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(ISO/DIS 10993-1) Any synthetic or natural polymer, metal, alloy, ceramic, or other nonviable substance, including tissue rendered nonviable, used as a medical device, or any part thereof.
(ICH Q7) A general term used to denote raw materials (starting materials, reagents, solvents), process aids, intermediates, APIs and packaging and labeling materials.
Publication Source: ISPE Baseline® Guide, Vol. 6: Biopharmaceutical Manufacturing Facilities
Publication Date: 2004
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