Standard Operating Procedure for Dispensing of Sweeteners in Elixir Manufacturing
| Department | Elixir Department |
|---|---|
| SOP No. | SOP/ELX/048/2025 |
| Supersedes | SOP/ELX/048/2022 |
| Page No. | Page 1 of 8 |
| Issue Date | 11/04/2025 |
| Effective Date | 15/04/2025 |
| Review Date | 11/04/2026 |
1. Purpose
To define the standard procedure for dispensing sweeteners used in the formulation of oral elixirs, ensuring accuracy, product consistency, and GMP compliance.
2. Scope
This SOP is applicable to the dispensing of both natural and artificial sweeteners such as sucrose, sorbitol, aspartame, saccharin sodium, and sucralose used in the Elixir Department.
3. Responsibilities
- Dispensing Operator:
- Dispense sweeteners as per batch requirement under controlled conditions.
- Ensure accurate weighing and proper labeling of containers.
- Supervisor:
- Verify identity and quantity of the dispensed sweetener.
- QA Officer:
- Ensure that all records are complete and materials are dispensed under suitable conditions.
4. Accountability
The Production Head is accountable for ensuring the correct dispensing of sweeteners and maintaining batch traceability and accuracy.
5. Procedure
5.1 Material Verification
- Check the Material Requisition Form (MRF) and Batch Manufacturing Record (BMR) for
the exact sweetener type and quantity.
Ensure the material is approved by QA and within expiry.
Inspect the container label for:
- Material Name
- Batch Number
- Manufacturer
- Expiry Date
5.2 Dispensing Preparation
- Transfer the container to the dispensing booth or designated area.
- Clean the outer surface of the container with 70% IPA before opening.
- Wear PPE and ensure weighing balance is calibrated and tared properly.
5.3 Dispensing Activity
- Use a clean, dry scoop or spatula for solid sweeteners and graduated cylinder or syringe for liquid sweeteners.
- Weigh the required quantity as per BMR and transfer it into a clean labeled container.
- Label the dispensed material with:
- Sweetener Name
- Batch Number
- Quantity Dispensed
- Date
- Container Number
5.4 Documentation
- Enter details in the Material Dispensing Log (Annexure-1) and BMR.
- Obtain verification signatures from the supervisor for the dispensed quantity and label content.
5.5 Handling of Unused Material
- Seal the original container tightly and label it as “Partially Used.”
- Return the material to the warehouse with a Material Return Slip and update inventory records accordingly.
6. Abbreviations
- BMR: Batch Manufacturing Record
- MRF: Material Requisition Form
- QA: Quality Assurance
- SOP: Standard Operating Procedure
7. Documents
- Material Dispensing Log (Annexure-1)
- Certificate of Analysis (Annexure-2)
- Material Return Slip (Annexure-3)
8. References
- 21 CFR Part 211 – Good Manufacturing Practice
- WHO GMP – Annex 4: Manufacture of Liquid Dosage Forms
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 Dispensing Log
| Date | Sweetener | Batch No. | Quantity | Dispensed By | Verified By |
|---|---|---|---|---|---|
| 11/04/2025 | Aspartame | AS9981 | 0.300 kg | Rajesh Kumar | Sunita Reddy |
Annexure-2: Certificate of Analysis
| Sweetener | Batch No. | Assay | Result | Status |
|---|---|---|---|---|
| Aspartame | AS9981 | 98.0%–102.0% | 99.3% | Complies |
Annexure-3: Material Return Slip
| Date | Sweetener | Batch No. | Qty Returned | Returned By | Warehouse Received By |
|---|---|---|---|---|---|
| 11/04/2025 | Aspartame | AS9981 | 0.200 kg | Rajesh Kumar | Deepak Sharma |
Revision History:
| Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By |
|---|---|---|---|---|
| 01/01/2024 | 1.0 | Initial Release | New SOP Creation | QA Head |
| 11/04/2025 | 2.0 | Enhanced Procedure and Added Annexures | GMP Alignment | QA Head |