ISO 13485 and European GMP

[lewisking34]

Hi All!

I was wondering if anyone has experience working within an ISO13485 and European GMP environment simultaneously?

I work in a European GMP certified Pharma company and I'm looking into what it would take to become a Medical Device Manufacturer. I've never heard of a Medical Device company using GMP to drive their quality system instead of ISO13485, therefore I suspect becoming ISO13485 certified would be the most suitable route for me to achieve the my objective - any thoughts on this?

Does anyone have experience on implementing ISO13485 into a well established GMP compliant Quality system, can they be successfully integrated and what were the complications?

Thanks,
Lewis

 

[Ronen E]

Hi All!

I was wondering if anyone has experience working within an ISO13485 and European GMP environment simultaneously?

I work in a European GMP certified Pharma company and I'm looking into what it would take to become a Medical Device Manufacturer. I've never heard of a Medical Device company using GMP to drive their quality system instead of ISO13485, therefore I suspect becoming ISO13485 certified would be the most suitable route for me to achieve the my objective - any thoughts on this?

Does anyone have experience on implementing ISO13485 into a well established GMP compliant Quality system, can they be successfully integrated and what were the complications?

Thanks,
Lewis

I once worked for a pharmaceuticals manufacturer that also made formulated devices. That manufacturer had a QMS based on ICH guidelines (GMP), ISO 13485 and ISO 9001 certified. So it can be done. I believe they went through the same process as you've described because it was initially a pharma company and the devices side was introduced later. I can't tell you what the complications were because the system was established long before I arrived and it was functioning reasonably. It also wasn't the focus of my involvement there.

Yes, I think that ISO 13485 is the way to go for an EU-based medical devices manufacturer.

 

[AndretN]

I cannot see how any company can run two QMS's, thus integration based on the process approach is the only answer

 

[twanmul]

You can have one QMS but two different procedures for management of processes within that QMS (.e.g. risk). You can therefore have one risk management procedure that is compliant/more aligned (Risk Management Procedure for Pharmaceuticals/ATMP's) with ICH part 9 and another that is compliant (Risk Management Procedure for Medical Devices) with ISO14971. They should feed into the same quality system, but you treat them as procedures for different types of products (which they are).