Contract Manufacturer must adhere to 21 CFR 820 - Can FDA require us to do this?

J

jscholen

#31
Just to bury the nail, the Preamble states, " FDA notes that the legal authority exists to cover componant manufacturers under CGMP regulation should the need arise".


Good Luck.
 
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M

melissa66

#32
I agree with MIREGMGR. I had the same questions while I was working on a 510K....My company designs products for another company and we have the products manufactured at a total different company. Though, the company we design the product for basically puts their name on the product and is repsonsible for marketing and complaints...they are still subjected to PORTIONS of 21 CFR 820. My company is the one that files with the FDA and maintains a QS, however, since the other company contributes by handling labeling, complaints and servicing records, this company also need to be linked within our QS....even if we control it. I had discussed this with the FDA for the same concerns as you. So, as MIREGMGR said, "Certainly the FDA can inspect them if it determines doing so is necessary to verify that the operations they perform are being effectively controlled by you" and I would take a look at what processes the CM is responsible for and how that links to your QS.
 
K

KCole

#33
Hello, I am a new user here, hopefully I am not repeating a question that has been asked before (I did my search... :))...
I am looking to confirm whether FDA's 21 CFR 820 applies ONLY to medical device companies? How about pharmaceuticals and clinical trial companies? The way I read it, seems it only applies to medical device. Can someone confirm?
 
M

MIREGMGR

#34
I assume you're aware of 21CFR 211 (CGMP for pharma), and the other pharma-related 21CFR sections?

There's a directory at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm.

21CFR 820 sometimes can have some applicability to drugs that have device-like characteristics, i.e. administration methods or biological-effect mechanisms. Also, some elements of 21CFR (and FDA guidances as well) have applicability outside of their stated scope, i.e. the current broadly applicable standard for FDA acceptability of symbolic communications on packaging is the IVD labeling guidance...title notwithstanding.
 
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rmf180

Involved In Discussions
#35
Re: Can FDA require us to do this?

With all due respect, if I were you I'd find a better horse to ride. This one's dead.
I agree, and would add the additional thought. One who continues to ride a dead horse, may find "himself" being fitted for a saddle of "his" own. :nono:
 
J

JayJay

#36
Re: Can FDA require us to do this?

......You, however, are subject to penalization based on their compliance to the regs...which you are legally required to control via your contractural relationship with them.
......


With all due respect, if I were you I'd find a better horse to ride. This one's dead.
Thanks for all the input everyone - for the last months I've been beefing up our vendor/materials/purchasing control procedures to require stringent controls for our manufacturer, as well as drafting a new contractual agreement to more specifically define our requirements for them. I've basically locked them into all of the requirements for production/process controls, and a few other miscellaneous portions of the regulation.

I don't expect to have this problem EVER again.

Again, thanks for everyone's input. :thanx:

I just hope our manufacturer doesn't run screaming in the opposite direction when we've informed them of the more stringent requirements.

Gotta love the FDA!
 
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