J
Re: Process Qualification, Equipment Qualification, Operator Qualification - Sequence
Start with defining the intended purpose of your system/equipment.
Describe what process you need to serve with it.
Base your qualification on the critical process parameters and the applicable regulatory requirements (e.g. GMP).
This way you can prevent doing (test)work double or even triple like often happens in the conventional / sequientional IQ/OQ/PQ-block methodology.
Also you keep the focus on the process (where it matters) and not on insignifficant details like the pollishing grade of some nut or bolt (which has no product contact anyway...).
Just my
Start with defining the intended purpose of your system/equipment.
Describe what process you need to serve with it.
Base your qualification on the critical process parameters and the applicable regulatory requirements (e.g. GMP).
This way you can prevent doing (test)work double or even triple like often happens in the conventional / sequientional IQ/OQ/PQ-block methodology.
Also you keep the focus on the process (where it matters) and not on insignifficant details like the pollishing grade of some nut or bolt (which has no product contact anyway...).
Just my
