a person who is authorized to perform designated functions for which he or she is trained and qualified (AATB Standards 11th edition).

a set of criteria to ensure that recipients get equitable access to healthcare of appropriate quality for all, in which potential recipients get a ranking order on the basis of relevant medical urgency criteria (including waiting time).

cells or tissues removed from one person and applied to another (2004/23/EC).

processing is performed under clean room conditions. No terminal sterilisation that sterilises all product or package components is carried out (EATB 2003).

a documented review of procedures, records, personnel functions, equipment, materials, facilities and/or vendors in order to evaluate adherence to written SOPs, standards or government laws and regulations (CoE Guide 2004).

cells or tissues removed from and applied to the same person (2004/23/EC).

a defined quantity of tissue produced according to a single processing cycle during the same processing cycle which is intended to have uniform character and quality within specific limits, precluding mixing of cells and/or tissue from two or more donors (EATB 2003).

population of viable micro-organisms found on a given amount of material (EATB 2003).

the set of operations which establish, under specified conditions, the relationship between values indicated by a measuring instrument or measuring system, or values represented by a material measure, and the corresponding known values of a reference standard (EUDRALEX Volume 4 - Medicinal Products for Human and Veterinary Use: Good Manufacturing P [..]

individual human cells or a collection of human cells when not bound by any form of connective tissue (2004/23/EC).