Monday, May 22, 2017
Project co-funded by the European Commission in the framework of the 2nd Health Programme
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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
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