for ensuring secure storage and handling of restricted drugs. The QA Manager is responsible for verifying compliance through audits and documentation reviews. The Security Officer is responsible for access control and monitoring.

5. Procedure

5.1 Secure Storage Requirements

1. Storage Area Specifications:
   • Restricted and schedule drugs must be stored in dedicated, locked storage areas with restricted access.
   • Storage areas should be constructed of durable materials and equipped with reinforced doors and tamper-evident locks.
   • Install CCTV cameras for continuous surveillance of storage areas.
   • Document storage specifications in the Restricted Drug Storage Log (Annexure-1).
2. Temperature and Environmental Controls:
   • Ensure that storage conditions meet the required temperature and humidity specifications as outlined in regulatory guidelines.
   • Monitor environmental conditions daily and document them in the Environmental Monitoring Log (Annexure-2).

5.2 Access Control Procedures

1. Authorized Personnel:
   • Only authorized personnel, as listed in the Authorized Personnel List (Annexure-3), may access the restricted storage areas.
   • Issue unique access credentials (keys, biometric access) to authorized personnel only.
2. Access Log Maintenance:
   • Maintain a detailed log of all entries and exits from the restricted storage areas in the Access Control Log (Annexure-4).
   • Record the name, designation, time of access, and purpose of entry for each authorized person.

5.3 Handling Procedures for Restricted Drugs

1. Receipt and Verification:
   • Upon receipt, verify the quantity and condition of restricted drugs against the delivery documentation.
   • Document the receipt in the Restricted Drug Receiving Log (Annexure-5).
2. Inventory Management:
   • Maintain an up-to-date inventory of all restricted drugs in the Restricted Drug Inventory Log (Annexure-6).
   • Perform weekly inventory audits to ensure accuracy and detect discrepancies.

5.4 Disposal and Destruction of Restricted Drugs

1. Disposal Authorization:
   • Obtain written authorization from regulatory authorities before disposing of any restricted or expired drugs.
   • Document disposal approvals in the Disposal Authorization Log (Annexure-7).
2. Destruction Procedures:
   • Ensure destruction is carried out in the presence of authorized personnel and follows environmentally safe methods.
   • Document destruction activities in the Drug Destruction Log (Annexure-8).

6. Abbreviations

• SOP: Standard Operating Procedure
• GMP: Good Manufacturing Practice
• QA: Quality Assurance
• CCTV: Closed-Circuit Television

7. Documents

1. Restricted Drug Storage Log (Annexure-1)
2. Environmental Monitoring Log (Annexure-2)
3. Authorized Personnel List (Annexure-3)
4. Access Control Log (Annexure-4)
5. Restricted Drug Receiving Log (Annexure-5)
6. Restricted Drug Inventory Log (Annexure-6)
7. Disposal Authorization Log (Annexure-7)
8. Drug Destruction Log (Annexure-8)

8. References

• Narcotic Drugs and Psychotropic Substances Act, 1985
• 21 CFR Part 1301 – DEA Regulations for Controlled Substances
• WHO Guidelines on Good Manufacturing Practices for Pharmaceutical Products

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

Annexure-1: Restricted Drug Storage Log

Date	Drug Name	Batch Number	Storage Location	Stored By
31/03/2025	Morphine Sulfate	MS-2025A	Secure Vault A	Ravi Kumar
31/03/2025	Fentanyl Citrate	FC-2025B	Secure Vault B	Neha Verma

Annexure-2: Environmental Monitoring Log

Date	Storage Area	Temperature (°C)	Humidity (%)	Checked By
31/03/2025	Secure Vault A	20°C	45%	Amit Joshi
31/03/2025	Secure Vault B	19°C	50%	Priya Singh

Annexure-3: Authorized Personnel List

Name	Designation	Access Level	Access ID
Ravi Kumar	Warehouse Supervisor	Full Access	RK001
Neha Verma	QA Manager	Audit Access	NV002

Annexure-4: Access Control Log

Date	Name	Time In	Time Out	Purpose of Access
31/03/2025	Ravi Kumar	09:00 AM	09:30 AM	Inventory Check
31/03/2025	Neha Verma	10:00 AM	10:20 AM	Audit Review

Annexure-5: Restricted Drug Receiving Log

Date	Drug Name	Batch Number	Quantity Received	Supplier	Received By
31/03/2025	Morphine Sulfate	MS-2025A	50 Vials	ABC Pharmaceuticals	Ravi Kumar
31/03/2025	Fentanyl Citrate	FC-2025B	100 Vials	XYZ Pharma Ltd.	Neha Verma

Annexure-6: Restricted Drug Inventory Log

Date	Drug Name	Batch Number	Quantity on Hand	Checked By
31/03/2025	Morphine Sulfate	MS-2025A	50 Vials	Amit Joshi
31/03/2025	Fentanyl Citrate	FC-2025B	100 Vials	Priya Singh

Annexure-7: Disposal Authorization Log

Date	Drug Name	Batch Number	Quantity for Disposal	Authorized By	Regulatory Approval Reference
31/03/2025	Morphine Sulfate	MS-2025A	5 Vials (Expired)	QA Manager	NDPS/2025/1234
31/03/2025	Fentanyl Citrate	FC-2025B	10 Vials (Damaged)	QA Manager	NDPS/2025/5678

Annexure-8: Drug Destruction Log

Date	Drug Name	Batch Number	Quantity Destroyed	Destruction Method	Witnessed By
31/03/2025	Morphine Sulfate	MS-2025A	5 Vials	Incineration	Ravi Kumar, Neha Verma
31/03/2025	Fentanyl Citrate	FC-2025B	10 Vials	Chemical Neutralization	Amit Joshi, Priya Singh

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
31/03/2025	2.0	Added Disposal and Destruction Documentation	Enhance Regulatory Compliance	QA Head