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Is there an FDA requirement for a Supplier Audit Schedule

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B

Bunny

#12
#12
Yes, it is based upon risk; risk of the device and risk of the components. You can not rely on parts inspection to qualify your vendors.
 
M

MIREGMGR

#14
#14
We (my employer) normally do an on-site periodic audit only of those suppliers that provide us with sterilization services, and/or that do contract/component manufacture of products that have sterile barrier functionality and/or that they sterile barrier package.

We also do site visits by qualified specialist engineers, but not formal on-site audits, for suppliers of sterile barrier packaging materials.

Other suppliers are periodically re-qualified by review of quality records, reference to updated certifications, questionaire responses and the like.

We, like many other companies, were burned by the Pharmaceutical Innovations fiasco...in our case, to a very limited extent because we'd already cut them off due to uneasiness plus the difficulty of working with their owner, but still it was a sobering lesson. We had not done a full audit of them, including review of validations. Part of that was due to their being ISO 13485 certified, and our believing their certificate, and part of it was that what they supplied us was under their name, and we just kit-packed it. And, we had some "shortage of resources, have to prioritize" thinking. We also don't have an in-house deep knowledge of the oddball dry-heat-through-foil sterilization approach they were using, and had been using forever including through previous FDA reviews. Big mistake. We won't do that again.
 
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T

TWA - not the airline

Trusted Information Resource
#15
#15
What we do is to have a component control plan for each device. Based on the risk of a component failure for the safety and performance of the device we define what control is needed. Typically class III devices have more critical components than class I, but there are also some class III device components that have very low risk (sometimes lower than the more critical ones of a class I device). Depending on the risk class of the component we may e.g. need to use only suppliers with a quality systems in place, a signed quality agreement and we may have to audit them regularly. Component risk assessment also governs extend and frequency of the incoming inspection.
On the supplier side we have an initial supplier qualification based on a questionaire, general reputation and experience (this may also mean an initial audit) and the quality of the first shipment. Once this is done we regularly assess our supplier (mostly based on the quality they deliver) and based on the results we may need to adapt incoming inspections or the frequency of supplier audits (maybe even down to zero) or eventually change the supplier and qualify a new one.
Generally I think that most of the time it makes little sense to regularly audit suppliers that are 13485 certified; the beef is in the processes and if you are shown a validation you can only start nitpicking on formalities but never really assess whether they have the important aspects under control or not. For essential or critical components however it makes sense to do an initial audit and check whether the cert is just a piece of paper or if your supplier really has a system and knows quality. Once you are sure of that, you can leave the rest to the regular re-certification audits. My :2cents:
 
V

v9991

Trusted Information Resource
#16
#16
here's another pertinent reference...

Contract Manufacturing Arrangements for Drugs: Quality Agreements
this document provides wider clarity (especially the 4-case studies illustrate)on the binding/ownership of compliance on both owner and contract organization;
4Quality Agreements described in this guidance should also be used by Owners of combination products as they are subject to requirements under 21 CFR 211, 21 CFR 820, or both (see 21 CFR 4.3). In addition to facilitating compliance with requirements under 21 CFR 211, Quality Agreements with Contracted Facilities would also be appropriate for demonstrating compliance, in part, with 21 CFR 820.50 (Purchasing Controls) and with 21 CFR 820.80(b) (Receiving Acceptance Activities), for the combination product..
Click to expand...
 

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Ronen E

Ronen E

Problem Solver
Staff member
Moderator
#17
#17
v9991 said:
here's another pertinent reference...

Contract Manufacturing Arrangements for Drugs: Quality Agreements
this document provides wider clarity (especially the 4-case studies illustrate)on the binding/ownership of compliance on both owner and contract organization;
Click to expand...
Just to clarify, on p. 1 of the guidance it says:

This guidance does not cover the following types of products: Type A medicated articles and medicated feed, medical devices, dietary supplements, or human tissues intended for transplantation regulated under section 361 of the Public Health Service Act.
Click to expand...
(Emphasis added)
 
S

ssarangapani

#18
#18
Re: Supplier Audit Schedule

SuperGirl said:
I don't be believe you have to audit all your suppliers in the sense of "Hey, we're here to audit you". Do you inspect parts or what ever the suppiler supply as is arrives? If so, are you not doing a sort of "audit" of the suppiler that way?
Click to expand...
Does not seem to be enough for FDA. Recently they have been strict about supplier audits. Excuses like, we are too small to conduct audit of big companies do not seem to go well with the FDA auditor. However, you can put in place an audit assessment form, that relies on the incoming inspection and say that a particular supplier meets or exceeds your standards.
 
Ronen E

Ronen E

Problem Solver
Staff member
Moderator
#19
#19
Re: Supplier Audit Schedule

ssarangapani said:
Does not seem to be enough for FDA. Recently they have been strict about supplier audits. Excuses like, we are too small to conduct audit of big companies do not seem to go well with the FDA auditor. However, you can put in place an audit assessment form, that relies on the incoming inspection and say that a particular supplier meets or exceeds your standards.
Click to expand...
I can't really say how concerned FDA is with the consequences of this specific approach (provided that it really is their policy) for small manufacturers, but they ARE definitely concerned with the well-being of such manufacturers. FDASIA actually made them accountable to that, refer the attachment.
 

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M

MIREGMGR

#20
#20
Re: Supplier Audit Schedule

Ronen E said:
(...) small manufacturers, but they ARE definitely concerned with the well-being of such manufacturers.
Click to expand...
...right up to the point where the regulated small business offers their small size as an excuse for why they didn't conform to the small-business-accommodating device safety and effectiveness requirements...at which point, the basic requirement comes to the fore: being too small/understaffed/not having the money for the costs of following the rules is not an acceptable excuse.
 
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