We're trying to land some business in Venezuala and the government is asking for "GMP Certification". My research shows that pharmaceutical manufacturers have a route to obtain GMP Certification (similar to paying an ISO registrar) but I haven't found anything pertaining to medical device manufacturers. Have any of you had any experience with Venezuala or Medical Device GMP Certifications?

I'm trying to figure out what to tell my boss. :confused:

:thanks:

We're trying to land some business in Venezuala and the government is asking for "GMP Certification". My research shows that pharmaceutical manufacturers have a route to obtain GMP Certification (similar to paying an ISO registrar) but I haven't found anything pertaining to medical device manufacturers. Have any of you had any experience with Venezuala or Medical Device GMP Certifications?

I'm trying to figure out what to tell my boss. :confused:

:thanks:They may be asking for your approval letter from FDA.

We're trying to land some business in Venezuala and the government is asking for "GMP Certification". My research shows that pharmaceutical manufacturers have a route to obtain GMP Certification (similar to paying an ISO registrar) but I haven't found anything pertaining to medical device manufacturers. Have any of you had any experience with Venezuala or Medical Device GMP Certifications?

I'm trying to figure out what to tell my boss. :confused:

:thanks:

When in doubt about the requirements, ask the (potential) customer. They probably have the best information about satisfying their own government's requirements.

Perhaps by "GMP certification" they mean FDA registration for the medical device regs 21 CFR parts 800-1299? Perhaps that is acceptable.

Or do they have their own GMPs that you have to register to or have a third party audit to?

Best bet is to contact the customer directly.

Hi

I suspect they want a "Certificate for Foreign Government" which says your devices are being legally marketed in USA. Have a look at: http://www.fda.gov/cdrh/devadvice/39.html for more information.

I understand GMP as being Good Manufacturing Process.... check this FDA link : http://www.fda.gov/cdrh/comp/gmp.html

We're trying to land some business in Venezuala and the government is asking for "GMP Certification". My research shows that pharmaceutical manufacturers have a route to obtain GMP Certification (similar to paying an ISO registrar) but I haven't found anything pertaining to medical device manufacturers. Have any of you had any experience with Venezuala or Medical Device GMP Certifications?

I'm trying to figure out what to tell my boss. :confused:

:thanks:

I think the GMP Certificate is only issued in case of Pharmaceuticals but in case of devices, TGA (Therapeutic Goods Administration) of Australia have a form for Quality System Certificate. Refer this link - http://www.tga.gov.au/docs/html/forms/gmpcert.htm

The request form is available http://www.tga.gov.au/docs/pdf/forms/gmpcert.pdf

Are you referring to this ?

We're trying to land some business in Venezuala and the government is asking for "GMP Certification". My research shows that pharmaceutical manufacturers have a route to obtain GMP Certification (similar to paying an ISO registrar) but I haven't found anything pertaining to medical device manufacturers. Have any of you had any experience with Venezuala or Medical Device GMP Certifications?

I'm trying to figure out what to tell my boss. :confused:

:thanks:


GMP in the USA gernerally refers to "Good Manufacturing Practices," put out by the US FDA. The reference copy I have says
Code of Federal Regulations -
Title 21, Volume 4
Revised as of April 1, 2005
CITE: 21CFR211

It is commonly used by companies in the Food and Drug industries. My client made containers used by some pharmaceutical companies. However, to my knowledge, it is not certified by a 3rd party registrar. My client had customers come to audit and verify compliance. Thus, there was no "certificate," just an audit report and or findings. The certification they carried was to ISO 9001, which has similar requirements.