Standard Operating Procedure for Security Management

Purpose

The purpose of this SOP is to establish procedures for maintaining security measures to safeguard personnel, facilities, and assets within the pharmaceutical distribution facility, in compliance with regulatory requirements and Good Distribution Practice (GDP) guidelines.

Scope

This SOP applies to all personnel, visitors, and contractors present within the distribution facility, as well as external stakeholders, including suppliers, customers, and regulatory authorities.

Responsibilities

• The Security Officer is responsible for implementing and maintaining security measures, including access control, surveillance, and incident response.
• The Facilities Management Team is responsible for ensuring the physical security of the distribution facility, including perimeter security and building access.
• All personnel are responsible for adhering to security protocols and reporting any security concerns or incidents to the Security Officer or management.

Procedure

1. Access Control:
   • Implement access control measures to restrict entry to authorized personnel only, including the use of key cards, biometric systems, or access codes.
   • Monitor and record access to restricted areas, including entry and exit times, to maintain accountability.
2. Perimeter Security:
   • Ensure the perimeter of the distribution facility is secure, with appropriate fencing, gates, and barriers to prevent unauthorized access.
   • Regularly inspect perimeter security measures for signs of damage or tampering and address any vulnerabilities promptly.
3. Surveillance Systems:
   • Install surveillance cameras in strategic locations throughout the facility to monitor activities and deter unauthorized behavior.
   • Monitor surveillance feeds in real-time and maintain video recordings for review and investigation purposes.
4. Incident Response:
   • Establish procedures for responding to security incidents, including breaches, thefts, or unauthorized access attempts.
   • Designate specific personnel or teams responsible for initiating and managing incident response protocols.
5. Training and Awareness:
   • Provide security training to all personnel on security policies, procedures, and emergency response protocols.
   • Promote security awareness through regular communication, signage, and reminders within the facility.
6. Security Audits and Reviews:
   • Conduct regular security audits and reviews to assess the effectiveness of security measures and identify areas for improvement.
   • Address any deficiencies or non-compliance issues identified during security audits through corrective actions.

Abbreviations

• GDP – Good Distribution Practice

Documents

Reference documents related to security management may include:

• Security policies and procedures
• Access control logs
• Surveillance footage archives
• Incident response plans
• Security audit reports

Reference

Good Distribution Practice Guidelines

SOP Version

Version 1.0