Components
"Component" is defined in 820.3(c) of the Quality System (QS) regulation as any material, substance, piece, part, software, firmware, labeling, or assembly, which is intended to be included in the finished, packaged, and labeled device. For example, fasteners, blood tubing assemblies and labels are components. This definition excludes "manufacturing materials," which by definition, are not intended to be included as part of the finished, packaged, and labeled device.
According to 820.3(p), "manufacturing material" is any material or substance used in or used to facilitate the manufacturing process, a concomitant constituent, or a byproduct constituent produced during the manufacturing process, which is present in or on the finished device as a residue or impurity not by design or intent of the manufacturer. Examples of manufacturing materials include: cleaning agents, mold-release agents, lubricating oil, or other substance used to facilitate a manufacturing process which is not intended by the manufacturer to be included in the finished device.
Manufacturers of components sold only for further manufacturing of a medical device are not required to comply with the GMP requirements for finished devices. Many components of devices, such as transistors, containers, hardware, etc., are readily available in the marketplace and are not manufactured exclusively for use in devices. Many of these manufacturers supply only a small fraction of their production to finished device manufacturers. However, section 820.1 of the Quality System regulation encourages component manufacturers to use applicable GMP elements as guidance.
If a component is manufactured in the same or proximal facility, and produced for use in finished medical devices, then the component is considered part of the production of the finished devices and is subject to the applicable requirements of the GMP requirements. If the component is manufactured in a separate plant owned by the finished device manufacturer, then the manufacturer has flexibility in handling the quality assurance activities related to the control of components. One satisfactory approach is to have the plant that builds the components operate in full GMP compliance. Under this arrangement, the plant which does the final device assembly would still be responsible for ascertaining that the quality and integrity of incoming components have not been damaged during shipment. Alternately, the component manufacturing plant may not fully comply with Quality System regulation. Then the plant that does final assembly should handle the acceptance of these components with the same degree of control as if the components were purchased from an outside supplier.
For components such as labels, package inserts, packaging, etc., there is additional information in chapter 11, Labeling; and chapter 13, Packaging.