FDA CAPA Requirement for Contract Med. Dev. Manufacturers

L

LNeJame

#1
Hi All,

I heard fairly recently that the FDA had put out a new requirement that all Contract Medical Device manufacturers as well as all Contract Sterilizers, must have some form of CAPA system in place. Can anyone shed some light on this subject? Is there a new regulation laid out in the CFR or any other place that someone could point me to?

Thank you in advance for your help,

Larry
 
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Doug Tropf

Quite Involved in Discussions
#2
I haven't seen anything new from FDA on CAPA, it is still a hot button enforcement item. Contract sterilizers must have a CAPA system in place.
 
M

MIREGMGR

#3
If you perform a regulated process as a Contract Manufacturer, as Doug says, you must control that process, have a CAPA system and participate in post-market surveillance. Both you and your customers share full responsibility for your performance.

Everything else you do in regard to the production of medical devices, of course, is fundamentally the regulatory responsibility of your customers. They must have supervisory controls in place.

The most obvious examples of regulated processes are product sterilization and product sterile-barrier packaging.

There have been at least a couple of relatively recent contract manufacturer field inspections (as made visible by 483s...I don't know of any otherwise-comprehensive data on how common this actually is) where the FDA has given the impression that, because the firm doing the contract manufacturing is also a registered device maker in their own regard and has a quality system, the regulatory expectation-level for the contract manufacturer would be elevated. I'm not aware of any public acknowledgement that such a stance is now policy, though.
 

Doug Tropf

Quite Involved in Discussions
#4
You might have a look at the Sterilization Process Controls section of the FDA's "Quality System Inspection Technique", CAPA is mentioned several times.
 
G

gar4guv

#5
hi larry,

i don't believe its anything new, but i am fairly certain that contract (oem) manufactures need to have a full quality system in place with the exception of design controls.

MIREGMGR is right about the regulatory issues being the responsibility of your customer, since it is their name on the product

here are some sections i got from the FDA website


Sec. 820.3 Definitions

(o)Manufacturer means any person who designs, manufactures, fabricates, assembles, or processes a finished device. Manufacturer includes but is not limited to those who perform the functions of contract sterilization, installation, relabeling, remanufacturing, repacking, or specification development, and initial distributors of foreign entities performing these functions.

Sec. 820.5 Quality system. Each manufacturer shall establish and maintain a quality system that is appropriate for the specific medical device(s) designed or manufactured, and that meets the requirements of this part.
 
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