SOP Guide for Pharma

SOP for Controlled Storage of Radioactive or Hazardous Raw Materials – V 2.0

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SOP for Controlled Storage of Radioactive or Hazardous Raw Materials – V 2.0

Standard Operating Procedure for Controlled Storage of Radioactive or Hazardous Raw Materials

Department Warehouse / Quality Assurance / Safety
SOP No. SOP/RM/135/2025
Supersedes SOP/RM/135/2022
Page No. Page 1 of 15
Issue Date 28/02/2025
Effective Date 05/03/2025
Review Date 28/02/2026

1. Purpose

This Standard Operating Procedure (SOP) establishes guidelines for the safe and compliant storage of radioactive and hazardous raw materials. It ensures the protection of personnel, property, and the environment while maintaining compliance with regulatory requirements.

2. Scope

This SOP applies to all radioactive and hazardous raw materials received, stored, and handled within the warehouse facilities. It covers materials classified as flammable, corrosive, toxic, carcinogenic, reactive, or radioactive.

3. Responsibilities

  • Warehouse Personnel: Ensure proper storage, labeling, and handling of hazardous and radioactive materials.
  • Warehouse Manager: Supervise the controlled storage process and ensure compliance with safety and regulatory guidelines.
  • Quality Assurance (QA): Verify compliance with Good Manufacturing Practices (GMP) and ensure proper documentation of storage conditions.
  • Safety Officer: Ensure safety procedures are followed and proper Personal Protective Equipment (PPE) is used during handling and storage.
  • Radiation Safety Officer (RSO): Oversee the storage and handling of radioactive materials and ensure compliance with radiation protection regulations.

4. Accountability

The Warehouse Manager is accountable for ensuring hazardous and radioactive materials are stored safely and in compliance with regulatory guidelines. The QA Manager and Radiation Safety Officer are responsible for verifying adherence to safety protocols and proper documentation.

5. Procedure

5.1 Receiving and Inspection of Hazardous and Radioactive Materials

  1. Initial Inspection:
    • Inspect all incoming hazardous and radioactive materials for leaks, damage, or improper labeling.
    • Ensure that containers are intact, sealed, and labeled with the appropriate hazard symbols and handling instructions.
    • Verify accompanying documentation, such as the Certificate of Analysis (COA), Material Safety Data Sheet (MSDS), and radiation transport certificates, if applicable.
    • Document receipt and inspection in the Hazardous Material Receiving Log (Annexure-1).
  2. Verification of Documentation:
    • Ensure all regulatory documents are in place before accepting materials into storage.
    • Record verification in the Documentation Verification Log (Annexure-2).
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5.2 Storage Conditions for Hazardous and Radioactive Materials

  1. Controlled Access Areas:
    • Store hazardous and radioactive materials in restricted-access areas with controlled entry, monitored by keycards or biometric access systems.
    • Document access permissions in the Access Control Log (Annexure-3).
  2. Storage Environment:
    • Store materials in well-ventilated, temperature-controlled environments, ensuring segregation based on material compatibility (e.g., flammable materials separate from oxidizers).
    • For radioactive materials, use lead-shielded storage containers or cabinets, with regular radiation monitoring in place.
    • Document storage conditions in the Storage Condition Log (Annexure-4).

5.3 Labeling and Segregation of Hazardous and Radioactive Materials

  1. Proper Labeling:
    • Ensure all hazardous and radioactive materials are labeled with hazard symbols, batch numbers, expiry dates, and storage conditions.
    • Radioactive materials should be marked with the trefoil radiation symbol and the words “Caution – Radioactive Material.”
    • Record labeling activities in the Labeling Log (Annexure-5).
  2. Segregation Protocols:
    • Segregate incompatible materials, such as acids from bases and flammable materials from oxidizers.
    • Ensure radioactive materials are stored separately from non-radioactive materials, with adequate shielding and signage.
    • Document segregation protocols in the Segregation Log (Annexure-6).

