ELM-305-01

Purchasing Controls for Medical Device Companies (21 CFR Part 820.50) [Video]

The first part of the purchasing control regulations appears fairly innocuous.

There must be a receiving process which ensures product conforms to specified requirements.

At initial review this is straightforward and there must be an SOP defining the receiving process.

However, as we analyze that simple statement further, there is a lot more behind it.

The FDA’s Definition

First of all, product is defined by the FDA as “components, manufacturing materials, in-process devices, finished devices and returned devices.”

Components is further defined by the FDA as “any raw material, substance, piece, part, software, firmware, labeling, or assembly which is intended to be included as part of the finished, packaged and labelled device.”

So, what this seemingly simple regulation is saying is that any material that is going to be used as a component or part of the finished product must be received against specified requirements.

Part Numbers

One question that often arises is, “do we need a part number for every part that goes into our product?” The part number is used as the identifier which then defines the specified requirements for that specific part.

It is not really possible to have specific requirements without a specific part number.

Another common mistake is to extend this requirement to all materials, which may be received where the requirement is specific to product (inclusive of any components).

Evaluated

That’s not to say it cannot be applied to all materials, but this typically is overly burdensome to the organization without any real added benefit.

Materials that are not “product” by the FDA’s definition must be evaluated for the need to control them at the same level as product.

Author

Don Rackham

Associate Director QA Asterias Biosciences