Standard Operating Procedure for Dispensing of Controlled Substances in Elixir Manufacturing
| Department | Elixir Department |
|---|---|
| SOP No. | SOP/ELX/030/2025 |
| Supersedes | SOP/ELX/030/2022 |
| Page No. | Page 1 of 9 |
| Issue Date | 11/04/2025 |
| Effective Date | 15/04/2025 |
| Review Date | 11/04/2026 |
1. Purpose
This SOP outlines the standardized procedure for secure, accurate, and regulatory-compliant dispensing of controlled substances used in elixir formulations. It ensures traceability, minimizes risks of misuse, and aligns with national regulatory requirements.
2. Scope
This SOP applies to all activities related to the dispensing of controlled substances in the Elixir Department. It includes material request, authorization, handling, weighing, labeling, documentation, and return of excess quantity if applicable.
3. Responsibilities
- Warehouse In-Charge:
- Ensure controlled substances are stored in designated secured locations.
- Maintain updated stock and access logs.
- Authorized Dispensing Officer:
- Perform accurate weighing and labeling of controlled substances.
- Ensure dispensing is done under supervision and with authorization.
- Production Supervisor:
- Supervise the entire dispensing activity and cross-verify the quantity.
- QA/QC Personnel:
- Approve the dispensed material and ensure traceability documentation is complete.
4. Accountability
The Production Head of the Elixir Department is accountable for enforcing this SOP. Only personnel authorized by the QA Head and registered under local drug control regulations shall dispense controlled substances.
5. Procedure
5.1 Authorization and Requisition
- Initiate a Controlled Substance Dispensing Requisition Form, signed by the Production Head.
- Verify material status (Approved) in inventory and ensure the substance is available.
- Ensure the person initiating and handling the substance is authorized and trained.
5.2 Secured Dispensing Setup
- Access the designated secure room/dispensing booth with limited authorized access.
- Ensure the area is monitored via CCTV and access logs are maintained.
- Verify the container label for:
- Material Name
- Batch Number
- Expiry Date
- Quantity in Stock
5.3 Weighing Procedure
- Use a calibrated analytical balance placed within the secure dispensing area.
- Weigh the required quantity as per the approved MBR. Ensure zero error tolerance.
- Record the actual quantity dispensed in the logbook and on the container label.
5.4 Labeling and Sealing
- Affix the “Controlled Substance Dispensed” label with:
- Name of Substance
- Quantity Dispensed
- Batch Number
- Date of Dispensing
- Dispensed By
- Verified By
- Seal the container and ensure the seal is tamper-evident.
- Transfer the dispensed container immediately to the designated storage area for production use.
5.5 Documentation and Return of Excess
- Enter details in the Material Dispensing Log (Annexure-1) and Controlled Substance Register.
- Attach the CoA of the material to the batch file (Annexure-2).
- Fill the Approval and Release Form (Annexure-3) and have it reviewed by QA.
- If any excess material remains, document the quantity and return it immediately to the secure storage with a return note.
5.6 Record Retention
- Retain all records, including access logs, requisition forms, and dispensing logs for a minimum of 5 years.
- Ensure digital records are password-protected and backed up regularly.
6. Abbreviations
- QA: Quality Assurance
- QC: Quality Control
- MBR: Manufacturing Batch Record
- SOP: Standard Operating Procedure
- CoA: Certificate of Analysis
7. Documents
- Material Dispensing Log (Annexure-1)
- Certificate of Analysis (Annexure-2)
- Approval and Release Form (Annexure-3)
8. References
- Narcotic Drugs and Psychotropic Substances Act (India)
- 21 CFR Part 1300–1321 – US DEA Controlled Substances Regulations
- WHO Guidelines on Controlled Substances Management
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 | Substance | Batch No. | Qty Dispensed | Dispensed By | Verified By |
|---|---|---|---|---|---|
| 11/04/2025 | Codeine Phosphate | CDP4521 | 0.200 kg | Rajesh Kumar | Sunita Reddy |
Annexure-2: Certificate of Analysis (CoA)
| Substance | Batch No. | Test | Result | Complies |
|---|---|---|---|---|
| Codeine Phosphate | CDP4521 | Identification | Positive | Yes |
Annexure-3: Approval and Release Form
| Date | Substance | Batch No. | Released By | Approved By | Remarks |
|---|---|---|---|---|---|
| 11/04/2025 | Codeine Phosphate | CDP4521 | Ajay Mehta | Manoj Verma | Approved for ELX-Batch-203 |
Revision History:
| Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By |
|---|---|---|---|---|
| 01/01/2024 | 1.0 | Initial SOP Release | New SOP Implementation | QA Head |
| 11/04/2025 | 2.0 | Format Update and Record Retention Policy Addition | Compliance with Revised Internal SOP Format | QA Head |