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SOP for Cleaning and Sanitization of Storage Facilities

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Standard Operating Procedure for Cleaning and Sanitization of Storage Facilities

Purpose

The purpose of this SOP is to establish procedures for the cleaning and sanitization of storage facilities within the pharmaceutical distribution facility, ensuring compliance with regulatory requirements and Good Distribution Practice (GDP) guidelines to maintain product integrity and safety.

Scope

This SOP applies to all personnel involved in cleaning and sanitization activities within storage facilities, including warehouse staff, janitorial personnel, and contractors.

Responsibilities

  • The Facilities Management Team is responsible for coordinating and overseeing cleaning and sanitization activities within storage facilities.
  • The Warehouse Supervisor is responsible for ensuring that cleaning schedules are followed and that cleaning tasks are performed effectively.
  • All personnel are responsible for adhering to cleaning and sanitization procedures and reporting any issues or concerns to the Facilities Management Team.
See also  SOP for Transportation Validation

Procedure

  1. Preparation for Cleaning:
    • Clear storage areas of products, materials, and equipment to facilitate thorough cleaning.
    • Ensure that cleaning personnel have access to appropriate cleaning supplies, equipment, and personal protective equipment (PPE).
  2. Cleaning Process:
    • Remove debris, dust, and other visible contaminants from storage surfaces using dry cleaning methods, such as sweeping or vacuuming.
    • Apply suitable cleaning agents or disinfectants to surfaces using approved methods, such as spraying, mopping, or wiping.
    • Focus on high-touch surfaces, shelving, floors, walls, and other areas prone to contamination.
  3. Rinsing and
Drying:
  • Rinse cleaned surfaces thoroughly with clean water to remove any residue from cleaning agents or disinfectants.
  • Allow surfaces to air dry completely before reintroducing products or materials into the storage area.
  • Verification and Inspection:
    • Inspect cleaned areas to ensure that all surfaces are visibly clean and free from contamination.
    • Verify the effectiveness of cleaning and sanitization procedures through environmental monitoring, if applicable.
  • Documentation:
    • Maintain detailed records of cleaning activities, including cleaning schedules, cleaning agents used, and inspection results.
    • Document any deviations or issues encountered during the cleaning process and the actions taken to address them.
  • Review and Continuous Improvement:
    • Review cleaning and sanitization procedures regularly to ensure effectiveness and compliance with regulatory requirements.
    • Implement any necessary improvements or corrective actions identified through audits, inspections, or feedback.
  • Abbreviations

    • GDP – Good Distribution Practice
    • PPE – Personal Protective Equipment

    Documents

    Reference documents related to cleaning and sanitization may include:

    • Cleaning schedules
    • Cleaning agent specifications
    • Cleaning validation reports
    • Inspection records
    • Corrective action reports

    Reference

    Good Distribution Practice Guidelines

    SOP Version

    Version 1.0

    See also  Good Distribution Practice: SOP for Cold Chain Management
    Good Distribution Practice Tags:Cold chain management, Controlled drug handling regulations, Distribution logistics, Distribution quality control, Distribution quality management, GDP audit, GDP certification, GDP compliance, GDP guidelines, GDP regulations, GDP training, Good Distribution Practice SOPs, Good Distribution Practice training, Pharmaceutical distribution, Pharmaceutical distribution standards, Pharmaceutical logistics, Pharmaceutical supply chain, Regulatory compliance in distribution, Storage conditions monitoring, Temperature mapping, Temperature-controlled logistics, Transportation validation, Warehousing best practices

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    Standard Operating Procedures V 1.0

    • Aerosols
    • Analytical Method Development
    • Bioequivalence Bioavailability Study
    • Capsule Formulation
    • Clinical Studies
    • Creams
    • Data Integrity
    • Dental Dosage Forms
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    • Quality Assurance
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    • Raw Material Stores
    • Regulatory Affairs
    • Tablet Manufacturing
    • Rectal Dosage Forms
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    • Vaginal Dosage Forms
    • Validations and Qualifications

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    NEW! Revised SOPs – V 2.0

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