ISPE Glossary of Pharmaceutical and Biotechnology Terminology

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Material

(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.

Material

(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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