Would ANVISA (Brazil) inspect our new manufacturing site?

K

karen12

#1
Hello everyone,

Our company has moved to a new location and I am wondering if we(manufacturer) need to go through GMP inspection by ANVISA on new manufacturing site?

Thanks in advance for your answer.
 
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Stijloor

Staff member
Super Moderator
#2
Re: Would ANVISA (Brazil) inspection our new manufacturing site?

A Quick Bump!

Can someone help Karen?

Thank you very much!!
 
G

Gert Sorensen

#3
Re: Would ANVISA (Brazil) inspection our new manufacturing site?

Could you elaborate a bit on the move. From where to where?
 
K

karen12

#4
Re: Would ANVISA (Brazil) inspection our new manufacturing site?

from A city to B city but in same country.
 

Marcelo

Inactive Registered Visitor
#5
Re: Would ANVISA (Brazil) inspection our new manufacturing site?

Our company has moved to a new location and I am wondering if we(manufacturer) need to go through GMP inspection by ANVISA on new manufacturing site?
Yes, you do. The GMp certificate is only valid to the plant where the inspection ocurred.
 
D

deuce64

#6
Re: Would ANVISA (Brazil) inspection our new manufacturing site?

Marcelo,
Hoping you might know answer here:
Our company recently had a successful Anvisa Audit. it was originally requested by our distributor in brazil with whom we have a good relationship. in the future though, we would like to have our registrations of new products hosted by a third party. how can we leveradge the recent Anvisa Audit with our new host so that we don't have to undergo another audit?

thanks
 

Marcelo

Inactive Registered Visitor
#7
Re: Would ANVISA (Brazil) inspection our new manufacturing site?

Our company recently had a successful Anvisa Audit. it was originally requested by our distributor in brazil with whom we have a good relationship. in the future though, we would like to have our registrations of new products hosted by a third party. how can we leveradge the recent Anvisa Audit with our new host so that we don't have to undergo another audit?

Formally, you can?t. But then requesting a new inspection (paying the fee too), you can mention that it was already inspected, so when to time comes for inspection, ANVISA will probably not go there.
 

max.polix

Involved In Discussions
#8
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.
 

Marcelo

Inactive Registered Visitor
#9
Re: Would ANVISA (Brazil) inspection our new manufacturing site?

My company will still be the legal manufacturer. Do you think we can keep the registration of our factory as the "manufacturing location"?
No. The manufacturing will be performed in another location as you described.

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?
Probably not, because he would do the majority of the manufacturing process, so he should be inspected.
 

max.polix

Involved In Discussions
#10
Re: Would ANVISA (Brazil) inspection our new manufacturing site?

This means we have to submit again for the Anvisa GMP and the product registration, stopping shipment to Brazil until received the new registration?
Or we are allowed to make the change and just inform Anvisa?
 
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