[Code of Federal Regulations]
[Title 21, Volume 7]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR606.100]

[Page 46-47]
 
                        TITLE 21--FOOD AND DRUGS
 
          DEPARTMENT OF HEALTH AND HUMAN SERVICES--(Continued)
 
PART 606--CURRENT GOOD MANUFACTURING PRACTICE FOR BLOOD AND BLOOD COMPONENTS--Table of Contents
 
               Subpart F--Production and Process Controls
 
Sec. 606.100  Standard operating procedures.


    (a) In all instances, except clinical investigations, standard 
operating procedures shall comply with published additional standards in 
part 640 of this chapter for the products being processed; except that, 
references in part 640 relating to licenses, licensed establishments and 
submission of material or data to or approval by the Director, Center 
for Biologics Evaluation and Research, are not applicable to 
establishments not subject to licensure under section 351 of the Public 
Health Service Act.
     (b) Written standard operating procedures shall be maintained and 
shall include all steps to be followed in the collection, processing, 
compatibility testing, storage, and distribution of blood and blood 
components for transfusion and further manufacturing purposes. Such 
procedures shall be available to the personnel for use in the areas 
where the procedures are performed. The written standard operating 
procedures shall include, but are not limited to, descriptions of the 
following, when applicable:
    (1) Criteria used to determine donor suitability, including 
acceptable medical history criteria.
    (2) Methods of performing donor qualifying tests and measurements, 
including minimum and maximum values for a test or procedure when a 
factor in determining acceptability.
    (3) Solutions and methods used to prepare the site of phlebotomy to 
give maximum assurance of a sterile container of blood.
    (4) Method of accurately relating the product(s) to the donor.
    (5) Blood collection procedure, including in-process precautions 
taken to measure accurately the quantity of blood removed from the 
donor.
    (6) Methods of component preparation, including any time 
restrictions for specific steps in processing.
     (7) All tests and repeat tests performed on blood and blood 
components during manufacturing.
    (8) Pretransfusion testing, where applicable, including precautions 
to be taken to identify accurately the recipient blood samples and 
crossmatched donor units.
    (9) Procedures for investigating adverse donor and recipient 
reactions.
    (10) Storage temperatures and methods of controlling storage 
temperatures for all blood products and reagents as prescribed in 
Secs. 600.15 and 610.53 of this chapter.
    (11) Length of expiration dates, if any, assigned for all final 
products as prescribed in Sec. 610.53 of this chapter.
    (12) Criteria for determining whether returned blood is suitable for 
reissue.
    (13) Procedures used for relating a unit of blood or blood component 
from the donor to its final disposition.
    (14) Quality control procedures for supplies and reagents employed 
in blood collection, processing and pretransfusion testing.
    (15) Schedules and procedures for equipment maintenance and 
calibration.
    (16) Labeling procedures, including safeguards to avoid labeling 
mixups.
    (17) Procedures of plasmapheresis, plateletpheresis, and 
leukapheresis, if performed, including precautions to be taken to ensure 
reinfusion of a donor's own cells.
     (18) Procedures for preparing recovered plasma, if performed, 
including details of separation, pooling, labeling, storage, and 
distribution.
    (19) Procedures in accordance with Sec. 610.46 of this chapter to 
look at prior donations of Whole Blood, blood components, Source Plasma 
and Source Leukocytes from a donor who has donated blood and 
subsequently tests repeatedly reactive for antibody to human 
immunodeficiency virus (HIV) or otherwise is determined to be unsuitable 
when tested in accordance with Sec. 610.45 of this chapter. Procedures 
to quarantine in-house Whole Blood, blood components, Source Plasma and 
Source Leukocytes intended for further manufacture into injectable 
products that were obtained from such donors; procedures to notify 
consignees regarding the need to quarantine such products; procedures to 
determine the suitability for release of such products from quarantine; 
procedures to notify consignees of Whole Blood, blood components, Source 
Plasma and Source

[[Page 47]]

Leukocytes from such donors of the results of the antibody testing of 
such donors; and procedures in accordance with Sec. 610.47 of this 
chapter to notify attending physicians so that transfusion recipients 
are informed that they may have received Whole Blood and, blood 
components at increased risk for transmitting human immunodeficiency 
virus.
    (c) All records pertinent to the lot or unit maintained pursuant to 
these regulations shall be reviewed before the release or distribution 
of a lot or unit of final product. The review or portions of the review 
may be performed at appropriate periods during or after blood 
collecting, processing, compatibility testing and storing. A thorough 
investigation, including the conclusions and followup, of any 
unexplained discrepancy or the failure of a lot or unit to meet any of 
its specifications shall be made and recorded.
     (d) In addition to the requirements of this subpart and in 
conformity with this section, any facility may utilize current standard 
operating procedures such as the manuals of the organizations, as long 
as such specific procedures are consistent with, and at least as 
stringent as, the requirements contained in this part.
    (1) American Association of Blood Banks.
    (2) American National Red Cross.
    (3) Other organizations or individual blood banks, subject to 
approval by the Director, Center for Biologics Evaluation and Research.

[40 FR 53532, Nov. 18, 1975, as amended at 49 FR 23833, June 8, 1984; 55 
FR 11013, Mar. 26, 1990; 61 FR 47422, Sept. 9, 1996; 64 FR 45370, Aug. 
19, 1999]