ANVISA Inspection / Audit - French Company - China Manufacturing - Brazil Distributor

N

noedum

#1
Good morning,

Our distributor informed us that ANVISA planned an inspection for our company.

1) We are French "manufacturer" according European directive but we subcontract the manufacturing to a Chinese factory.
I could understand that this inspection is a Br-GMP inspection of the manufacturing site/factory. In our context, which company ANVISA will more probably inspect : our company in France (we are only offices: The activities are design and development, marketing, sales and after-sales service) or the Chinese factory ( which manufactures and tests the devices)?
It could cause some problems because we doesn't want to divulgate the name of the chinese factory to our Brazilian distributor.

2) One of our Brazilian contact told us that there is a list of companies planned to be inspected on ANVISA website. But I check the website and I'm not be able to find it.
Does somebody knows how to find this information on ANVISA website or have the web link?

Thank you for the answers,
BR
 
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Marcelo

Inactive Registered Visitor
#2
Re: ANVISA Inspection / Audit - French Company - China Manufacturing - Brazil Distrib

1)
In our context, which company ANVISA will more probably inspect : our company in France (we are only offices: The activities are design and development, marketing, sales and after-sales service) or the Chinese factory ( which manufactures and tests the devices)?
The chinese factory. It´s a good manufacturing practice, not good office practice, after all :) Just kidding, anyway , one of the focus of Anvisa is in inspctiing the real manufacturing site, not distributor or office.


2) One of our Brazilian contact told us that there is a list of companies planned to be inspected on ANVISA website. But I check the website and I'm not be able to find it.
Does somebody knows how to find this information on ANVISA website or have the web link?

Anvisa B-GMP inspection plans
 
Last edited:
M

MIREGMGR

#3
Re: ANVISA Inspection / Audit - French Company - China Manufacturing - Brazil Distrib

It could cause some problems because we doesn't want to divulgate the name of the chinese factory to our Brazilian distributor.
What is ANVISA's stated policy regarding protection of such proprietary information, and how does it work in actual practice?
 

Marcelo

Inactive Registered Visitor
#4
Re: ANVISA Inspection / Audit - French Company - China Manufacturing - Brazil Distrib

Quote:
Originally Posted by noedum

It could cause some problems because we doesn't want to divulgate the name of the chinese factory to our Brazilian distributor.

What is ANVISA's stated policy regarding protection of such proprietary information, and how does it work in actual practice?
The arrangements have to be done thru the registration holder because he is the "manufacturer" in the eyes of Anvisa. So he will have to know the inspection site. If the distributor is the registration holder, he wil know.

Please note that "proprietary information" does not apply very well in this case.
 
M

MIREGMGR

#5
Re: ANVISA Inspection / Audit - French Company - China Manufacturing - Brazil Distrib

The arrangements have to be done thru the registration holder because he is the "manufacturer" in the eyes of Anvisa. So he will have to know the inspection site. If the distributor is the registration holder, he wil know.

Please note that "proprietary information" does not apply very well in this case.
Yikes...
 
N

noedum

#6
Re: ANVISA Inspection / Audit - French Company - China Manufacturing - Brazil Distrib

1)

The chinese factory. It´s a good manufacturing practice, not good office practice, after all :) Just kidding, anyway , one of the focus of Anvisa is in inspectiing the real manufacturing site, not distributor or office.

Dear Mr Mantunes

Thank you for your answer and the helpfull link.
That it means that ANVISA would like to inspect the factory even if it is another company than our company and the product is labelled with our company as we are the LEGAL manufacturer. Is it right?

In term of Br-GMP:
Does it mean that our company must implement BR-GMP and also the factory? Or it is just needed for the factory or for just for our company?

For the BR-GMP implementation, we are already ISO 13485, 9001 and we are trying with a consultant to implement US GMPs requirements (21 CFR part 820). The factory is ISO 13485 and have a 510k so probably implement the applicable QSR parts. In this context, it is necessary to contract with a consultant to implement Br-GMP or not?
Is it necessary to do something to prepare the ANVISA inspection according that we have ISO 13485+ ISO 9001 + US GMPs?

I would like to try to implement BR-GMP in our Quality System but I don't know where to find the additional Brazilian requirements in English and how to proceed.
I'm sorry for all this questions. But it is the first time for Brazil market.

Thank you in advance,
Best regards,
 
R

recruit

#7
Re: ANVISA Inspection / Audit - French Company - China Manufacturing - Brazil Distrib

1)

The chinese factory. It´s a good manufacturing practice, not good office practice, after all :) Just kidding, anyway , one of the focus of Anvisa is in inspctiing the real manufacturing site, not distributor or office.


2) One of our Brazilian contact told us that there is a list of companies planned to be inspected on ANVISA website. But I check the website and I'm not be able to find it.
Does somebody knows how to find this information on ANVISA website or have the web link?

Anvisa B-GMP inspection plans
Hi Marcelo, our factory had been inspected by ANVISA. In my experience, the GMP inspection covers design&developement, marketing sale and after -sales service, just like QSR. You can refer to RDC 59. So in the case, the French office needs to be auditted too. How do you think?
 

Marcelo

Inactive Registered Visitor
#8
Re: ANVISA Inspection / Audit - French Company - China Manufacturing - Brazil Distrib

Hi Marcelo, our factory had been inspected by ANVISA. In my experience, the GMP inspection covers design&developement, marketing sale and after -sales service, just like QSR. You can refer to RDC 59. So in the case, the French office needs to be auditted too. How do you think?
hello, you are right, RDC 59 does cover all these, as it´s a copy of the QSR..but th OP asked what would probably be more expected to be audited, and it´s is the factory, not the offices, although the offices would still be audited too if the was the case.

When i answered, i though (although not explicitly saying it) about a situation in which Anvisa would need to chosse (for example, due to budget concerns), so they would choosse the factory, which holds the "main" part of the manufacturing process.

But you are right, the offices would still be "inspectable too", and so they might inspect both. But as i said, the new focus of Anvisa is in inspectiing the real manufacturing site, not distributor or office. Note that in the past Anvisa would only inspect the offices and everything could be ok.
 
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