Re: Would ANVISA (Brazil) inspection our new manufacturing site?
Yes, you do. The GMp certificate is only valid to the plant where the inspection ocurred.
My question is close to the original from Karen12.
My company is planning to outsource the production of a couple of mature products to the manufacturing company has been providing us with the "basic unit" of the system for years, that is all the hardware (rack of boards and mechanical parts and plastic covers) with the exception of the display.
Today we receive the basic unit, add the monitor and perform final testing, including safety test, label the product, configure for the customer (licensing) and ship.
This process passed the GMP inspection of ANVISA.
According to the plan, in the future in our factory we only would label the product, configure for the customer and ship.
My company will still be the legal manufacturer. Do you think we can keep the registration of our factory as the "manufacturing location"?
In case we have to submit the process again to ANVISA, would an ANVISA inspector accept to verify that we keep complete control of the manufacturing at our subcontractor or he would ask to inspect the subcontractor as well?
Thanks.
Max.