SOP for Handling Highly Potent Substances

1) Purpose

To establish procedures for the safe handling, storage, and disposal of highly potent substances to ensure employee safety and regulatory compliance.

2) Scope

This SOP applies to all personnel involved in the handling of highly potent substances within the pharmaceutical manufacturing facility.

3) Responsibilities

Environmental Health and Safety (EHS) Department: Responsible for developing and implementing safety protocols and conducting regular risk assessments.
Manufacturing Personnel: Responsible for adhering to procedures outlined in this SOP and participating in training programs.
Quality Assurance: Responsible for auditing and ensuring compliance with SOP requirements.
Facility Management: Responsible for ensuring adequate infrastructure and equipment for safe handling of potent substances.

4) Procedure

1. Risk Assessment and Control Measures:
   1. Conduct a risk assessment to identify hazards associated with each potent substance.
   2. Implement engineering controls such as containment systems, ventilated enclosures, and closed systems.
   3. Provide appropriate personal protective equipment (PPE) including gloves, goggles, and respiratory protection.
2. Handling Procedures:
   1. Receive and store potent substances in designated areas with restricted access.
   2. Label all containers clearly with substance name, potency, hazard warnings, and expiration date.
   3. Use dedicated equipment and tools for handling potent substances.
   4. Minimize exposure through proper handling techniques and containment.
3. Spill and Emergency Response:
   1. Develop spill response procedures and ensure availability of spill kits.
   2. Train personnel on spill response protocols and evacuation procedures.
   3. Report all spills and incidents immediately to EHS and follow cleanup procedures.
4. Disposal and Waste Management:
   1. Segregate waste according to hazard classification and disposal requirements.
   2. Dispose of potent substances and contaminated materials in compliance with regulatory guidelines.
   3. Document disposal activities and maintain records of waste manifests.

5) Abbreviations, if any

SOP – Standard Operating Procedure

EHS – Environmental Health and Safety

PPE – Personal Protective Equipment

6) Documents, if any

• Risk Assessment Report
• Training Records
• Spill Response Plan
• Waste Disposal Manifests

7) Reference, if any

OSHA Standard 29 CFR 1910.1200 – Hazard Communication

8) SOP Version

Version 1.0