ISO 13485 vs. GMP - Comparison matrix wanted

[orleanna]

Hello everybody! I am working in the pharmaceutical industry and I am looking into the ISO 13485 standard. I know there are plenty of cases in Europe when the manufacturer of said pharmaceuticals starts all of the sudden producing medical devices. I was wondering if anyone might have a comparison matrix for those or some other type of resource that would outline their differences and similarities as I am only getting into researching the ISO 13485 and I am seeing lots of similarities between the two that make me confused of how the things are actually working as I am getting trouble on distinguishing the standart conformity and the regulatory compliance.
Thank you!

 

[AndretN]

I am looking for references where a company manufacturing both medicines and medical devices integrated GMP and ISO 13485 seamlessly.
I can not see that any company can run two different QMS's. Help will be appreciated!

 

[twanmul]

There is no matrix that I am aware of. I know where this has been done, there tends to be an ISO13485 gap analysis against the specific QMS. One GMP compliant QMS is not necessarily the same as another and as such where one manufacturer feels and element of their GMP compliant QMS meets one part of the standard whereas another company may feel that they don't.
Having said that, the gaps between the standard and a GMP QMS that I think are most likely common are:
- Quality Policy & Quality Objectives
- Risk Management processes (adapting to be ISO14971 compliant with Risk/Benefit focus)
- Management review (this is more likely to need some tweaks to existing systems rather than a re-hash)
- Review Output (Analysis)
- Design & Development/Design Control
- Feedback
- Rework

In terms of the directives (or regulations), the biggest difference is assigning an intended purpose, classification, conformity assessment (including notified body approval, where necessary), performance and clinical evaluation, different reporting & vigilance requirements.

Hope that gives you a starter, without me knowing your QMS.

 

[AndretN]

Dear twanmul,
Thank you for your input, we have assisted 150 companies worldwide with ISO 13485, CE-Mark and FDA approvals.
We lately come across a number of instances where pharma companies wants to become involved in Medical Devices and needs to implement ISO 13485 on top of their existing GMP for their medicines. I am a firm believer that a QMS must add value and must be process orientated to manage the company. Often we are faced with resistance by the traditional Responsible Pharmacist who just simply do not want to adopt new thinking...
Any other inputs are valued!

 

[orleanna]

I have studied the subject more in depth since starting this thread in june. I have put a big accent on the risk management, I feel like the separate standard offers a wide perspective and the whole process of risk assessment is a bit different, plus it's one of the easy parts for me personally. I have a background in pharmaceuticals so as AndretN has mentioned, the GMP oriented pharmaceutical way of thinking, confused me a lot and made me and some colleagues who are also interested in the subject brain storm with quite a lot in the past few months. I feel like starting with the risk management is a good idea as when we tried putting the risks on paper, we as someone who's used to something completely different were able to see the bigger picture of the path one could take when adapting the ISO. I have minimal training and I did not deal with ISO 13485 in my work environment, but I feel like the most important point here is to have it work in a parallel manner without mixing them up. Maybe even having two separate quality assurance sub-departments for this and different operators trained for each type of product a company manufactures.