Controlling the quality of raw materials.
Medical device manufacturers generally recognize the importance of selecting appropriate raw materials of high quality for the formulation and manufacture of their products. However, the documentation of raw material specifications and acceptance procedures is not always in complete compliance with quality system requirements. This article will discuss the activities and documentation needed to demonstrate conformity with United States and European requirements for controlling the quality of selected raw materials.
Donawa
M E
ME
Donawa and Associates Ltd., Rome, Italy. donawa@srd.it
D001672:Biocompatible Materials / Q000737:chemistry / Q000145:classification / Q000592:standards*; D004282:Documentation; D004867:Equipment Design / Q000592:standards; D004864:Equipment and Supplies / Q000592:standards*; D005060:Europe; D006801:Humans; D007221:Industry / Q000331:legislation & jurisprudence / Q000592:standards; D008422:Materials Testing / Q000592:standards; D011786:Quality Control; D014481:United States