Friday, July 21, 2017
Project co-funded by the European Commission in the framework of the 2nd Health Programme
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A: GENERAL REQUIREMENTS

  • A.1. PERSONNEL
  • A.2. FACILITIES AND EQUIPMENT
    • A.2.1. FACILITIES, EQUIPMENT AND MATERIALS FOR RECOVERY
      • A.2.1.1. Facilities
        • A.2.1.1.1. General
        • A.2.1.1.2. Operating room
        • A.2.1.1.3. Unusual place of recovery
        • A.2.1.1.4. Ancillary areas
      • A.2.1.2. Equipment
      • A.2.1.3. Materials
      • A.2.1.4. Safety and Environment
    • A.2.2. FACILITIES, EQUIPMENT AND MATERIALS FOR PROCESSING
      • A.2.2.1. Facilities
        • A.2.2.1.1. General
        • A.2.2.1.2. Processing area
        • A.2.2.1.3. Environmental airborne control
        • A.2.2.1.4. Environmental microbiological control
        • A.2.2.1.5. Sanitation
        • A.2.2.1.6. Isolator technology
        • A.2.2.1.7. Ancillary areas
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      • A.2.2.2. Equipment
        • A.2.2.3. Materials
          • A.2.2.3.1. General
          • A.2.2.3.2. Material requirements
        • A.2.2.4. Safety and Environment
      • A.2.3. FACILITIES, EQUIPMENT AND MATERIALS FOR STORING
    • A.3. DONOR SCREENING
      • A.3.1. ACTIVITIES
        • A.3.1.1. Donor detection
          • A.3.1.1.1. Determination of death
          • A.3.1.1.2. Donor identification
          • A.3.1.1.3. Post Morten donor maintenance
        • A.3.1.2. Donor consent; judicial and familiar
          • A.3.1.2.1. Deceased donor
          • A.3.1.2.2. Living donor
        • A.3.1.3. Data protection and confidentiality
        • A.3.1.4. Advertising
        • A.3.1.5. Prohibition of financial compensation for donors
        • A.3.1.6. Donor evaluation; medical, social and physical
          • A.3.1.6.1. General
          • A.3.1.6.2. Medical and social evaluation
          • A.3.1.6.3. Physical evaluation of cadaveric donors
          • A.3.1.6.4. Exclusion criteria
          • A.3.1.6.5.1. Deceased donor
          • A.3.1.6.5.2. Additional exclusion criteria for dead children donors
          • A.3.1.6.5.3. Living donors
            • A.3.1.6.5.3.1. Allogeneic use donation
            • A.3.1.6.5.3.2. Autologous use donation
            • A.3.1.6.6. Autopsy
        • A.3.1.7. Donor evaluation; biological
          • A.3.1.7.1. General
          • A.3.1.7.2. Allogeneic Donation
            • A.3.1.7.2.1. Heart beating donors
            • A.3.1.7.2.2. Non‐heart beating donors (Post‐mortem removal)
            • A.3.1.7.2.3. Living donors
          • A.3.1.7.3. Autologous Donations
          • A.3.1.7.4. Serum Bank
        • A.3.1.8. Documentation and release for recovery
          • A.3.1.8.1. General
          • A.3.1.8.2. Release
          • A.3.1.8.3. Donor Screening File Contents
        • A.3.1.9. Availability for inspection
        • A.3.1.10. Traceability
    • A.4. RECOVERY
      • A.4.1. ACTIVITIES
        • A.4.1.1. Access to the operating room
        • A.4.1.2. Access to an unusual place of recovery
        • A.4.1.3. Recovery
          • A.4.1.3.1. General
          • A.4.1.3.2. Deceased donors
            • A.4.1.3.2.1. Recovery procedure of tissues
            • A.4.1.2.3.2. Reconstruction of the donor's body
          • A.4.1.3.3. Living donors
        • A.4.1.4. Processing during recovery
        • A.4.1.5. Packaging and labelling
          • A.4.1.5.1. Primary packaging and labelling operation
          • A.4.1.5.2. Secondary packaging and labelling operation
        • A.4.1.6. Storage and transport
          • A.4.1.6.1. Storage
          • A.4.1.6.2. Transport
        • A.4.1.7. Documentation and release for processing
