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WHO Supplementary Training Modules: Validation, Water, Air Handling Systems - Validation (Part 2): Qualification of HVAC and Water Systems
(2006; 48 pages)
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View the documentSupplementary Training Modules on Good Manufacturing Practice
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View the documentSupplementary Training Modules on Good Manufacturing Practice
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View the documentWater for Pharmaceutical Use
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View the documentWater for Pharmaceutical Use
View the documentWater for Pharmaceutical Use
View the documentWater for Pharmaceutical Use
View the documentWater for Pharmaceutical Use
View the documentWater for Pharmaceutical Use
View the documentWater for Pharmaceutical Use
View the documentWater for Pharmaceutical Use
View the documentWater for Pharmaceutical Use
View the documentWater for Pharmaceutical Use
View the documentWater for Pharmaceutical Use
View the documentWater for Pharmaceutical Use
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View the documentValidation
 

HVAC

Qualification (2)

  • Described in a Validation Master Plan (VMP)

  • VMP to include the nature and extent of tests, and protocols

  • DQ, IQ, OQ, and PQ

  • Risk analysis to determine critical and non-critical parameters, components, subsystems and controls

8.2.2 The qualification of the HVAC system should be described in a validation master plan (VMP).

8.2.3 It should define the nature and extent of testing and the test procedures and protocols to be followed.

8.2.4 Stages of the qualification of the HVAC system should include DQ, IQ, OQ and PQ.

8.2.5 Critical and non-critical parameters should be determined by means of a risk analysis for all HVAC installation components, subsystems and controls.

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