5.4 Radiation Safety and Monitoring

  1. Radiation Monitoring Procedures:
    • Regularly monitor radiation levels in storage areas using calibrated Geiger counters or dosimeters.
    • Ensure that radiation exposure levels do not exceed permissible limits as defined by regulatory authorities.
    • Document monitoring results in the Radiation Monitoring Log (Annexure-7).
  2. Personnel Safety Measures:
    • Ensure personnel handling radioactive materials wear dosimeters and appropriate PPE.
    • Rotate staff handling radioactive materials to minimize exposure time.
    • Document PPE usage and monitoring in the Personnel Safety Log (Annexure-8).
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5.5 Spill and Emergency Response Procedures

  1. Spill Prevention:
    • Ensure all containers are securely closed and stored in spill-containment trays or cabinets.
    • Inspect storage areas regularly for signs of leaks or spills.
    • Document inspections in the Spill Prevention Log (Annexure-9).
  2. Emergency Spill Response:
    • In the event of a spill, immediately evacuate the area, contain the spill if safe to do so, and notify the Safety Officer and RSO.
    • Use appropriate spill kits and follow emergency response protocols outlined in the MSDS or radiation safety manual.
    • Document spill incidents and corrective actions in the Spill Incident Log (Annexure-10).

6. Abbreviations

  • SOP: Standard Operating Procedure
  • GMP: Good Manufacturing Practice
  • QA: Quality Assurance
  • PPE: Personal Protective Equipment
  • RSO: Radiation Safety Officer
  • MSDS: Material Safety Data Sheet

7. Documents

  1. Hazardous Material Receiving Log (Annexure-1)
  2. Documentation Verification Log (Annexure-2)
  3. Access Control Log (Annexure-3)
  4. Storage Condition Log (Annexure-4)
  5. Labeling Log (Annexure-5)
  6. Segregation Log (Annexure-6)
  7. Radiation Monitoring Log (Annexure-7)
  8. Personnel Safety Log (Annexure-8)
  9. Spill Prevention Log (Annexure-9)
  10. Spill Incident Log (Annexure-10)

8. References

  • 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals
  • WHO GMP Guidelines
  • International Atomic Energy Agency (IAEA) Radiation Safety Standards
  • OSHA Hazardous Materials Handling Standards

9. SOP Version

Version: 2.0

10. Approval Section

Prepared By Checked By Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Hazardous Material Receiving Log

Date Material Name Batch Number Condition at Receipt Inspected By
28/02/2025 Radioactive Isotope A Batch9876 No Damage Ravi Kumar
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Annexure-2: Documentation Verification Log

Date Material Name Document Verified Verified By
28/02/2025 Radioactive Isotope A COA, MSDS, Radiation Transport Certificate Sunita Sharma

Annexure-3: Access Control Log

Date Personnel Name Access Time Exit Time Authorized By
28/02/2025 Amit Joshi 10:00 AM 10:45 AM Priya Singh

Annexure-4: Storage Condition Log

Date Material Name Temperature (°C) Humidity (%) Storage Area
28/02/2025 Radioactive Isotope A 22 45 Radioactive Storage Room 1

Annexure-5: Labeling Log

Date Material Name Label Applied Applied By
28/02/2025 Radioactive Isotope A Radioactive Symbol with Handling Instructions Neha Verma

Annexure-6: Segregation Log

Date Material Name Segregation Type Location Segregated By
28/02/2025 Corrosive Chemical B Separated from Flammable Materials Hazardous Material Zone B Ravi Kumar

Annexure-7: Radiation Monitoring Log

Date Material Name Radiation Level (µSv/h) Monitoring Device Used Monitored By
28/02/2025 Radioactive Isotope A 0.5 Geiger Counter Model X123 Rajeev Menon

Annexure-8: Personnel Safety Log

Date Personnel Name PPE Used Dosimeter Reading (µSv) Verified By
28/02/2025 Amit Joshi Lead Apron, Gloves, Goggles 0.3 Priya Singh

Annexure-9: Spill Prevention Log

Date Inspection Area Findings Corrective Actions Inspected By
28/02/2025 Radioactive Storage Room 1 No leaks found N/A Ravi Kumar

Annexure-10: Spill Incident Log

Date Material Name Spill Description Corrective Action Taken Reported By
28/02/2025 Corrosive Chemical B Minor leak detected in container seal Container replaced, spill area cleaned with neutralizing agent Sunita Sharma

Revision History:

Revision Date Revision No. Revision Details Reason for Revision Approved By
01/01/2024 1.0 Initial Version New SOP QA Head
28/02/2025 2.0 Updated Procedures for Radioactive Material Storage Compliance with Updated Regulatory Guidelines QA Head
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