          • A.4.1.7.1. General
          • A.4.1.7.2. Release
          • A.4.1.7.3. Recovery File Contents
          • A.4.1.7.4. Availability for inspection
          • A.4.1.7.5. Traceability
    • A.5. PROCESSING
      • A.5.1. ACTIVITIES
        • A.5.1.1. Reception
          • A.5.1.1.1. Receipt of tissues and cells at processing centre
          • A.5.1.1.2. Verification of tissues received
          • A.5.1.1.3. Identification of tissues and cells
        • A.5.1.2. Access to the processing facilities
        • A.5.1.3. Processing
          • A.5.1.3.1. General
          • A.5.1.3.2. Processing methods
          • A.5.1.3.3. Cross contamination
        • A.5.1.4. Quality Control
          • A.5.1.4.1. Microbiological control
            • A.5.1.4.1.1. General Principle
            • A.5.1.4.1.2. Microbiological controls
        • A.5.1.5. Packaging and labelling
          • A.5.1.5.1. Packaging and labelling materials management
          • A.5.1.5.2. Primary packaging and labelling operation
          • A.5.1.5.3. Secondary packaging and labelling operation
        • A.5.1.6. Documentation and release in distribution
          • A.5.1.6.1. General
          • A.5.1.6.2. Release
          • A.5.1.6.3. Processing File Contents
          • A.5.1.6.4. Availability for inspection
          • A.5.1.6.5. Traceability
    • A.6. STORAGE AND DISTRIBUTION
      • A.6.1. GENERAL
      • A.6.2. DISTRIBUTION
      • A.6.3. IMPORT AND EXPORT
      • A.6.4. DOCUMENTATION AND RELEASE A.
        • 6.4.1. General
        • A.6.4.2. Release
        • A.6.4.3. Storing and Distribution File Contents
        • A.6.4.4. Availability for inspection
        • A.6.4.5. Traceability
    • A.7. QUALITY MANAGEMENT
      • A.7.1. QUALITY ASSURANCE
        • A.7.1.1. General
        • A.7.1.2. Documentation
        • A.7.1.3. Non‐compliance management
        • A.7.1.4. Internal Audit
        • A.7.1.5. Product Quality Review/Process Quality Review
          • A.7.1.5.1. Donor screening
          • A.7.1.5.2. Recovery
          • A.7.1.5.3. Processing
          • A.7.1.5.4. Distribution
        • A.7.1.6. Recalls
        • A.7.1.7. Complaints and returns
          • A.7.2. QUALITY CONTROL
            • A.7.2.1. General
            • A.7.2.2. Documentation
            • A.7.2.3. Sampling
            • A.7.2.4. Testing
            • A.7.2.5. Stability Monitoring
            • A.7.2.6. Expiry Date
          • A.7.3. QUALITY RISK MANAGEMENT
          • A.7.4. VALIDATION
            • A.7.4.1. General
            • A.7.4.2. Documentation
            • A.7.4.3. Facility, system and equipment qualification
              • A.7.4.3.1. Qualification for new facilities, systems and equipment
              • A.7.4.3.2. Qualification of established (in‐use) facilities, systems and equipment
              • A.7.4.3.3. Qualification of Clean Rooms
              • A.7.4.3.4. Qualification of Laminar Flow Hoods
            • A.7.4.4. Process validation
              • A.7.4.4.1. Prospective validation
              • A.7.4.4.2. Concurrent validation
              • A.7.4.4.3. Retrospective validation
            • A.7.4.5. Cleaning and Disinfection Validation
            • A.7.4.6. Revalidation
          • A.7.5. CRITICAL THIRD PARTY AGREEMENTS
          • A.7.6. CONTINUITY PLANS / CESSATION OF BANK
      • A.8. BIOVIGILANCE
        • A.8.1. SERIOUS ADVERSE EVENTS/REACTIONS
        • A.8.2. NOTIFICATION OF SERIOUS ADVERSE REACTIONS (RECIPIENTS)
        • A.8.3. NOTIFICATION OF SERIOUS ADVERSE REACTIONS (LIVING DONORS)
        • A.8.4. NOTIFICATION OF SERIOUS ADVERSE EVENTS

     

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