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9 CFR Ch. I (1–1–11 Edition) § 114.8

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9 CFR Ch. I (1–1–11 Edition) § 114.8 § 114.8 9 CFR Ch. I (1–1–11 Edition) (c) All biological products prepared ferred to as an approved outline, ap- at licensed establishments shall be pre- proval for filing constitutes no en- pared and handled with due sanitary dorsement by Animal and Plant Health precautions. Good sanitary measures Inspection Service of such biological shall be practiced at all times by all product or the methods and procedures personnel involved in such preparation used to prepare such biological prod- and handling of biological products. uct. (1) The clothing worn by persons (c) One copy of the Outline of Produc- while preparing biological products tion shall be retained by the Animal shall be clean. All persons, imme- and Plant Health Inspection Service diately before entering laboratory and one copy returned to the licensee rooms of a licensed establishment, shall change their outer clothing or ef- or permittee. fectively cover the same with gowns or (d) Each licensee shall review each other satisfactory clean garments. Outline of Production for accuracy and (2) Unsanitary practices such as, but sufficiency not less frequently than not limited to, eating, smoking, or ex- once a year. Revisions necessary to pectorating on the floors or otherwise bring an Outline of Production into creating a nuisance in any room, com- compliance with the regulations shall partment, or place in which biological be submitted to Animal and Plant products are prepared, handled, or Health Inspection Service. stored at licensed establishments are (e) When a list of licensed products to prohibited. be continued in production at a li- (Approved by the Office of Management and censed establishment is requested by Budget under control number 0579–0013) the Administrator in accordance with [39 FR 16869, May 10, 1974, as amended at 48 § 102.5(d) of this subchapter, the li- FR 57473, Dec. 30, 1983; 56 FR 66784, Dec. 26, censee shall supplement the list with 1991] information for each product as fol- lows: § 114.8 Outline of Production required. (1) The Outline of Production cur- An Outline of Production shall be on rently being used shall be identified as file with Animal and Plant Health In- to the date when last revised and filed spection Service for each licensed bio- with Animal and Plant Health Inspec- logical product or for each biological tion Service and the date of the last re- product authorized to be imported into view made by the licensee. the United States for Distribution and (2) The Outline of Production to be Sale. Preparation of a biological prod- kept in the active file shall be des- uct in a licensed establishment shall be ignated. If more than one has been filed in accordance with the Outline of Pro- for a product, only the Outline of Pro- duction for such product filed with duction currently being used shall be Animal and Plant Health Inspection included. Service as provided in this section, but subject to changes as may be required (f) The Administrator may, upon the under § 114.8(f). basis of information not available to (a) The Outline of Production shall him at the time the current Outline of be prepared as prescribed in § 114.9 and Production for a biological product was submitted to Animal and Plant Health filed, object to the methods or proce- Inspection Service for filing. When ob- dures being used in the preparation of jectionable features, if any, are cor- such biological product and notify the rected and no further exceptions are licensee to modify the filed Outline of taken by Animal and Plant Health In- Production to eliminate such objec- spection Service to an Outline of Pro- tions. If the licensee does not comply duction for a biological product, such with the notice, the Administrator Outline of Production shall be ap- may, after affording opportunity for a proved for filing. hearing to the licensee, suspend the (b) Each page shall be stamped as product license for the biological prod- filed on the date such action was taken uct involved; in which case, the li- in the bottom right hand corner. Al- censee shall not prepare such product though the filed outline may be re- until subsequent notice of withdrawal 804 VerDate Mar<15>2010 09:46 Mar 15, 2011 Jkt 223028 PO 00000 Frm 00814 Fmt 8010 Sfmt 8010 Y:\SGML\223028.XXX 223028 erowe on DSK5CLS3C1PROD with CFR Animal and Plant Health Inspection Service, USDA § 114.9 of the suspension is given to the li- on the Internet at (http:// censee. www.aphis.usda.gov/animallhealth/ vet biologics/vb forms.shtml). (Approved by the Office of Management and l l Budget under control number 0579–0013) (b) Special outline. An outline describ- ing the preparation of a component of [39 FR 16869, May 10, 1974, as amended at 48 a biological product or an operation FR 57473, Dec. 30, 1983; 56 FR 66784, Dec. 26, 1991; 75 FR 20773, Apr. 21, 2010] performed in the preparation of a bio- logical product may be required if such § 114.9 Outline of Production guide- special outline could be referred to in lines. Outlines of Production to eliminate Each Outline of Production shall be repetition. Each special outline shall prepared in accordance with the appli- be identified by number and shall not cable directions provided in this sec- be used until accepted and filed by Ani- tion. mal and Plant Health Inspection Serv- (a) General requirements. (1) All copies ice. of each Outline of Production or spe- (c) Outline of Production for anti- cial outline or revised pages of either serum, antitoxin, and normal serum shall be prepared on heavy paper shall be written according to the fol- (8.5″ x11″) of a type receptive to perma- lowing: nent stamp ink. OUTLINE GUIDE FOR PRODUCTION OF ANTI- (2) The name of the biological prod- SERUM AND ANTITOXIN AND NORMAL SERUM uct (or component), the establishment license number, and the date prepared License No. Name of Product Date shall appear on a front cover page and I. Serum animals. A. Species, conditions, each page of the Outline of Production age, and general health. B. Examination, preparation, care, quar- or special outline. The name of the li- antine, tests, and treatment of animals be- censee (or foreign manufacturer) shall fore injections are started. appear on the front cover page. C. Holding, handling, exercising, and moni- (3) The pages shall be numbered in toring the condition of animals after injec- the upper center. At least 11⁄2 inch mar- tions are started. gin shall be left at the top of the first II. Antigens. A. Composition and character page and a 2 inch margin at the bottom of the antigen. 1. Micro-organisms. of each page for the Animal and Plant 2. Source and date of accession of each Health Inspection Service stamp. micro-organism. (4) Amended pages shall be numbered 3. Strains. the same as those being superseded. 4. Proportions of each micro-organism and They shall bear the date prepared and strain. refer to the date on the pages being su- B. Identification methods used for each perseded. If one replacement page su- micro-organism and frequency with which these methods are applied. persedes more than one page, the new C. Virulence and purity of cultures or anti- page shall indicate same, but if several gen and the determination and maintenance replacement pages are added to super- thereof. Range of subcultures or passages to sede one page, the page number fol- be used in production. lowed by letters shall be used. D. Attenuation, if any, before use for pro- (5) The last page of both copies of ei- duction purposes. ther a new or a completely rewritten E. Character, size, and shape of containers Outline of Production and each page used for growing micro-organisms. F. Media used for stock, seed, and antigen revised separately shall be signed in cultures (composition and reaction of). May the lower left corner by the authorized refer to a special outline by number. representative of the licensee (or for- G. Preparation of the antigen or toxin and eign producer). Stamped or facsimile toxoid. Complete and full description of each signatures are not acceptable. step and its manner of accomplishment and (6) A summary of changes shall ap- number these steps in sequence. Include all pear on an attached page and refer to tests for each antigen, and the specifications each page, paragraph, or subparagraph for character, identity, virulence, concentra- tion, and standardization. being changed. III. Immunization of animals. A. Outline (7) Transmittal forms shall be used fully with special attention given to the fol- for the original and subsequent revi- lowing: sions. Transmittal forms are available 1. Character and dose of the antigen. 805 VerDate Mar<15>2010 09:46 Mar 15, 2011 Jkt 223028 PO 00000 Frm 00815 Fmt 8010 Sfmt 8010 Y:\SGML\223028.XXX 223028 erowe on DSK5CLS3C1PROD with CFR.
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