Medical Electronics Symposium Conference Proceedings


REGULATORY EXPECTATIONS FOR PROCESS VALIDATION

Author: Jim Schultz
Company: Benchmark Electronics
Date Published: 4/25/2005   Conference: Medical Electronics Symposium


Abstract: Medical device design and manufacturing requires a higher level of process control than most other products. The current Good Manufacturing Practice (GMP) requirements set forth in the Quality System Regulation (QSR) under section CFR21 Part 820 of the Food, Drug and Cosmetic (FD&C) Act requires that domestic or foreign manufacturers have a quality system for the design, manufacture, packaging, labeling, storage, installation, and servicing of finished medical devices intended for commercial distribution in the United States. The regulation requires that devices be designed and produced under a quality system that meets all specifications and that quality data be analyzed to identify and correct quality problems.

As a result, the QSR helps assure that medical devices are safe and effective for their intended use. The Food and Drug Administration (FDA) monitors device problem data and inspects the operations and records of device developers and manufacturers to determine compliance with the GMP requirements in the QSR. The FDA will commonly inspect the process validation report generated by the device manufacturer during the product launch. There are strict guidelines for how the process validation is generated.

The QSR outlined by the FDA defines process validation as establishing, by objective evidence, that a process consistently produces a product meeting its predetermined specifications. The requirement for process validation appears in section CFR21 Part 820.75 of the QSR. The goal of the quality system should be to consistently produce products that are fit for their intended use. Process validation is the key element in assuring that these goals are met.

The validation and submittal process for a new electronic device is extensive and consists of many steps. The scope of this topic is so vast that this paper will only focus on the equipment and process validation done by the Electronic Manufacturing Service (EMS) provider for its Original Equipment Manufacturer (OEM) customer. The validation process is commonly referred to as the IQ/OQ/PQ process or Installation Qualification, Operation Qualification, and Process Qualification process. The IQ/OQ/PQ process uses a structured approach to validate the installation and operation of production equipment, and the validation of the specific production processes used during the production of the products.

Keywords: medical, validation, IQ/OQ/PQ, FDA, QSR.



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