SOP for Quarantine Area Entry Restrictions and Security Measures – V 2.0

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SOP for Quarantine Area Entry Restrictions and Security Measures – V 2.0

Standard Operating Procedure for Quarantine Area Entry Restrictions and Security Measures

Department Warehouse / Quality Assurance / Security
SOP No. SOP/RM/064/2025
Supersedes SOP/RM/064/2022
Page No. Page 1 of 15
Issue Date 01/02/2025
Effective Date 05/02/2025
Review Date 01/02/2026

1. Purpose

This Standard Operating Procedure (SOP) outlines the entry restrictions and security measures for the quarantine area in order to prevent unauthorized access, ensure the integrity of quarantined raw materials, and maintain compliance with Good Manufacturing Practices (GMP).

2. Scope

This SOP applies to all personnel, including Warehouse, Quality Assurance (QA), Quality Control (QC), and Security staff, who require access to the quarantine area for material handling, inspection, sampling, and documentation purposes.

3. Responsibilities

  • Warehouse Personnel: Ensure compliance with quarantine entry procedures and maintain proper documentation for materials handled.
  • Quality Assurance (QA): Oversee compliance with GMP regulations and approve access for necessary personnel.
  • Security Personnel: Control access to the quarantine area, maintain entry/exit logs, and monitor for unauthorized entry.
  • Quality Control (QC): Conduct sampling and testing of quarantined materials while adhering to access protocols.

4. Accountability

The Warehouse Manager is responsible for ensuring that all personnel comply with quarantine entry procedures. The

QA Manager oversees adherence to GMP and security requirements. The Security Manager ensures that unauthorized personnel are prevented from accessing the quarantine area, and all entry and exit activities are logged and monitored.

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5. Procedure

5.1 Quarantine Area Access Control

  1. Authorized Personnel Only:

    • Access to the quarantine area is restricted to authorized Warehouse, QA, QC, and Security personnel.
    • A list of authorized personnel must be maintained and updated monthly by the Warehouse Manager (Annexure-1).
    • Temporary access for non-authorized personnel (e.g., auditors) must be approved in writing by the QA Manager.
  2. Identification Requirements:

    • All personnel entering the quarantine area must wear visible ID badges at all times.
    • Visitors must sign in and out in the Quarantine Visitor Log (Annexure-2) and be accompanied by authorized staff.

5.2 Entry and Exit Protocols

  1. Sign-In/Sign-Out Procedures:

    • All personnel must sign in and out in the Quarantine Entry Log (Annexure-3) upon entering and exiting the area.
    • Security personnel are responsible for verifying sign-ins and ensuring compliance with entry protocols.
  2. Personal Protective Equipment (PPE):

    • Personnel must wear appropriate PPE, including gloves, lab coats, and hairnets, before entering the quarantine area.
    • PPE must be disposed of or sanitized according to facility guidelines before exiting the area.

5.3 Security Measures in the Quarantine Area

  1. Physical Security Measures:

    • The quarantine area must be secured with access-controlled doors and monitored by CCTV cameras.
    • Doors must remain locked at all times, and access is only granted via authorized keycards or biometric systems.
  2. Security Monitoring:

    • Security personnel must conduct routine checks every two hours and document findings in the Quarantine Security Log (Annexure-4).
    • Any security breaches or unauthorized access attempts must be reported immediately to the QA Manager.
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5.4 Handling of Unauthorized Access or Breaches

  1. Incident Identification:

    • If unauthorized personnel are found in the quarantine area, they must be escorted out immediately by Security personnel.
    • The incident must be reported to the QA Manager and documented in the Unauthorized Access Incident Report (Annexure-5).
  2. Investigation and Corrective Actions:

    • The QA Manager will investigate the incident, determine the cause, and implement corrective actions if necessary.
    • All corrective actions must be recorded in the Corrective Action Log (Annexure-6).

6. Abbreviations

  • SOP: Standard Operating Procedure
  • GMP: Good Manufacturing Practice
  • QA: Quality Assurance
  • QC: Quality Control
  • PPE: Personal Protective Equipment

7. Documents

  1. Authorized Personnel List (Annexure-1)
  2. Quarantine Visitor Log (Annexure-2)
  3. Quarantine Entry Log (Annexure-3)
  4. Quarantine Security Log (Annexure-4)
  5. Unauthorized Access Incident Report (Annexure-5)
  6. Corrective Action Log (Annexure-6)

8. References

  • 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals
  • ICH Q7 – Good Manufacturing Practice for Active Pharmaceutical Ingredients
  • EU Guidelines on Good Distribution Practices (GDP)

9. SOP Version

Version: 2.0

10. Approval Section

Prepared By Checked By Approved By
Signature
Date
Name
Designation
Department

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11. Annexures

Annexure-1: Authorized Personnel List

Employee Name Department Access Level Authorized By Remarks
Ravi Kumar Warehouse Full Access QA Manager Updated Monthly
Sunita Sharma Quality Control Sampling Access QA Manager Valid for 6 Months

Annexure-2: Quarantine Visitor Log

Date Visitor Name Company/Department Reason for Visit Accompanied By Sign-In Time Sign-Out Time
01/02/2025 Anil Mehta Regulatory Auditor Inspection Ravi Kumar 10:00 AM 11:30 AM

Annexure-3: Quarantine Entry Log

Date Employee Name Department Purpose of Entry Sign-In Time Sign-Out Time
01/02/2025 Ravi Kumar Warehouse Material Storage 09:00 AM 09:45 AM
01/02/2025 Sunita Sharma QC Sampling 11:00 AM 12:00 PM

Annexure-4: Quarantine Security Log

Date Security Personnel Time of Check Observations Actions Taken
01/02/2025 Ajay Singh 02:00 PM All Secure Routine Check Completed

Annexure-5: Unauthorized Access Incident Report

Date Incident Description Person Involved Reported By Actions Taken
01/02/2025 Unauthorized Entry Attempt Unidentified Visitor Ajay Singh Escorted Out and Report Filed

Annexure-6: Corrective Action Log

Date Incident Corrective Action Taken Responsible Person Follow-Up Required
01/02/2025 Unauthorized Entry Attempt Reviewed Security Protocols QA Manager Yes

Revision History:

Revision Date Revision No. Revision Details Reason for Revision Approved By
01/01/2024 1.0 Initial Version New SOP QA Head
01/02/2025 2.0 Enhanced Security Measures and Updated Documentation Compliance Improvement QA Head
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