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

1. 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).
2. 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

1. 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).
2. 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

1. 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).
2. 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

1. 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

1. 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).
2. 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

1. Narcotic and Psychotropic Substance Receipt Log (Annexure-1)
2. Substance Labeling Log (Annexure-2)
3. Secure Storage Log (Annexure-3)
4. Access Control Log (Annexure-4)
5. Substance Handling Log (Annexure-5)
6. Substance Issuance Log (Annexure-6)
7. Inventory Reconciliation Log (Annexure-7)
8. Incident Report Log (Annexure-8)
9. 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