Medical good manufacturing practices

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. 

Good Manufacturing Practice for Medical Products, European Community, 1992. 

Guideline of the Commission for Principles of Good Manufacturing Practice for Medical Products, Directive 91/356/EEC, 1991. 

Current good manufacturing practice for medical gases http //www.fda.gov/ cder/guidance/3823dft.pdf... 

Recommendation on Validation Master Plan, Installation and Operational Qualification, Non-Sterile Process Validation and Cleaning Validation. This document is the basis for Annex 15 to the EC Guide on Good Manufacturing Practices for Medical Products. Figure 4 displays the most commonly used topics to be described in a VMP. 

EC. Guide on Good Manufacturing Practices for Medical Products. EU (2001). 

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. 

European Commission. The Rules Governing the Medical Products in the European Union, Volume 4, Good Manufacturing Practices. Brussels Directorate General BI—Industry, Pharmaceuticals and Cosmetics (1998). 

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. 

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

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