Requirements to Manufacture a Pharmaceutical vs. Medical Device

[Dudes]

We are an ISO 13485 certified manufacturer of class III devices. We are thinking of developing a combination product where the main action would come from the pharmaceutical part. It would therefore probably have to be registered as a drug by the FDA.

What are the differences in the basic requirements for drug manufacturer vs. device manufacturer? For example: do we have hire a pharmacist? Does the QMS need to be changed? Is there any more stringent health requirement for the workers?

I guess it is a whole different ballpark, but I have no idea and can't seem to find the right information. I'd like to be able to give my management an idea of the work and changes involved...

Thanks for your help!

[Marc]

Can anyone here help with this one? It's out of my area of expertise. My Thanks in advance!

[arios]

My experience with drug-device combinations is limited. Anyways, I would like to share my two cents

This is the link with the FDA reg. for GMP's on pharma:

http://www.21cfrpart11.com/files/lib...p_annotate.pdf

Take a look and you will find several prescriptive requirements. I hope other members of the Cove can help you out with additional support information.

[Dudes]

Thanks for the link Amigo!

Lets see if someone else has more info...

[mehtagaurav_2004]

Hi everyone,

I am new to this Forum and would like appreciate the help you guys are doing...

I need to ask two things...
1. We are a Cosmetic Company and hence our laboratory is of Cosmetic Standard.

2. We are moving forward to make Medical Devices Class 1 and 2a. would we need any extra setup in the Laboratory ...do we need to upgrade the laboratory ....are there any set standards to design the MD such as GSP,GLP,GMP...do any of these standards have to followed while designing a medical device.

Any help would be highly appreciated!!!!

Thanks
G

[Ajit Basrur]

In Reply to Parent Post by mehtagaurav_2004

Hi everyone,

I am new to this Forum and would like appreciate the help you guys are doing...

I need to ask two things...
1. We are a Cosmetic Company and hence our laboratory is of Cosmetic Standard.

2. We are moving forward to make Medical Devices Class 1 and 2a. would we need any extra setup in the Laboratory ...do we need to upgrade the laboratory ....are there any set standards to design the MD such as GSP,GLP,GMP...do any of these standards have to followed while designing a medical device.

Any help would be highly appreciated!!!!

Thanks
G

First of all, get a copy of ISO 13485

[mehtagaurav_2004]

Dear Ajit,

Thanks for the reply.

I have gone htrough the ISO 13485 and couldnt find any specific information about what Laboratory Standards should we follow.

If you can direct me towards the right section of ISO ..i would really appreciate your help.

Regards,
G

[SHall]

Pharmaceutical requirements are very different than medical device. In particular, the requirements for cleanliness, release testing, stability testing, supplier quality assurance, and process validation are more stringent.

When I've worked with devices where there was a drug component, the pharma side was always outsourced to a contract manufacturer. There are wonderful economies of scale when using the services of a contract manufacturer. As noted by our Amigo, Arios, there are some very prescriptive requirements in 21 CFR Parts 210 and 211.

Is management prepared to have different procedures for the pharmaceutical components, or to have the medical device side burdened with pharmaceutical-grade processes?

Will the scale of this operation be sufficiently large to justify hiring appropriately qualified personnel for facilities, regulatory, quality assurance, etc?

Wouldn't they be better off sending you to meet some contract manufacturers in Puerto Rico, Ireland, or some other lovely place?