This electronic document was downloaded from the GPO web site, September 2002,
and is provided for information purposes only. The Code of Federal Regulations,
Title 21, is updated each year in early summer.
The most current version of the regulations may be found at the
GPO web site or from the current
printed version.
[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR58.105]
[Page 316]
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]