Page 16 - Quality control of pharmaceuticals (07-PA 704)
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After modification
To ensure that the instrument continues to operate satisfactorily.
4. Performance Qualification (PQ)
PQ is the documented collection of activities to demonstrate that :
1) The instrument continues to perform satisfactorily according to user
specifications.
2) The instrument is appropriate for intended use.
PQ testing is repeated daily, weekly, monthly, yearly or whenever the
instrument is being used.
Frequency of Performance Qualification > Frequency of Operational
Qualification
Qualification of HPLC Chromatograph
The chomatograph consists essentially of 4 main parts, the pump, injector,
oven and detector.
Specifications of HPLC:
Peak area
Retention time
