PQ of eye drop filling machine

GOOD DOCUMENTATION PRACTICE (GDocP) PQ (PERFORMANCE QUALIFICATION)
1

Dear brothers/sisters,
I want to know the test parameters and acceptance criteria of automatic eye drop filling machine to execute PQ.
It will be helped for me to share any reference also.

2

The things that come to my mind immediately are:

  • Does the system operate as required over the duration of the PQ
  • Is the product unaffected for the duration of the PQ

Other than your basic quality parameters, a good source of tests could be defined in your process FMEA.

3

Hi,
We also have eye drop filling machine, and we perform it’s PQ.We measure the quantity of liquid in eye drop vial.It must conform to acceptance criteria at the starting, middle part end ending part of filling.
Best Regards.