You ask if 820.50 applies to all products, or just some. The answer starts with the of QSR, which says, “The requirements in this part govern the methods used in, and the facilities and controls used for, the design, manufacture, packaging, labeling, storage, installation, and servicing of all finished devices intended for human use.” Note that “finished device” is a technical term that may have a different meaning than colloquial language.
To properly implement this part you need to ask if the supplier’s product or service has an impact within the scope. The supplier that provides paper for an office copier probably does not. The supplier that prints instructions for use probably does.
If a cleaning service covers only office areas, probably not. However, if they enter a clean room then they probably should be covered.
Research is more difficult. If the researcher provides wonderful “pie in the sky” ideas for a new product, then probably not. If the researcher provides technical knowledge to implement a design, such as potential sterilization methods, then they should be covered.
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Dan O'Leary
Ombu Enterprises, LLC
Swanzey NH
United States
Original Message:
Sent: 12-15-2015 16:52
From: Joy Pelfrey
Subject: Purchasing Controls
Hello fellow RAPS members,
I would like to get your opinion on the interpretation of 21 CFR 820.50 (Purchasing Controls). The regulation states that the controls apply to "all purchased or otherwise received product and services..."
Does this really mean ALL products purchased by a manufacturer, regardless of the product's affect on the quality of the medical device? For example, should our office supply vendor or vendors associated with research be evaluated and added to our Approved supplier list?
Thanks in advance for your input.
-Joy
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Joy Pelfrey
Director of RA/QA
Norman OK
United States
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