Standard Operating Procedure for Secure Storage of Narcotic and Psychotropic Substances
| Department | Warehouse / Quality Assurance / Security |
|---|---|
| SOP No. | SOP/RM/143/2025 |
| Supersedes | SOP/RM/143/2022 |
| Page No. | Page 1 of 15 |
| Issue Date | 12/03/2025 |
| Effective Date | 19/03/2025 |
| Review Date | 12/03/2026 |
1. Purpose
This Standard Operating Procedure (SOP) outlines the requirements for the secure storage, handling, and documentation of narcotic and psychotropic substances to comply with regulatory authorities and ensure safety and security within the warehouse facility.
2. Scope
This SOP applies to all narcotic and psychotropic substances received, stored, and handled within the facility, including those used for pharmaceutical manufacturing and research purposes.
3. Responsibilities
- Warehouse Personnel: Ensure proper storage, handling, and documentation of narcotic and psychotropic substances.
- Security Officer: Monitor secure storage areas, control access, and report any discrepancies.
- Warehouse Manager: Supervise the receipt, storage, and issuance of substances, ensuring compliance with security protocols.
- Quality Assurance (QA): Review documentation and ensure compliance with regulatory guidelines.
4. Accountability
The Warehouse Manager and Security Officer are accountable for the secure storage and handling of narcotic and psychotropic substances. The QA Manager is responsible for reviewing documentation to ensure compliance with regulatory and GMP standards.
5. Procedure
5.1 Receipt and Identification
- Receiving Procedures:
- Upon receipt, verify narcotic and psychotropic substances against the purchase order (PO) and Certificate of Analysis (COA).
- Inspect packaging for tampering and cross-check batch numbers and quantities.
- Document receipt details in the Narcotic and Psychotropic Substance Receipt Log (Annexure-1).
- Labeling Requirements:
- Clearly label all substances with the product name, batch number, storage requirements, and appropriate hazard symbols.
- Ensure tamper-evident seals are intact and record labeling in the Substance Labeling Log (Annexure-2).
5.2 Secure Storage Requirements
- Designated Storage Areas:
- Store substances in locked, restricted-access cabinets or rooms equipped with surveillance cameras.
- Ensure temperature and humidity controls are maintained as per regulatory requirements.
- Document storage details in the Secure Storage Log (Annexure-3).
- Access Control:
- Limit access to authorized personnel only, and maintain an access control log.
- Use biometric or keycard access systems where applicable.
- Record access details in the Access Control Log (Annexure-4).
5.3 Handling and Issuance
- Handling Procedures:
- Handle substances in designated areas using appropriate Personal Protective Equipment (PPE).
- Ensure accurate documentation of handling activities in the Substance Handling Log (Annexure-5).
- Issuance Procedures:
- Issue substances only with proper authorization, recording the quantity and recipient details.
- Document issuance in the Substance Issuance Log (Annexure-6).
5.4 Inventory Management and Reconciliation
- Inventory Tracking:
- Maintain an updated inventory of all narcotic and psychotropic substances.
- Conduct monthly reconciliations to verify physical stock against inventory records.
- Document reconciliation activities in the Inventory Reconciliation Log (Annexure-7).
5.5 Incident Reporting and Security Breaches
- Incident Reporting:
- Immediately report any discrepancies, theft, or unauthorized access to the Warehouse Manager and Security Officer.
- Document incidents in the Incident Report Log (Annexure-8).
- Corrective Actions:
- Conduct investigations into security breaches and implement corrective actions to prevent recurrence.
- Document corrective actions in the Corrective Action Log (Annexure-9).
