I work for a pharmaceutical company that recently purchased a medical device product. I have been assigned to create a Quality Manual that complies with ISO 13485 and 21 CFR 820. However, management doesn't want this to impact the operations for thier pharmaceutical products. In other words, they want me to create a Quality Manual that only applies to this medical device product, not to the rest of their quality system. - Does anyone have any experience with this type of situation? How do auditors respond to the use of dual quality systems?

I have seen many organizations where they have different divisions within the main organization handling Pharmaceuticals and Medical Devices seperately. Thus they segregate these businesses and have the individual systems for those segments.

This may be somewhat similar to the FDA setup where they have CDER, CDRH etc. :)

You say that your company has bought a medical device. Will you be producing it at a location that is new to the company, or will it be produced at an existing site where you also produce pharmaceutical products?

We do both device and pharmaceutical manufacturing in our small NJ operation.
Keep one system and create an "applicable chart" that outlines what procedures apply to device and what pertains to the pharma end. Product development, complaint and validation are areas that device has differing requirements.
Keep it simple and as much the same to make following easier.
Keith

We also do both. We can combine most parts of the requirements of 13485/CFR820 and CFR210/211 into one manual. The only major variance is that we have two product realization sections in the manual, one for MD and one for Pharma, everything else seems to be equally applicable. Been working OK for FDA and ISO/NB audits so far,:cfingers:

Jimmy

Thanks for the feedback! I guess it's not an unusual situation. The manufacturing of our device occurs in several parts. They want to bring some of the manufacturing on site, while other parts will continue to be contracted out to the current approved facilities. - In general, it hasn't been very smooth going.

If your company manufactures both pharmaceuticals and devices (regulated as such), then you would need to comply with both 21 CFR 211 and 21 CFR 820. However, if you manufacture combination drug/device products, then the product that has the primary mode of action would be the primary quality system, with certain aspects of the other added in. For example, if you have a combination drug/device that's regulated as a drug, you follow all of 21 CFR 211, and you add the following elements from 21 CFR 820: Design Control, Purchasing Controls, and CAPA. You wouldn't need to follow both regulations in full.

Hope that helps.

That's a good point. The product actually is a combination drug/device product. The primary classification seems to vary from country to country, but the markets that we are currently approved in classify it as a device. - In either case, we don't have ISO certification yet, so we'd still have a lot of work ahead of us. Thanks!

One of the other things you are going to face in your company, depending on the background of your employees is the sheer difference in approach in attitude and understanding that can exist between people from the "two different worlds".

I see it all the time, but as has been described above it is neither that uncommon, nor that hard to manage if you do your homework.