Qualification

Qualification:
Qualification is the act of planning , executing and recording of tests on equipment and instrument, which form part of the validated process, to demonstrate that it works correctly and leads to expected result .
Qualification


User Requirement Specification: A requirement specification that describe what the equipment or system is supposed to do , thus containing at lease a set of criteria or conditions that have to be met. URS comprises a broad set of requirement or Wish List that could be met in order to satisfy equipment or a utility need.
Design Qualification:The Initial phase of qualification in which specification and requirement in which specification and requirements are developed and established. Design qualification is documented evidence that the proposed design of the equipment and instrument are suitable for intended purpose.The compliance of the design with various standard like cGMP,Safety, etyc., shall be demonstrated and documented
FAT(Factory Acceptance Test) :Pre-delivery equipment testing designed to establish confidence that the equipment and ancillary system will meet functional requirements,and capable of consistent operation.Fat is performed at supplier site,and the results are used to release the equipment for shipment.


Qualification in Pharma 
HEPA Filter Integrity test 
HVAC Validation
Performance Qualification of Pharmaceutical Instruments 
Vendor Qualification
Performance Qualification of Vortex Mixture 
Performance Qualification of Air Born Particle Counter 
Performance Qualification of Laminar Air Flow
Performance Qualification of Hot Air Oven 
Performance Qualification of Heating Block 
Performance Qualification of Data Logger 
Performance Qualification of Double Door Autoclave 
Performance Qualification Colony Counter
Performance Qualification of BOD Incubator 
Performance Qualification of Crystal Panel Viewer 
Performance Qualification of Bacteriological Incubator 
Performance Qualification of Autoclave 
Performance Qualification of  Volumetric Air Sampler 
Analyst Qualification 


Comments


EmoticonEmoticon