GMP Regulation for Medical Devices

Process validation is required by the medical device GMP Regulations, 21 CFR Part 820. Section 820.5 requires every finished device manufacturer to:

“…prepare and implement a quality assurance program that is appropriate to the specific device manufactured…”

Section 820.3(n) defines quality assurance as:

“…all activities necessary to verify confidence in the quality of the process used to manufacture a finished device.”

When applicable to a specific process, process validation is an essential element in establishing confidence that a process will consistently produce a product meeting the designed quality characteristics.

A generally stated requirement for process validation is contained in section 820.100:

“Written manufacturing specifications and processing procedures shall be established, implemented, and controlled to assure that the device conforms to its original design or any approved changes in that design.”

Validation is an essential element in the establishment and implementation of a process procedure, as well as in determining what process controls are required in order to assure conformance to specifications.

Section 820.100(a) (1) states:

“…control measures shall be established to assure that the design basis for the device, components and packaging is correctly translated into approved specifications.”

Validation is an essential control for assuring that the specifications for the device and manufacturing process are adequate to produce a device that will conform to the approved design characteristics

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