Standard Operating Procedure for Managing Storage of Controlled Substances in Compliance with Regulatory Bodies
| Department | Warehouse / Quality Assurance / Regulatory Affairs |
|---|---|
| SOP No. | SOP/RM/149/2025 |
| Supersedes | SOP/RM/149/2022 |
| Page No. | Page 1 of 15 |
| Issue Date | 18/03/2025 |
| Effective Date | 25/03/2025 |
| Review Date | 18/03/2026 |
1. Purpose
This Standard Operating Procedure (SOP) establishes the guidelines for the secure storage, handling, and documentation of controlled substances in compliance with national and international regulatory requirements. It ensures the integrity, security, and traceability of controlled substances within the warehouse.
2. Scope
This SOP applies to all personnel involved in the storage, handling, documentation, and disposal of controlled substances within the warehouse. It covers compliance with regulations from agencies such as the Central Drugs Standard Control Organization (CDSCO), Drug Enforcement Administration (DEA), and other applicable regulatory bodies.
3. Responsibilities
- Warehouse Personnel: Handle controlled substances following secure protocols and maintain accurate records of receipt, storage, and dispatch.
- Warehouse Manager: Ensure compliance with security measures, oversee the access control system, and maintain proper documentation.
- Regulatory Affairs Team: Ensure adherence to national and international regulatory guidelines and submit compliance reports.
- Quality Assurance (QA): Verify storage conditions, conduct periodic audits, and maintain documentation.
4. Accountability
The Warehouse Manager is accountable for ensuring that controlled substances are stored securely and handled according to regulatory guidelines. The Regulatory Affairs Manager is responsible for ensuring compliance with legal requirements and coordinating audits.
5. Procedure
5.1 Receipt of Controlled Substances
- Verification of Documentation:
- Ensure that all controlled substances are accompanied by the necessary regulatory documents (e.g., import/export licenses, certificates of analysis).
- Cross-verify delivery against the purchase order and shipping manifest.
- Document the receipt in the Controlled Substance Receipt Log (Annexure-1).
- Initial Inspection:
- Conduct a visual inspection for any damage or tampering with packaging.
- Ensure that seals are intact and labels are legible.
- Document any discrepancies in the Discrepancy Report Log (Annexure-2).
5.2 Storage of Controlled Substances
- Secure Storage Areas:
- Store controlled substances in a designated, secure, and locked area with restricted access.
- Ensure the storage area is equipped with surveillance cameras, alarm systems, and controlled temperature and humidity conditions.
- Document storage locations in the Controlled Substance Storage Log (Annexure-3).
- Access Control:
- Limit access to authorized personnel only, using key cards, biometric scanners, or secure logbooks.
- Maintain a record of all personnel with access privileges in the Access Control Log (Annexure-4).
5.3 Inventory Management
- Inventory Reconciliation:
- Perform regular inventory counts and reconcile with records to detect discrepancies.
- Report any discrepancies immediately to the QA and Regulatory Affairs teams.
- Document inventory counts in the Controlled Substance Inventory Log (Annexure-5).
- Real-Time Tracking:
- Utilize barcode or RFID tracking systems to maintain real-time location data of controlled substances.
- Ensure accurate entry of movement details in the tracking system.
5.4 Dispatch and Disposal Procedures
- Dispatch of Controlled Substances:
- Ensure that substances are dispatched only to authorized recipients with valid documentation.
- Use tamper-evident packaging and track shipments through secure carriers.
- Document dispatch activities in the Controlled Substance Dispatch Log (Annexure-6).
- Disposal of Expired or Unusable Substances:
- Dispose of controlled substances through authorized waste disposal agencies following regulatory guidelines.
- Ensure proper documentation of the disposal process in the Controlled Substance Disposal Log (Annexure-7).
5.5 Regulatory Compliance and Audits
- Internal Audits:
- Conduct periodic internal audits to ensure compliance with regulatory standards.
- Address any non-compliance issues with corrective and preventive actions.
- Document audit findings in the Internal Audit Log (Annexure-8).
- External Regulatory Audits:
- Prepare for regulatory inspections by maintaining up-to-date documentation and ensuring readiness of storage facilities.
- Respond promptly to any regulatory queries or findings.
- Document regulatory interactions in the Regulatory Audit Log (Annexure-9).
