cGMP Regulations for Finished Pharmaceuticals and Medical Devices

Process validation is required, in both general and specific terms, by the Current Good Manufacturing Practice Regulations for Finished Pharmaceuticals, 21 CFR Parts 210 and 211. Examples of such requirements are listed below for informational purposes, and are not all-inclusive.

A requirement for process validation is set forth in general terms in Section 211.100 -- Written procedures; deviations -- which states, in part:
"There shall be written procedures for production and process control designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess."

Several sections of the CGMP regulations state validation requirements in more specific terms. Excerpts from some of these sections are:
Section 211.110, Sampling and testing of in-process materials and drug products.
(a) "....control procedures shall be established to monitor the output and VALIDATE the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product." (emphasis added)
Section 211.113, Control of Microbiological Contamination.
(b) "Appropriate written procedures, designed to prevent microbiological contamination of drug products purporting to be sterile, shall be established and followed. Such procedures shall include VALIDATION of any sterilization process." (emphasis added)

cGMP 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 applied 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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