Wednesday, June 28, 2017
Project co-funded by the European Commission in the framework of the 2nd Health Programme
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6. VALIDATION

  • 6.1 Validation
    • 6.1.1 Validation Master Plan
    • 6.1.2 Protocol
    • 6.1.3 Report
    • 6.1.4 Equipment qualification
    • 6.1.5 Clean Rooms and Laminar Flow Hoods Qualification
    • 6.1.6 Process validation
    • 6.1.7 Prospective validation
    • 6.1.8 Concurrent validation
    • 6.1.9 Retrospective validation
    • 6.1.10 Cleaning and Disinfection Validation
    • 6.1.11 Validation of Analytical Methods
    • 6.1.12 Revalidation
  • 6.2 Example of Transport validation
    • 6.2.1 Objective
    • 6.2.2 Scope
    • 6.2.3 Responsibilities
    • 6.2.4 Related documents
    • 6.2.5 Critical validation elements
    • 6.2.6 Method to perform the study
    • 6.2.7 Results and acceptance criteria
    • 6.2.8 Conclusions
  • 6.3: Facilities disinfection
    • 6.3.1. Objective
    • 6.3.2. Scope
    • 6.3.3. Responsibilities
    • 6.3.4. Related documents
    • 6.3.5. Critical validation elements
    • 6.3.6. Method to perform the study
    • 6.3.7. Results and acceptance criteria
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