Hi Experts,
I am looking for some guidance on the following question:
Current practice: We have the capacity to manufacture about 10 such diagnostic instruments per day. For most changes, this is how the validation is done. IQ (to ensure that the instrument can be assembled), OQ (to ensure that the instrument can be powered up) and PQ (to ensure that the instrument can pass the outgoing check). I think this current concept might be wrong. This is why I am writing in to you.
My question is: What should be the process validation (IQ, OQ, PQ) requirements for the manufacturing line I described?
Thank you in advance