6. Abbreviations
- SOP: Standard Operating Procedure
- GMP: Good Manufacturing Practice
- QA: Quality Assurance
- PPE: Personal Protective Equipment
- PO: Purchase Order
- COA: Certificate of Analysis
7. Documents
- Narcotic and Psychotropic Substance Receipt Log (Annexure-1)
- Substance Labeling Log (Annexure-2)
- Secure Storage Log (Annexure-3)
- Access Control Log (Annexure-4)
- Substance Handling Log (Annexure-5)
- Substance Issuance Log (Annexure-6)
- Inventory Reconciliation Log (Annexure-7)
- Incident Report Log (Annexure-8)
- Corrective Action Log (Annexure-9)
8. References
- Narcotic Drugs and Psychotropic Substances Act, 1985 (India)
- 21 CFR Part 1301 – DEA Requirements for Controlled Substances
- WHO GMP Guidelines for Controlled Substances
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Narcotic and Psychotropic Substance Receipt Log
| Date | Substance Name | Batch Number | Quantity Received | Received By |
|---|---|---|---|---|
| 12/03/2025 | Morphine Sulfate | MS-1234 | 500 vials | Ravi Kumar |
| 12/03/2025 | Diazepam | DZP-5678 | 300 ampoules | Neha Verma |
Annexure-2: Substance Labeling Log
| Date | Substance Name | Batch Number | Labeling Details | Label Verified By |
|---|---|---|---|---|
| 12/03/2025 | Morphine Sulfate | MS-1234 | Hazard Label, Batch Number, Storage Conditions | Ravi Kumar |
| 12/03/2025 | Diazepam | DZP-5678 | Controlled Substance Mark, Expiry Date | Neha Verma |
Annexure-3: Secure Storage Log
| Date | Substance Name | Batch Number | Storage Location | Storage Conditions | Stored By |
|---|---|---|---|---|---|
| 12/03/2025 | Morphine Sulfate | MS-1234 | Controlled Access Vault A1 | Temperature: 20-25°C, Restricted Access | Neha Verma |
| 12/03/2025 | Diazepam | DZP-5678 | Locked Cabinet B2 | Ambient, Tamper-Evident Seal | Amit Joshi |
Annexure-4: Access Control Log
| Date | Employee Name | Access Type (Entry/Exit) | Time | Substance Accessed | Authorized By |
|---|---|---|---|---|---|
| 12/03/2025 | Ravi Kumar | Entry | 09:00 AM | Morphine Sulfate | Priya Singh |
| 12/03/2025 | Neha Verma | Exit | 10:30 AM | Diazepam | Ravi Kumar |
Annexure-5: Substance Handling Log
| Date | Substance Name | Batch Number | Handling Procedure | Handled By | Verified By |
|---|---|---|---|---|---|
| 12/03/2025 | Morphine Sulfate | MS-1234 | Transferred for QC Testing | Neha Verma | Amit Joshi |
| 12/03/2025 | Diazepam | DZP-5678 | Repackaged into Unit Dose Forms | Ravi Kumar | Priya Singh |
Annexure-6: Substance Issuance Log
| Date | Substance Name | Batch Number | Quantity Issued | Issued To | Issued By |
|---|---|---|---|---|---|
| 12/03/2025 | Morphine Sulfate | MS-1234 | 100 vials | QC Laboratory | Neha Verma |
| 12/03/2025 | Diazepam | DZP-5678 | 50 ampoules | Formulation Department | Ravi Kumar |
Annexure-7: Inventory Reconciliation Log
| Date | Substance Name | Batch Number | Physical Count | Recorded Quantity | Discrepancy (if any) | Verified By |
|---|---|---|---|---|---|---|
| 12/03/2025 | Morphine Sulfate | MS-1234 | 400 vials | 400 vials | None | Amit Joshi |
| 12/03/2025 | Diazepam | DZP-5678 | 250 ampoules | 250 ampoules | None | Priya Singh |
Annexure-8: Incident Report Log
| Date | Substance Name | Batch Number | Incident Description | Action Taken | Reported By |
|---|---|---|---|---|---|
| 12/03/2025 | Morphine Sulfate | MS-1234 | Unusual Access Attempt Detected | Access Denied, Security Alert Raised | Ravi Kumar |
| 12/03/2025 | Diazepam | DZP-5678 | Minor Labeling Error Identified | Corrected and Reverified | Neha Verma |
Annexure-9: Corrective Action Log
| Date | Incident Description | Corrective Action Taken | Responsible Person | Verified By |
|---|---|---|---|---|
| 12/03/2025 | Unauthorized Access Attempt to Controlled Vault | Security Protocols Updated, Staff Re-trained | Priya Singh | Amit Joshi |
| 12/03/2025 | Labeling Error on Diazepam Batch | Re-labeled and Implemented Additional Checkpoints | Ravi Kumar | Neha Verma |
Revision History:
| Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By |
|---|---|---|---|---|
| 01/01/2024 | 1.0 | Initial Version | New SOP Implementation | QA Head |
| 12/03/2025 | 2.0 | Updated Security Protocols and Documentation Requirements | Alignment with Revised Regulatory Guidelines | QA Head |