Capsule: SOP for Handling Hazardous Materials in Dispensing – V 2.0

Posted on By

Capsule: SOP for Handling Hazardous Materials in Dispensing – V 2.0

Standard Operating Procedure for Handling Hazardous Materials in Dispensing

Department Capsule Manufacturing
SOP No. SOP/CM/010/2025
Supersedes SOP/CM/010/2022
Page No. Page 1 of 8
Issue Date 01/02/2025
Effective Date 05/02/2025
Review Date 01/02/2026

1. Purpose

To establish procedures for the safe handling of hazardous materials during the dispensing process in capsule manufacturing, ensuring worker safety and compliance with regulatory standards.

2. Scope

This SOP applies to all hazardous materials used in capsule manufacturing, including APIs and excipients classified as hazardous, during the dispensing process.

3. Responsibilities

  • Manufacturing Personnel: Responsible for adhering to the safe handling procedures when dispensing hazardous materials.
  • Quality Control (QC) Team: Ensures that hazardous materials are handled according to the defined procedures and meets safety and quality standards.
  • Safety Officer: Responsible for overseeing the implementation of safety measures for handling hazardous materials and ensuring compliance with health and safety regulations.
  • Quality Assurance (QA) Team: Ensures compliance with the SOP and monitors adherence to health and safety regulations.

4. Accountability

The Manufacturing Supervisor is accountable for ensuring the correct handling of hazardous materials during dispensing. The Safety Officer is responsible for monitoring and ensuring compliance with safety standards.

5. Procedure

5.1 Identification and Classification of Hazardous Materials

Before handling hazardous materials, ensure that they are identified and classified correctly:

  1. Check Material Safety Data Sheets (MSDS)

    1. Before dispensing hazardous materials, review the Material Safety Data Sheets (MSDS) for each material to understand its potential hazards, handling precautions, and emergency measures.
    2. Ensure that the MSDS is readily available to all personnel involved in the dispensing process.
  2. Hazard Classification

    1. Ensure that all hazardous materials are properly classified according to their risk (e.g., toxic, flammable, corrosive, etc.).
    2. Label hazardous materials with appropriate warning symbols and handling instructions.
See also  Capsule: SOP for Controlling Environmental Conditions During Dispensing - V 2.0

5.2 Personal Protective Equipment (PPE)

Personnel handling hazardous materials must wear the appropriate PPE to ensure safety:

  1. Required PPE

    1. Provide personnel with the appropriate PPE such as gloves, lab coats, face shields, respirators, and safety glasses based on the material’s hazard classification.
    2. Ensure that PPE is in good condition and properly fitted before starting the dispensing process.
  2. PPE Training

    1. Ensure that all personnel handling hazardous materials have received training on how to use PPE correctly.
    2. Provide refresher training to personnel on PPE requirements and usage periodically.

5.3 Handling Hazardous Materials

Ensure safe handling of hazardous materials during the dispensing process:

  1. Material Transfer

    1. Transfer hazardous materials carefully to avoid spills or exposure. Use enclosed containers or transfer systems designed for hazardous materials.
    2. Use mechanical aids (e.g., conveyors, automated systems) to handle large quantities of hazardous materials safely.
  2. Ventilation and Containment

    1. Ensure that the dispensing area is well-ventilated, particularly when handling volatile or toxic materials.
    2. Use fume hoods or local exhaust ventilation systems where appropriate to minimize inhalation hazards.
  3. Minimize Exposure

    1. Use enclosed systems for dispensing when possible to reduce the risk of exposure to hazardous materials.
    2. Limit the amount of hazardous material dispensed at a time to reduce the risk of spills or contamination.

