[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: 21CFR606.160]

[Page 51-53]
 
                        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 I--Records and Reports
 
Sec. 606.160  Records.


    (a)(1) Records shall be maintained concurrently with the performance 
of each significant step in the collection, processing, compatibility 
testing, storage and distribution of each unit of blood and blood 
components so that all steps can be clearly traced. All records shall be 
legible and indelible, and shall

[[Page 52]]

identify the person performing the work, include dates of the various 
entries, show test results as well as the interpretation of the results, 
show the expiration date assigned to specific products, and be as 
detailed as necessary to provide a complete history of the work 
performed.
    (2) Appropriate records shall be available from which to determine 
lot numbers of supplies and reagents used for specific lots or units of 
the final product.
    (b) Records shall be maintained that include, but are not limited 
to, the following when applicable:
    (1) Donor records:
    (i) Donor selection, including medical interview and examination and 
where applicable, informed consent.
    (ii) Permanent and temporary deferrals for health reasons including 
reason(s) for deferral.
    (iii) Donor adverse reaction complaints and reports, including 
results of all investigations and followup.
    (iv) Therapeutic bleedings, including signed requests from attending 
physicians, the donor's disease and disposition of units.
    (v) Immunization, including informed consent, identification of the 
antigen, dosage and route of administration.
    (vi) Blood collection, including identification of the phlebotomist.
    (vii) Records to relate the donor with the unit number of each 
previous donation from that donor.
    (viii) Records of quarantine, notification, testing, and disposition 
performed pursuant to Secs. 610.46 and 610.47 of this chapter.
    (2) Processing records:
    (i) Blood processing, including results and interpretation of all 
tests and retests.
    (ii) Component preparation, including all relevant dates and times.
    (iii) Separation and pooling of recovered plasma.
    (iv) Centrifugation and pooling of source plasma.
    (v) Labeling, including initials of the person(s) performing the 
procedure.
    (3) Storage and distribution records:
    (i) Distribution and disposition, as appropriate, of blood and blood 
products.
    (ii) Visual inspection of whole blood and red blood cells during 
storage and immediately before distribution.
    (iii) Storage temperature, including initialed temperature recorder 
charts.
    (iv) Reissue, including records of proper temperature maintenance.
    (v) Emergency release of blood, including signature of requesting 
physician obtained before or after release.
    (4) Compatibility test records:
    (i) Results of all compatibility tests, including crossmatching, 
testing of patient samples, antibody screening and identification.
    (ii) Results of confirmatory testing.
    (5) Quality control records:
    (i) Calibration and standardization of equipment.
    (ii) Performance checks of equipment and reagents.
    (iii) Periodic check on sterile technique.
    (iv) Periodic tests of capacity of shipping containers to maintain 
proper temperature in transit.
    (v) Proficiency test results.
    (6) Transfusion reaction reports and complaints, including records 
of investigations and followup.
    (7) General records:
    (i) Sterilization of supplies and reagents prepared within the 
facility, including date, time interval, temperature and mode.
    (ii) Responsible personnel.
    (iii) Errors and accidents.
    (iv) Maintenance records for equipment and general physical plant.
    (v) Supplies and reagents, including name of manufacturer or 
supplier, lot numbers, expiration date and date of receipt.
    (vi) Disposition of rejected supplies and reagents used in the 
collection, processing and compatibility testing of blood and blood 
components.
    (c) A donor number shall be assigned to each accepted donor, which 
relates the unit of blood collected to that donor, to his medical 
record, to any component or blood product from that donor's unit of 
blood, and to all records describing the history and ultimate 
disposition of these products.
    (d) Records shall be retained for such interval beyond the 
expiration date for the blood or blood component as necessary to 
facilitate the reporting of

[[Page 53]]

any unfavorable clinical reactions. The retention period shall be no 
less than 5 years after the records of processing have been completed or 
6 months after the latest expiration date for the individual product, 
whichever is a later date. When there is no expiration date, records 
shall be retained indefinitely.
    (e) A record shall be available from which unsuitable donors may be 
identified so that products from such individuals will not be 
distributed.

[40 FR 53532, Nov. 18, 1975, as amended at 61 FR 47422, Sept. 9, 1996; 
64 FR 45371, Aug. 19, 1999]

    Effective Date Note: At 65 FR 66635, Nov. 7, 2000, Sec. 606.160 was 
amended by revising paragraph (b)(7)(iii), effective May 7, 2000. At 65 
FR 67477, Nov. 9, 2000, the effective date was corrected to read May 7, 
2001. For the convenience of the user, the revised text is set forth as 
follows:

Sec. 606.160  Records.

                                * * * * *

    (b) * * *
    (7) * * *
    (iii) Biological product deviations.

                                * * * * *