Permit for the Operation of a Laboratory for Processing Cells and Stem Cells for Clinical Applications in a Hospital

UMKU PB Details

Parameters:

  • All

Authority:

  • Minister/Head of Agency

Requirements

  1. Organization

    2. Duration: -

  2. Documents for hospital business licensing

    3. Duration: -

  3. Documents listing stem cell processing equipment and supporting equipment

    4. Duration: -

  4. Documents listing human resources

    5. Duration: -

  5. Documents for the establishment of a Stem Cell Processing Laboratory unit in the hospital

    6. Duration: -

  6. Documents for the profile of the Stem Cell Processing Laboratory

    7. Duration: -

  7. Format for ASSESSMENT OF STEM CELL PROCESSING LABORATORY FOR CLINICAL APPLICATION IN HOSPITALS

    8. Duration: -

  8. Documents listing facilities, infrastructure, and procedures to ensure:
    • Quality of processing and products
    • Health and safety of personnel and handling, both for biological agents and hazardous materials (B3), and their surrounding environment
    • Control and handling of medical waste generated, excluding transportation, processing, and disposal
    • Source materials are preserved and safe in accordance with requirements, and source materials are safe for laboratory personnel and the environment
    • Environmental conditions, water, air, and electricity supply to ensure the quality of processing and products

    Duration: -

Renewal Requirements:

  • Documents for standard certification
  • Documents for a statement of replacement of hospital location signed by the hospital head/director

Duration: -

Responsibilities

  1. Dialysis service standards

    2. Duration: -

  2. Reporting/registration of services

    3. Duration: -

Sector: Health
Status: Available
Belongs to:
86101
86103
86105
86903

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