ISO 9001 vs. ISO 13485 - Which standard for pharmaceutical medicinal product

[mwa]

hi All ,


What kind of quality management system certification require to manufacture a pharmaceutical medicinal product. Is it ISO9001?

If a company has a ISO 13485 for the medical device . can he use this certification in order to get the manufacturing license for medicinal product (Drug)

Thanks

 

[Chris Ford]

hi All ,


What kind of quality management system certification require to manufacture a pharmaceutical medicinal product. Is it ISO9001?

If a company has a ISO 13485 for the medical device . can he use this certification in order to get the manufacturing license for medicinal product (Drug)

Thanks

The directives, ordinances and laws vary between countries. You need to look at the particular country's requirements for licensing. Check with the health ministry in that country.

 

[SteveK]

Quick answer to last question – no! You need a Product Licence (as Chris alludes to).
First question – from my experience in Pharma, quality systems go the way of GMP (e.g. Orange Book) – not ISO 9001.

 

[Chris Ford]

Quick answer to last question – no! You need a Product Licence (as Chris alludes to).
First question – from my experience in Pharma, quality systems go the way of GMP (e.g. Orange Book) – not ISO 9001.

But he's in Germany, and didn't say anything about manufacturing or distributing here in the US. I don't believe a quality management system standard specific to the pharma industry exists, though. At any rate, requirements between countries vary, so it's impossible to answer the question. Where ever it is, it'll probably be subject to some kind of evaluation and approval process, and they'll probably have some sort of quality system requirement.

 

[Ajit Basrur]

hi All ,


What kind of quality management system certification require to manufacture a pharmaceutical medicinal product. Is it ISO9001?

If a company has a ISO 13485 for the medical device . can he use this certification in order to get the manufacturing license for medicinal product (Drug)

Thanks

For Pharmaceuticals, none of the ISO 9001 / 13485 could be useful - 9001 is for general quality management systems while 13485 addresses the QMS for medical devices.

For Pharmaceutical products, you should be adopting the GMP standards. For Europe, refer http://ec.europa.eu/enterprise/pharmaceuticals/pharmacos/gmp_doc.htm

 

[SteveK]

But he's in Germany, and didn't say anything about manufacturing or distributing here in the US. I don't believe a quality management system standard specific to the pharma industry exists, though. At any rate, requirements between countries vary, so it's impossible to answer the question. Where ever it is, it'll probably be subject to some kind of evaluation and approval process, and they'll probably have some sort of quality system requirement.

I was only giving an example of a GMP (cGMP) guide that I know (i.e. Orange Book!) – and yes a great deal of evaluation is required - Phase I to Phase III (and IV) clinical trials, Drug Master Files produced, finished drugs released by QP etc. The Product Licence (UK), or more strictly for the EU – Marketing Authorisation (with PL or EU number) then follows.

Steve