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Animal and Plant Health Inspection Service, USDA § 114.7

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Animal and Plant Health Inspection Service, USDA § 114.7 Animal and Plant Health Inspection Service, USDA § 114.7 (State) in storage at licensed establishments: [39 FR 16869, May 10, 1974, as amended at 60 Provided, That, if such ingredients, FR 48021, Sept. 21, 1995] components, or biological products are not so identified, they shall be disposed § 114.3 Separation of establishments. of as provided in § 114.15. (a) Each licensed establishment shall be separate and distinct from any other § 114.5 Micro-organisms used as seed. establishment in which a biological Micro-organisms used in the prepara- product is prepared. tion of biological products at licensed (b) No biological products authorized establishments shall be free from the to be prepared in a licensed establish- causative agents of other diseases or ment shall be prepared in whole or in conditions. A complete record of such part by another licensed establishment micro-organisms shall be kept cur- except as provided in paragraphs (c) rently correct and a list submitted to and (d) of this section. Animal and Plant Health Inspection (c) When a partially prepared biologi- Service upon request of the Adminis- cal product cannot be completed at a trator. licensed establishment due to failure of essential equipment, the Administrator (Approved by the Office of Management and may authorize the use of similar equip- Budget under control number 0579–0059) ment at another licensed establish- [39 FR 16869, May 10, 1974, as amended at 48 ment: Provided, That, such authoriza- FR 57473, Dec. 30, 1983; 56 FR 66784, Dec. 26, tion shall be limited to the duration of 1991] the emergency and to the phase of pro- duction affected by the equipment fail- § 114.6 Mixing biological products. ure. Each biological product, when in liq- (d) Partially prepared products or se- uid form, shall be mixed thoroughly in rials of completed products for further a single container. During bottling op- manufacture may be moved from one erations, the product shall be con- licensed establishment to another li- stantly mixed sufficient to maintain censed establishment, imported under physical uniformity of the entire fill. A the provisions of § 104.5, or moved from a licensed establishment for purpose of serial number, with any other mark- being exported under conditions pre- ings that may be necessary for ready scribed in an Outline of Production identification of the serial, shall be ap- filed with Animal and Plant Health In- plied to identify it with the records of spection Service. Licensed products or preparation and labeling. products imported for distribution and sale may be prepared and recommended § 114.7 Personnel at licensed establish- ments. for final use, for further manufacturing purposes, or both. All serials shall be (a) Each licensee shall designate a subject to the requirements for testing person(s) to make all official contacts and release specified in § 113.5 or § 113.10 with Animal and Plant Health Inspec- and to the requirements for identifica- tion Service on matters pertaining to tion specified in § 114.4. the preparation of biological products under the Virus-Serum-Toxin Act. The [39 FR 16869, May 10, 1974, as amended at 40 FR 46093, Oct. 6, 1975; 49 FR 45846, Nov. 21, licensee shall file three copies of bio- 1984; 56 FR 66784, Dec. 26, 1991] graphical summary with Animal and Plant Health Inspection Service for § 114.4 Identification of biological such designated person and for each products. person responsible for any phase of Suitable tags or labels of a distinct preparation of a biological product. design shall be used for identifying all (b) All personnel employed in the ingredients used in the preparation of preparation of biological products at a biological products, all component licensed establishment shall be com- parts to be combined to form a biologi- petent in good laboratory techniques cal product, all biological products through education or training, or both, while in the course of preparation and so as to consistently prepare high qual- all completed biological products held ity products. 803 VerDate Mar<15>2010 09:46 Mar 15, 2011 Jkt 223028 PO 00000 Frm 00813 Fmt 8010 Sfmt 8010 Y:\SGML\223028.XXX 223028 erowe on DSK5CLS3C1PROD with CFR § 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.
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