Outline of Production guidelines.

CFR · 2024-01-01 · US · Title 9

Each Outline of Production shall be prepared in accordance with the applicable directions provided in this section. (a) (2) The name of the biological product (or component), the establishment license number, and the date prepared shall appear on a front cover page and each page of the Outline of Production or special outline. The name of the licensee (or foreign manufacturer) shall appear on the front cover page. (3) The pages shall be numbered in the upper center. At least 1 (4) Amended pages shall be numbered the same as those being superseded. (5) The last page of both copies of either a new or a completely rewritten Outline of Production and each page revised separately shall be signed in the lower left corner by the authorized representative of the licensee (or foreign producer). Stamped or facsimile signatures are not acceptable. (6) A summary of changes shall appear on an attached page and refer to each page, paragraph, or subparagraph being changed. (7) Transmittal forms shall be used for the original and subsequent revisions. Transmittal forms are available on the Internet at ( (b) (c) Outline of Production for anti-serum, antitoxin, and normal serum shall be written according to the following: (d) Outline of Production for (e) Outlines of Production for allergenic extracts shall be written according to the following: (f) Outlines of Production for diagnostic test kits based on antigen-antibody reactions, and other diagnostics whose production methods are amenable t

official document · source cfr-2024 · id 9:§ 114.9