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
- Organization
- Documents for hospital business licensing
- Documents listing stem cell processing equipment and supporting equipment
- Documents listing human resources
- Documents for the establishment of a Stem Cell Processing Laboratory unit in the hospital
- Documents for the profile of the Stem Cell Processing Laboratory
- Format for ASSESSMENT OF STEM CELL PROCESSING LABORATORY FOR CLINICAL APPLICATION IN HOSPITALS
- 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: -
Duration: -
Duration: -
Duration: -
Duration: -
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Renewal Requirements:
- Documents for standard certification
- Documents for a statement of replacement of hospital location signed by the hospital head/director
Duration: -
Responsibilities
- Dialysis service standards
- Reporting/registration of services
Duration: -
Duration: -
Sector: Health
Status: Available
Belongs to:
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