Testing terminology.

CFR · 2024-01-01 · US · Title 9

Terms used when evaluating biological products shall mean: (a) (b) (c) (d) (e) (f) (g) (h) (i) (j) (k) (l) (1) (2) (3) (4) (m) (n) (o) (1) A completed serial of vaccine or bacterin prepared in accordance with a filed Outline of Production; (2) A purified preparation of a protective immunogen or antigen; or (3) A nonadjuvanted harvested culture of microorganisms. (p) (1) Master References; or (2) Serials of product that have been prepared and qualified, in a manner acceptable to Animal and Plant Health Inspection Service for use as reference preparations. (q) (2) Qualifying serials used to requalify or extend the dating period of a Master Reference shall be determined to be immunogenic in accordance with methods deemed appropriate by the Animal and Plant Health Inspection Service as provided in paragraph (a)(1) of this section, and, in addition, shall be within their permitted dating period and have been prepared in accordance with the production method described in the currently filed Outline of Production. (r) (s)

official document · source cfr-2024 · id 9:§ 101.5