23-06-2012, 05:18 PM
GMP Manufacturing Environments
GMP Manufacturing Environments.ppt (Size: 732 KB / Downloads: 206)
Qualification of HVAC Systems
Definition of Validation :
The documented act of proving that any procedure, process, equipment, material, activity or system, actually leads to the expected results.
PIC/S Definition of Validation :
Action of proving, in accordance with the principles of Good Manufacturing Practice, that any procedure, process, equipment, material, activity or system actually leads to the expected results.
Validation or Qualification of a HVAC System ?
A system must be qualified to operate in a validated process
Equipment and systems are qualified
A process is validated
A number of systems make up a process
Critical Components
A critical component within a system where the operation, contact, data, control, alarm or failure will have a direct impact on the quality of the product.
Eg. Supply air fan in an AHU, HEPA filters, HVAC control system.
Non-critical Components
A non-critical component within a system where the operation, contact, data, control, alarm or failure will have an in-direct, or no impact on the quality of the product.
Eg. Main facility chiller, Eskom high tension transformer on site.