Application of ISO 9002 and FDA's good manufacturing practices to general chemical manufacturing.
Two manufacturing standards are discussed and compared, namely, the U.S. Food and Drug Administration's Good Manufacturing Practices and the International Standards Organization 9000 (ISO 9000) series. Conclusions are drawn relative to quality improvement strategies.
Kauffman
J M
JM
Rohm and Haas Company, Philadelphia, Pennsylvania 19105.
Weiler
E D
ED
D004340:Drug Contamination / Q000517:prevention & control; D004345:Drug Industry / Q000592:standards*; D017408:Guidelines as Topic; D006801:Humans; D007390:International Agencies / Q000458:organization & administration; D009937:Organizational Objectives; D017060:Patient Satisfaction; D012015:Reference Standards; D017749:Total Quality Management / Q000458:organization & administration*; D014481:United States; D014486:United States Food and Drug Administration / Q000458:organization & administration