[Code of Federal Regulations]
[Title 21, Volume 7]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR600.12]

[Page 11]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 600--BIOLOGICAL PRODUCTS: GENERAL--Table of Contents
 
                   Subpart B--Establishment Standards
 
Sec. 600.12  Records.

    (a) Maintenance of records. Records shall be made, concurrently with 
the performance, of each step in the manufacture and distribution of 
products, in such a manner that at any time successive steps in the 
manufacture and distribution of any lot may be traced by an inspector. 
Such records shall be legible and indelible, shall identify the person 
immediately responsible, shall include dates of the various steps, and 
be as detailed as necessary for clear understanding of each step by one 
experienced in the manufacture of products.
    (b) Records retention--(1) General. Records shall be retained for 
such interval beyond the expiration date as is necessary for the 
individual product, to permit the return of any clinical report of 
unfavorable reactions. The retention period shall be no less than five 
years after the records of manufacture have been completed or six months 
after the latest expiration date for the individual product, whichever 
represents a later date.
    (2) Records of recall. Complete records shall be maintained 
pertaining to the recall from distribution of any product upon 
notification by the Director, Center for Biologics Evaluation and 
Research, to recall for failure to conform with the standards prescribed 
in the regulations of this subchapter, because of deterioration of the 
product or for any other factor by reason of which the distribution of 
the product would constitute a danger to health.
    (3) Suspension of requirement for retention. The Director, Center 
for Biologics Evaluation and Research, may authorize the suspension of 
the requirement to retain records of a specific manufacturing step upon 
a showing that such records no longer have significance for the purposes 
for which they were made: Provided, That a summary of such records shall 
be retained.
    (c) Records of sterilization of equipment and supplies. Records 
relating to the mode of sterilization, date, duration, temperature and 
other conditions relating to each sterilization of equipment and 
supplies used in the processing of products shall be made by means of 
automatic recording devices or by means of a system of recording which 
gives equivalent assurance of the accuracy and reliability of the 
record. Such records shall be maintained in a manner that permits an 
identification of the product with the particular manufacturing process 
to which the sterilization relates.
    (d) Animal necropsy records. A necropsy record shall be kept on each 
animal from which a biological product has been obtained and which dies 
or is sacrificed while being so used.
    (e) Records in case of divided manufacturing responsibility. If two 
or more establishments participate in the manufacture of a product, the 
records of each such establishment must show plainly the degree of its 
responsibility. In addition, each participating manufacturer shall 
furnish to the manufacturer who prepares the product in final form for 
sale, barter or exchange, a copy of all records relating to the 
manufacturing operations performed by such participating manufacturer 
insofar as they concern the safety, purity and potency of the lots of 
the product involved, and the manufacturer who prepares the product in 
final form shall retain a complete record of all the manufacturing 
operations relating to the product.

[38 FR 32048, Nov. 20, 1973, as amended at 49 FR 23833, June 8, 1984; 55 
FR 11013, Mar. 26, 1990]