Medical devices Good manufacturing practices

FDA ( 99 ), Medical Device Good Manufacturing Practices Manual, 5th Edition, ISBN 0-16-035844-2, U.S. Government Printing Office, Washington, D.C. 

Quality system regulation The past good manufacturing practice (GMP) and process validation (PV) was renamed to quality system regulation (QSR). It is important for the medical device industry (that uses an extensive amount of plastics) and also in other product industries where they want to follow strict processing procedures. It sets up an important procedure for many plastic fabricators to consider that targets to ensure meeting zero defects. 

Class 1 medical devices, which include some simple IVDs, are usually exempt from the premarket section 510(k) application process, and their manufacturers are only required to register and list, follow good manufacturing practices, and report device failures. As experience develops with a given medical device it can be reclassified downward from class 3 to class 2 and eventually to class 1. 

Examples of the U.S. regulations applicable to computer system application in a GMP environment are shown in Table 1. The FDA also publishes compliance policy guides [7] related to pharmaceutical drag products and views the guidance provided on related products (e.g., medical devices [8]) to be current good manufacturing practice that should be considered for comparative GMP applications. 

U.S. Food and Drug Administration. Medical devices current good manufacturing practice (CGMP). Fed Reg Part 820, Quality System Regulation. Rockville, MD (1996). 

Department of Health and Human Services, Food and Administration, 21 CFRParts 808, 812, and 820 Medical Devices Current Good Manufacturing Practice (CGMP) Final Rule, Federal Register, 61 (195), 52602-52662, October 7,1996, comment paragraph 136. 

U.S. Code of Federal Regulations Title 21 Part 820, Good Manufacturing Practice for Medical Devices. 

Process validation is a requirement of current Good Manufacturing Practices (GMPs) for finished pharmaceuticals (21 CFR 211) and of the GMP regulations for medical devices (21 CFR 820) and therefore applies to the manufacture of both drug products and medical devices. 

Drug manufacturers must confirm that GMP (Article 13 of the PAL) emd Good Manufacturing Practice for Import (GMPI) have been implemented in April 1994 to secure the quality of imported drugs and medical devices. 

CGMP. (Current Good Manufacturing Practices). Refers to the body of regulations that describe the methods, equipment, facilities, and controls required for producing human and veterinary products, medical devices, and processed food. 

Process validation is a requirement of the FDA Current Good Manufacturing Practices Regulations for Finished Pharmaceuticals, 21 CFR Parts 210 and 211, and of the Good Manufacturing Practice Regulations for Medical Devices, 21 CFR Part 820, and therefore, is applicable to the manufacture of pharmaceuticals and medical devices intended for the United States. 

Department of Health and Social Security (1981). Guide to Good Manufacturing Practice for Medical Devices and Surgical Products. 1981. London Her Majesty s Stationery Office. 

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