Hi Andrew,

I like the examples you provided for IQ, OQ, PQ for prefilled syringes, but I think that the IQ for a Syringe filling line may be a little different. For example the Installation qualification may include the following:
– Manual and Technical documentation availability
– filler electrical requirements meets the available plug specifications
– Calibration and Preventative Mentainance schedule available.
– Alarms, interlocks, safety and ergonomics requirements are met and operational
– Operator interface/ Emergency stopping mechanism present and operational

Fady Khalla