Standard Operating Procedure for Dispensing Active Ingredients in Elixir Production
| Department | Elixir Department |
|---|---|
| SOP No. | SOP/ELX/027/2025 |
| Supersedes | SOP/ELX/027/2022 |
| Page No. | Page 1 of 8 |
| Issue Date | 11/04/2025 |
| Effective Date | 15/04/2025 |
| Review Date | 11/04/2026 |
1. Purpose
The purpose of this SOP is to define a standardized method for the accurate, safe, and contamination-free dispensing of active pharmaceutical ingredients (APIs) used in elixir formulations. This ensures compliance with cGMP and maintains the integrity and traceability of dispensed materials.
2. Scope
This SOP is applicable to all authorized production and warehouse personnel involved in the dispensing of APIs intended for elixir manufacturing within the Elixir Department. It covers materials approved by Quality Control (QC) and includes all activities from requisition to documentation.
3. Responsibilities
- Warehouse Staff:
- Retrieve approved APIs and verify details before dispensing.
- Ensure cleanliness and readiness of the dispensing area.
- Production Pharmacist:
- Supervise the dispensing activity and verify the correct quantity and label.
- QA Personnel:
- Conduct in-process checks and authorize the release of dispensed material.
See also Elixir Department: SOP for Transfer of Materials to Quarantine Area Post Dispensing - V 2.0
4. Accountability
The Production Head of the Elixir Department is accountable for ensuring the implementation of this SOP and compliance with GMP requirements during the dispensing of APIs.
5. Procedure
5.1 Requisition and Preparation
- Verify the manufacturing batch record (MBR) to determine the quantity of API required.
- Generate a dispensing request and ensure approval by the Production Head.
- Confirm availability and release status of API in the inventory management system.
- Check cleanliness of dispensing equipment, weighing balances, containers, and PPE.
5.2 Verification and Weighing
- Retrieve the required API from the approved material storage area.
- Check and verify the following on the container label:
- Material Name
- Batch Number
- Expiry Date
- Storage Condition
- Bring the container to the dispensing booth. Ensure differential pressure is maintained.
- Calibrate the balance prior to use and record in the calibration log.
- Weigh the required quantity using a clean, labeled container. Record the actual quantity weighed.
5.3 Labeling and Transfer
- Affix a ‘Dispensed’ label with the following information:
- Name of Material
- Quantity Weighed
- Batch Number
- Weighed By
- Date
- Seal the container securely and transfer it to the staging area with appropriate documentation.
- Ensure transport trolley or containers are clean and dedicated to API transfer.
5.4 Documentation and Review
- Update the Material Dispensing Log (Annexure-1) with complete information.
- Attach the Certificate of Analysis (Annexure-2) for batch-specific quality confirmation.
- Fill out the Approval and Release Form (Annexure-3) and forward to QA for review.
- Retain copies of all records as part of the batch production file.
6. Abbreviations
- API: Active Pharmaceutical Ingredient
- QA: Quality Assurance
- QC: Quality Control
- MBR: Manufacturing Batch Record
- SOP: Standard Operating Procedure
7. Documents
- Material Dispensing Log (Annexure-1)
- Certificate of Analysis (Annexure-2)
- Approval and Release Form (Annexure-3)
8. References
- ICH Q7 – GMP for Active Pharmaceutical Ingredients
- WHO TRS 986 Annex 2 – GMP for Pharmaceutical Products
- 21 CFR Part 211 – Current Good Manufacturing Practice
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 | Material | Batch No. | Qty Weighed | Weighed By | Checked By |
|---|---|---|---|---|---|
| 11/04/2025 | Diphenhydramine HCl | DPH2201 | 1.5 kg | Rajesh Kumar | Sunita Reddy |
| 11/04/2025 | Paracetamol | PCT5544 | 3.0 kg | Ajay Mehta | Kiran Joshi |
Annexure-2: Certificate of Analysis (CoA)
| Material | Batch No. | Test | Result | Status |
|---|---|---|---|---|
| Diphenhydramine HCl | DPH2201 | Identification | Complies | Pass |
| Paracetamol | PCT5544 | Assay | 99.3% | Pass |
Annexure-3: Approval and Release Form
| Date | Material | Batch No. | Released By | Approved By | Remarks |
|---|---|---|---|---|---|
| 11/04/2025 | Diphenhydramine HCl | DPH2201 | Sunita Reddy | Manoj Verma | Approved for Batch #ELX1001 |
| 11/04/2025 | Paracetamol | PCT5544 | Ajay Mehta | Manoj Verma | Approved for Batch #ELX1002 |
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 | Format revision; alignment with updated GMP practices | Document standardization | QA Head |