[Code of Federal Regulations]

[Title 21, Volume 1]

[Revised as of April 1, 2006]

From the U.S. Government Printing Office via GPO Access

[CITE: 21CFR58.105]



[Page 309]

 

                        TITLE 21--FOOD AND DRUGS

 

CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 

                                SERVICES

 

PART 58_GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIES

--Table of Contents

 

                   Subpart F_Test and Control Articles

 

Sec.  58.105  Test and control article characterization.





    (a) The identity, strength, purity, and composition or other 

characteristics which will appropriately define the test or control 

article shall be determined for each batch and shall be documented. 

Methods of synthesis, fabrication, or derivation of the test and control 

articles shall be documented by the sponsor or the testing facility. In 

those cases where marketed products are used as control articles, such 

products will be characterized by their labeling.

    (b) The stability of each test or control article shall be 

determined by the testing facility or by the sponsor either: (1) Before 

study initiation, or (2) concomitantly according to written standard 

operating procedures, which provide for periodic analysis of each batch.

    (c) Each storage container for a test or control article shall be 

labeled by name, chemical abstract number or code number, batch number, 

expiration date, if any, and, where appropriate, storage conditions 

necessary to maintain the identity, strength, purity, and composition of 

the test or control article. Storage containers shall be assigned to a 

particular test article for the duration of the study.

    (d) For studies of more than 4 weeks' duration, reserve samples from 

each batch of test and control articles shall be retained for the period 

of time provided by Sec.  58.195.



[43 FR 60013, Dec. 22, 1978, as amended at 52 FR 33781, Sept. 4, 1987; 

67 FR 9585, Mar. 4, 2002]