requirements.
2. Scope
This procedure is applicable to all raw materials (APIs and excipients) dispensed in the dispensing area for batch manufacturing of
sterile injectable products.
3. Responsibilities
- Dispensing Operator: Record dispensed quantities, weights, date, and time in real-time on the dispensing sheet.
- Production Supervisor: Review dispensing documentation before releasing materials to manufacturing.
- QA Personnel: Verify and approve all records and ensure compliance with the documentation SOP.
4. Accountability
The Head of Production and Head of QA are accountable for ensuring adherence to this SOP.
5. Procedure
5.1 Documentation in Dispensing Sheets
- Each material dispensed must be documented in the Dispensing Sheet (Annexure-1) with the following information:
- Material Name and Code
- Batch Number of Raw Material
- Required Quantity
- Actual Dispensed Quantity
- Container Number and Seal Status
- Date, Time, Signature of Dispensing Operator
- All weights must be recorded to the appropriate decimal precision as per weighing balance specifications.
5.2 Correction of Entries
- Do not overwrite. Use a single strike-through and initial any correction.
- Mention reason for correction if the deviation is significant (e.g., difference >1%).
5.3 Verification and Archiving
- QA verifies and signs off the documentation against the approved BMR.
- Completed dispensing records are filed with the batch manufacturing record (BMR).
- Electronic records, if used, must be backed up and protected by password-controlled access.
6. Abbreviations
- API: Active Pharmaceutical Ingredient
- BMR: Batch Manufacturing Record
- cGMP: current Good Manufacturing Practices
- QA: Quality Assurance
7. Documents
- Dispensing Sheet – Annexure-1
- Dispensing Logbook – Annexure-2
- Material Usage Summary – Annexure-3
8. References
- 21 CFR Part 211 – cGMP for Finished Pharmaceuticals
- Company Quality System Manual
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | Dispensing Executive | QA Executive | Head QA |
| Department | Production | Quality Assurance | Quality Assurance |
11. Annexures
Annexure-1: Dispensing Sheet
| Material Name | Batch No. | Qty Required | Qty Dispensed | Container No. | Date | Operator |
|---|---|---|---|---|---|---|
| Sodium Chloride | SC2201 | 10.00 kg | 10.05 kg | 1 | 18/06/2025 | R. Verma |
Annexure-2: Dispensing Logbook
Chronological record of all dispensing activities per day per shift with signatures.
Annexure-3: Material Usage Summary
Summary of materials dispensed, used, returned, and reconciled for the batch.
Revision History
| Revision Date | Revision No. | Details | Reason | Approved By |
|---|---|---|---|---|
| 10/01/2022 | 1.0 | Initial version | New SOP implementation | QA Head |
| 18/06/2025 | 2.0 | Expanded documentation requirements and digital record inclusion | GMP Update | QA Head |