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45 Part 606—Current Good Man- Ufacturing Practice Food and Drug Administration, HHS Pt. 606 a presentation. The presiding officer ucts approved under § 601.91, the re- may, as a matter of discretion, permit strictions would no longer apply when questions to be submitted to the pre- FDA determines that safe use of the bi- siding officer for response by a person ological product can be ensured making a presentation. through appropriate labeling. FDA also (f) Judicial review. The Commissioner retains the discretion to remove spe- of Food and Drugs’ decision constitutes cific postapproval requirements upon final agency action from which the ap- review of a petition submitted by the plicant may petition for judicial re- sponsor in accordance with § 10.30 of view. Before requesting an order from a this chapter. court for a stay of action pending re- view, an applicant must first submit a PART 606—CURRENT GOOD MAN- petition for a stay of action under § 10.35 of this chapter. UFACTURING PRACTICE FOR BLOOD AND BLOOD COMPO- [67 FR 37996, May 31, 2002, as amended at 70 NENTS FR 14984, Mar. 24, 2005] § 601.93 Postmarketing safety report- Subpart A—General Provisions ing. Sec. Biological products approved under 606.3 Definitions. this subpart are subject to the post- marketing recordkeeping and safety Subpart B—Organization and Personnel reporting applicable to all approved bi- ological products. 606.20 Personnel. § 601.94 Promotional materials. Subpart C—Plant and Facilities For biological products being consid- 606.40 Facilities. ered for approval under this subpart, unless otherwise informed by the agen- Subpart D—Equipment cy, applicants must submit to the agency for consideration during the 606.60 Equipment. preapproval review period copies of all 606.65 Supplies and reagents. promotional materials, including pro- motional labeling as well as advertise- Subpart E [Reserved] ments, intended for dissemination or Subpart F—Production and Process publication within 120 days following Controls marketing approval. After 120 days fol- lowing marketing approval, unless oth- 606.100 Standard operating procedures. erwise informed by the agency, the ap- 606.110 Plateletpheresis, leukapheresis, and plicant must submit promotional ma- plasmapheresis. terials at least 30 days prior to the in- tended time of initial dissemination of Subpart G—Additional Labeling Standards the labeling or initial publication of for Blood and Blood Components the advertisement. 606.120 Labeling, general requirements. § 601.95 Termination of requirements. 606.121 Container label. 606.122 Circular of information. If FDA determines after approval under this subpart that the require- Subpart H—Laboratory Controls ments established in §§ 601.91(b)(2), 601.92, and 601.93 are no longer nec- 606.140 Laboratory controls. essary for the safe and effective use of 606.145 Control of bacterial contamination a biological product, FDA will so no- of platelets. tify the applicant. Ordinarily, for bio- 606.151 Compatibility testing. logical products approved under § 601.91, these requirements will no Subpart I—Records and Reports longer apply when FDA determines 606.160 Records. that the postmarketing study verifies 606.165 Distribution and receipt; procedures and describes the biological product’s and records. clinical benefit. For biological prod- 606.170 Adverse reaction file. 45 VerDate Sep<11>2014 11:11 May 16, 2017 Jkt 241076 PO 00000 Frm 00055 Fmt 8010 Sfmt 8010 Q:\21\21V7.TXT 31 lpowell on DSK54DXVN1OFR with $$_JOB § 606.3 21 CFR Ch. I (4–1–17 Edition) 606.171 Reporting of product deviations by (j) Compatibility testing means the licensed manufacturers, unlicensed reg- procedures performed to establish the istered blood establishments, and trans- matching of a donor’s blood or blood fusion services. components with that of a potential re- AUTHORITY: 21 U.S.C. 321, 331, 351, 352, 355, cipient. 360, 360j, 371, 374; 42 U.S.C. 216, 262, 263a, 264. (k) Distributed means: SOURCE: 40 FR 53532, Nov. 18, 1975, unless (1) The blood or blood components otherwise noted. have left the control of the licensed manufacturer, unlicensed registered Subpart A—General Provisions blood establishment, or transfusion service; or § 606.3 Definitions. (2) The licensed manufacturer has As used in this part: provided Source Plasma or any other (a) Blood means a product that is a blood component for use in the manu- fluid containing dissolved and sus- facture of a licensed biological product. pended elements which was collected (l) Control means having responsi- from the vascular system of a human. bility for maintaining the continued (b) Unit means the volume of blood or safety, purity, and potency of the prod- one of its components in a suitable vol- uct and for compliance with applicable ume of anticoagulant obtained from a product and establishment standards, single collection of blood from one and for compliance with current good donor. manufacturing practices. (c) Blood component means a product [40 FR 53532, Nov. 18, 1975, as amended at 64 containing a part of human blood sepa- FR 45370, Aug. 19, 1999; 65 FR 66635, Nov. 7, rated by physical or mechanical means. 