SOP for Ensuring GMP Compliance in Hazardous Material Handling

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SOP for Ensuring GMP Compliance in Hazardous Material Handling

Standard Operating Procedure for Ensuring GMP Compliance in Hazardous Material Handling

1) Purpose

The purpose of this SOP is to ensure that hazardous material handling within the facility complies with Good Manufacturing Practices (GMP) to maintain product integrity, personnel safety, and regulatory compliance.

2) Scope

This SOP applies to all departments handling hazardous materials, including storage, transport, usage, and disposal, in GMP-regulated facilities such as pharmaceutical manufacturing, food production, and chemical processing units.

3) Responsibilities

  • Supervisors: Ensure GMP procedures are followed during hazardous material handling and monitor compliance.
  • Operators: Adhere to GMP guidelines for safe handling, use proper PPE, and document all activities.
  • Quality Assurance (QA): Verify GMP compliance, perform inspections, and review documentation.
  • Safety Officers: Oversee risk assessments, provide safety training, and address compliance gaps.
  • Management: Allocate resources and ensure GMP standards are consistently upheld.

4) Procedure

4.1 GMP Principles in Hazardous Material Handling

  1. Principle 1: Ensuring Material Traceability
    • Maintain accurate records of hazardous material receipt, storage, and usage.
    • Ensure batch numbers, supplier details, and expiry dates are recorded.
    • Implement inventory systems that align with GMP traceability requirements.

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  2. Principle 2: Contamination Prevention
    • Segregate hazardous materials from raw materials, intermediates, and finished products.
    • Store materials in labeled, sealed containers to prevent contamination.
    • Designate controlled areas with physical barriers
or ventilation for hazardous material handling.
  • Principle 3: Documentation
    • Ensure all processes are documented in line with GMP requirements.
    • Maintain records for:
      • Material receipts
      • Handling logs
      • Storage conditions
      • Disposal records

    • 4.2 Receiving and Storage of Hazardous Materials

    1. Material Receipt:
      1. Verify all hazardous material shipments against purchase orders for accuracy.
      2. Check for:
        • Proper labeling (GHS symbols, batch numbers)
        • Intact packaging without leaks or damage
        • Accompanying Safety Data Sheets (SDS)
      3. Document receipt details in the Material Receipt Log (Annexure 1).

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    2. Storage Requirements:
      1. Store hazardous materials in GMP-compliant storage areas equipped with:
        • Temperature and humidity controls
        • Ventilation systems
        • Secondary containment systems to control spills
      2. Label storage locations with hazard symbols and material information.
      3. Segregate materials by compatibility to prevent reactions.

    4.3 Handling Hazardous Materials

    1. Personnel Requirements:
      • Only trained and authorized personnel must handle hazardous materials.
      • Personnel must wear appropriate GMP-compliant PPE, including:
        • Gloves
        • Goggles or face shields
        • Respirators (if necessary)
        • Protective suits

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    2. Handling Procedures:
      1. Use calibrated equipment (e.g., pumps, scales) to transfer hazardous materials safely.
      2. Follow GMP procedures for measuring, dispensing, and mixing hazardous chemicals.
      3. Prevent cross-contamination by cleaning tools and equipment after each use.
    3. Documentation:
      • Record each handling activity in the Hazardous Material Handling Log (Annexure 2).
      • Document deviations, incidents, or spills as per GMP protocols.

    4.4 Disposal of Hazardous Materials

    1. Waste Segregation and Labeling:
      • Segregate hazardous waste by type: flammable, corrosive, toxic, or reactive.
      • Label waste containers with:
        • Material name
        • Hazard class
        • Disposal date

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    2. Disposal Process:
      1. Use approved vendors for hazardous waste collection and disposal.
      2. Document disposal activities in the Hazardous Waste Disposal Log (Annexure 3).
      3. Retain waste manifests for audit purposes.

    4.5 Inspection and Audits

    1. Internal Inspections:
      • Conduct weekly GMP inspections of hazardous material storage and handling areas.
      • Document findings and corrective actions in the Inspection Log (Annexure 4).

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    2. External Audits:
      • Schedule annual third-party GMP audits to verify compliance.
      • Address non-conformities and update processes accordingly.

    4.6 Training and Documentation

    1. Training Requirements:
      • Train personnel on GMP principles, hazardous material handling, and emergency procedures.
      • Maintain training records and ensure annual refresher sessions.

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    2. Documentation:
      • Ensure all records related to hazardous material handling comply with GMP standards.
      • Retain records for a minimum of five years for audit purposes.

    5) Abbreviations, if any

    • GMP: Good Manufacturing Practices
    • SDS: Safety Data Sheet
    • PPE: Personal Protective Equipment

    6) Documents, if any

    • Material Receipt Log
    • Hazardous Material Handling Log
    • Hazardous Waste Disposal Log
    • Inspection Log

    7) Reference, if any

    • GMP Guidelines (ICH Q7)
    • OSHA Hazard Communication Standard (29 CFR 1910.1200)
    • EPA Hazardous Waste Management Guidelines

    8) SOP Version

    Version: 1.0

    Annexure

    Template 1: Material Receipt Log

     
     
     Date Material Name Batch Number Supplier Quantity Inspected By

    Template 2: Hazardous Material Handling Log

     
     
     Date Material Name Quantity Used Location Handled By Remarks
    See also  SOP for Handling Gas Leaks in Pharmaceutical Plants