6. Abbreviations
- SOP: Standard Operating Procedure
- GMP: Good Manufacturing Practice
- QA: Quality Assurance
- CDSCO: Central Drugs Standard Control Organization
- DEA: Drug Enforcement Administration
7. Documents
- Controlled Substance Receipt Log (Annexure-1)
- Discrepancy Report Log (Annexure-2)
- Controlled Substance Storage Log (Annexure-3)
- Access Control Log (Annexure-4)
- Controlled Substance Inventory Log (Annexure-5)
- Controlled Substance Dispatch Log (Annexure-6)
- Controlled Substance Disposal Log (Annexure-7)
- Internal Audit Log (Annexure-8)
- Regulatory Audit Log (Annexure-9)
8. References
- 21 CFR Part 1301 – DEA Regulations for Controlled Substances
- CDSCO Guidelines for Storage and Distribution of Controlled Substances
- WHO Guidelines on Controlled Substance Management
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
Annexure-1: Controlled Substance Receipt Log
| Date | Material Name | Batch Number | Quantity Received | Supplier | Received By |
|---|---|---|---|---|---|
| 18/03/2025 | Morphine Sulfate | MS-00123 | 500 mg | ABC Pharmaceuticals | Ravi Kumar |
| 18/03/2025 | Diazepam | DZP-00456 | 1000 mg | XYZ Pharma Ltd. | Neha Verma |
Annexure-2: Discrepancy Report Log
| Date | Material Name | Batch Number | Discrepancy Identified | Action Taken | Reported By |
|---|---|---|---|---|---|
| 18/03/2025 | Morphine Sulfate | MS-00123 | Seal broken on one vial | Vial quarantined, supplier notified | Ravi Kumar |
| 18/03/2025 | Diazepam | DZP-00456 | Quantity mismatch (5 vials missing) | Inventory adjusted, investigation initiated | Neha Verma |
Annexure-3: Controlled Substance Storage Log
| Date | Material Name | Batch Number | Storage Location | Stored By | Verified By |
|---|---|---|---|---|---|
| 18/03/2025 | Morphine Sulfate | MS-00123 | Secure Cabinet A1 | Ravi Kumar | Priya Singh |
| 18/03/2025 | Diazepam | DZP-00456 | Secure Locker B2 | Neha Verma | Amit Joshi |
Annexure-4: Access Control Log
| Date | Employee Name | Access Time | Purpose of Access | Authorized By |
|---|---|---|---|---|
| 18/03/2025 | Ravi Kumar | 10:00 AM | Storage of received materials | Neha Verma |
| 18/03/2025 | Amit Joshi | 2:00 PM | Inventory reconciliation | Priya Singh |
Annexure-5: Controlled Substance Inventory Log
| Date | Material Name | Batch Number | Quantity on Hand | Reconciled By | Remarks |
|---|---|---|---|---|---|
| 18/03/2025 | Morphine Sulfate | MS-00123 | 495 mg | Priya Singh | Seal issue reported, quantity adjusted |
| 18/03/2025 | Diazepam | DZP-00456 | 995 mg | Amit Joshi | Quantity mismatch under investigation |
Annexure-6: Controlled Substance Dispatch Log
| Date | Material Name | Batch Number | Quantity Dispatched | Recipient | Dispatched By |
|---|---|---|---|---|---|
| 18/03/2025 | Morphine Sulfate | MS-00123 | 100 mg | XYZ Hospital | Ravi Kumar |
| 18/03/2025 | Diazepam | DZP-00456 | 200 mg | ABC Clinic | Neha Verma |
Annexure-7: Controlled Substance Disposal Log
| Date | Material Name | Batch Number | Quantity Disposed | Disposal Method | Disposed By |
|---|---|---|---|---|---|
| 18/03/2025 | Morphine Sulfate | MS-00123 | 5 mg | Incineration by licensed agency | Priya Singh |
| 18/03/2025 | Diazepam | DZP-00456 | 10 mg | Neutralization and chemical disposal | Amit Joshi |
Annexure-8: Internal Audit Log
| Date | Auditor | Area Audited | Findings | Corrective Actions | Status |
|---|---|---|---|---|---|
| 18/03/2025 | Neha Verma | Controlled Substance Storage | Discrepancy in diazepam quantity | Initiated investigation | Ongoing |
| 18/03/2025 | Priya Singh | Access Control System | No issues found | N/A | Resolved |
Annexure-9: Regulatory Audit Log
| Date | Regulatory Body | Auditor Name | Findings | Corrective Actions | Status |
|---|---|---|---|---|---|
| 18/03/2025 | CDSCO | Dr. Anil Sharma | Documentation incomplete for one batch | Updated records and submitted report | Resolved |
| 18/03/2025 | DEA | Ms. Rina Kapoor | Storage area temperature exceeded limit | Adjusted HVAC settings, issue monitored | Resolved |
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 |
| 18/03/2025 | 2.0 | Updated to include new regulatory guidelines | Alignment with revised CDSCO and DEA standards | QA Head |