2000; 66 FR 1835, Jan. 10, 2001; 66 FR 40889, (d) Plasma for further manufacturing Aug. 6, 2001; 72 FR 45886, Aug. 16, 2007; 80 FR means that liquid portion of blood sep- 29894, May 22, 2015] arated and used as material to prepare another product. Subpart B—Organization and (e) Plasmapheresis means the proce- Personnel dure in which blood is removed from the donor, the plasma is separated § 606.20 Personnel. from the formed elements and at least (a) [Reserved] the red blood cells are returned to the (b) The personnel responsible for the donor. collection, processing, compatibility (f) Plateletpheresis means the proce- testing, storage or distribution of blood dure in which blood is removed from a or blood components shall be adequate donor, a platelet concentrate is sepa- in number, educational background, rated, and the remaining formed ele- training and experience, including pro- ments are returned to the donor along fessional training as necessary, or com- with a portion of the residual plasma. bination thereof, to assure competent (g) Leukapheresis means the proce- performance of their assigned func- dure in which blood is removed from tions, and to ensure that the final the donor, a leukocyte concentrate is product has the safety, purity, po- separated, and the remaining formed tency, identity and effectiveness it pur- elements and residual plasma are re- ports or is represented to possess. All turned to the donor. personnel shall have capabilities com- (h) Facilities means any area used for mensurate with their assigned func- the collection, processing, compat- tions, a thorough understanding of the ibility testing, storage or distribution procedures or control operations they of blood and blood components. perform, the necessary training or ex- (i) Processing means any procedure perience, and adequate information employed after collection, and before concerning the application of pertinent or after compatibility testing of blood, provisions of this part to their respec- and includes the identification of a tive functions. unit of donor blood, the preparation of (c) Persons whose presence can ad- components from such unit of donor versely affect the safety and purity of blood, serological testing, labeling and the products shall be excluded from associated recordkeeping. areas where the collection, processing, 46 VerDate Sep<11>2014 11:11 May 16, 2017 Jkt 241076 PO 00000 Frm 00056 Fmt 8010 Sfmt 8010 Q:\21\21V7.TXT 31 lpowell on DSK54DXVN1OFR with $$_JOB Food and Drug Administration, HHS § 606.60 compatibility testing, storage or dis- (9) The orderly conduction of all tribution of blood or blood components packaging, labeling and other finishing is conducted. operations. (b) Provide adequate lighting, ven- [40 FR 53532, Nov. 18, 1975, as amended at 49 tilation and screening of open windows FR 23833, June 8, 1984; 55 FR 11014, Mar. 26, 1990; 62 FR 53538, Oct. 15, 1997] and doors. (c) Provide adequate, clean, and con- venient handwashing facilities for per- Subpart C—Plant and Facilities sonnel, and adequate, clean, and con- venient toilet facilities for donors and § 606.40 Facilities. personnel. Drains shall be of adequate Facilities shall be maintained in a size and, where connected directly to a clean and orderly manner, and shall be sewer, shall be equipped with traps to of suitable size, construction and loca- prevent back-siphonage. tion to facilitate adequate cleaning, (d) Provide for safe and sanitary dis- maintenance and proper operations. posal for the following: The facilities shall: (1) Trash and items used during the (a) Provide adequate space for the collection, processing and compat- following when applicable: ibility testing of blood and blood com- (1) Private and accurate examina- ponents. tions of individuals to determine their (2) Blood and blood components not eligibility as blood donors. suitable for use or distribution. (2) The withdrawal of blood from do- [40 FR 53532, Nov. 18, 1975, as amended at 80 nors with minimal risk of contamina- FR 29895, May 22, 2015] tion, or exposure to activities and equipment unrelated to blood collec- Subpart D—Equipment tion. (3) The storage of blood or blood com- § 606.60 Equipment. ponents pending completion of tests. (a) Equipment used in the collection, (4) The quarantine storage of blood or processing, compatibility testing, stor- blood components in a designated loca- age and distribution of blood and blood tion pending repetition of those tests components shall be maintained in a that initially gave questionable sero- clean and orderly manner and located logical results. so as to facilitate cleaning and mainte- (5) The storage of finished products nance. The equipment shall be ob- prior to distribution. served, standardized and calibrated on (6) The quarantine storage, handling a regularly scheduled basis as pre- and disposition of products and re- scribed in the Standard Operating Pro- agents not suitable for use.
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