[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: 21CFR58.31]



[Page 305]

 

                        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 B_Organization and Personnel

 

Sec.  58.31  Testing facility management.



    For each nonclinical laboratory study, testing facility management 

shall:

    (a) Designate a study director as described in Sec.  58.33, before 

the study is initiated.

    (b) Replace the study director promptly if it becomes necessary to 

do so during the conduct of a study.

    (c) Assure that there is a quality assurance unit as described in 

Sec.  58.35.

    (d) Assure that test and control articles or mixtures have been 

appropriately tested for identity, strength, purity, stability, and 

uniformity, as applicable.

    (e) Assure that personnel, resources, facilities, equipment, 

materials, and methodologies are available as scheduled.

    (f) Assure that personnel clearly understand the functions they are 

to perform.

    (g) Assure that any deviations from these regulations reported by 

the quality assurance unit are communicated to the study director and 

corrective actions are taken and documented.



[43 FR 60013, Dec. 22, 1978, as amended at 52 FR 33780, Sept. 4, 1987]