Hi All,
I have been working in biopharmaceutical industry equipment validation sides from past many years and currently working on the project on combination product, medical device.
I do understand that we have to do qualification (IOQ. PQ) of the equipment used for manufacturing of the medical device, however from the CFR 820, it is not clear if the same is applicable for the lab equipment/instrument used to test the final product (syringe with the product). Please let me know if you are aware of guidance I should follow and if I should be doing IQ, OQ and PQ of the lab equipment as well with rationale.
Waiting for your expert response.
Thanks,
Jayen