5.4 Spill and Exposure Response

In case of a spill or accidental exposure to hazardous materials, follow these steps:

  1. Immediate Response

    1. If a spill occurs, immediately contain it using appropriate spill containment materials, such as absorbent pads or neutralizing agents, based on the type of material.
    2. If personnel are exposed to hazardous materials, follow emergency procedures, including decontamination and seeking medical attention if necessary.
  2. Report the Incident

    1. Immediately report the spill or exposure to the Safety Officer and document the incident in the Incident Report (Annexure-1).
    2. Investigate the cause of the incident and take corrective actions to prevent recurrence.
  3. Decontamination and Cleanup

    1. Clean up the spill using the appropriate decontamination procedure and disposal methods, as outlined in the MSDS.
    2. Ensure that the area is thoroughly cleaned and that all hazardous waste is properly disposed of in accordance with regulatory guidelines.
See also  Capsule: SOP for Ensuring Uniformity of Capsule Weight During Production - V 2.0

5.5 Disposal of Hazardous Materials

Proper disposal procedures must be followed to ensure safety and environmental protection:

  1. Waste Segregation

    1. Segregate hazardous waste from non-hazardous waste to ensure proper disposal.
    2. Ensure that containers used for hazardous waste are clearly labeled and sealed to prevent accidental exposure or leaks.
  2. Disposal Method

    1. Dispose of hazardous waste in accordance with environmental and safety regulations, ensuring that it is sent to approved disposal facilities.
    2. Document the disposal of hazardous materials in the Hazardous Waste Disposal Log (Annexure-2), including the material, quantity, and disposal method used.

5.6 Documentation and Record-Keeping

Ensure proper documentation of all activities involving hazardous materials:

  1. Material Handling Log

    1. Document the handling of hazardous materials, including quantities dispensed, personnel involved, and safety measures taken, in the Material Handling Log (Annexure-3).
  2. Disposal Records

    1. Maintain a record of hazardous material disposal in the Hazardous Waste Disposal Log (Annexure-2), including the waste type, quantity, and disposal method.
  3. Incident Report

    1. All spills, exposures, or accidents involving hazardous materials must be documented in the Incident Report (Annexure-1), and corrective actions must be taken and recorded.
See also  Capsule: SOP for Preparing Gelatin Solution for Capsule Shells - V 2.0

6. Abbreviations

  • SOP: Standard Operating Procedure
  • MSDS: Material Safety Data Sheet
  • QA: Quality Assurance
  • QC: Quality Control
  • CAPA: Corrective and Preventive Action
  • PO: Purchase Order
  • API: Active Pharmaceutical Ingredient

7. Documents

  1. Material Handling Log (Annexure-3)
  2. Hazardous Waste Disposal Log (Annexure-2)
  3. Incident Report (Annexure-1)

8. References

  • 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals (US FDA)
  • EU GMP Guidelines Part I – Basic Requirements for Medicinal Products
  • OSHA Guidelines for Handling Hazardous Materials

9. SOP Version

Version: 2.0

10. Approval Section

Prepared By Checked By Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Incident Report

Date Material Involved Incident Description Root Cause Corrective Action Preventive Action
04/02/2025 API-123 Exposure to toxic dust Improper PPE use Issued new PPE to personnel Reinforced PPE training and protocols

Annexure-2: Hazardous Waste Disposal Log

Date Material Type Quantity Disposal Method
05/02/2025 Hazardous API 10 kg Incineration

Annexure-3: Material Handling Log

Date Material Name Batch Number Handled By Quantity Handled
06/02/2025 Excipient-456 Batch 12345 John Doe 100 g

Revision History:

You said:
Continue
ChatGPT said:
Certainly! Here’s the continuation of SOP 10: SOP for Handling Hazardous Materials in Dispensing:

html
Copy

Revision Date Revision No. Revision Details Reason for Revision Approved By
01/01/2024 1.0 Initial Version New SOP Creation QA Head
01/02/2025 2.0 Updated safety protocols and disposal methods Standardization and enhanced safety measures QA Head
Capsules V 2.0 Tags:, , , , , , , , , , , , , , , , , , , , , , , , , , , ,