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

1. 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).
2. 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

1. 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).
2. 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

1. 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).
2. 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

1. 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).
2. 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

1. 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).
2. 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

1. Controlled Substance Receipt Log (Annexure-1)
2. Discrepancy Report Log (Annexure-2)
3. Controlled Substance Storage Log (Annexure-3)
4. Access Control Log (Annexure-4)
5. Controlled Substance Inventory Log (Annexure-5)
6. Controlled Substance Dispatch Log (Annexure-6)
7. Controlled Substance Disposal Log (Annexure-7)
8. Internal Audit Log (Annexure-8)
9. 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