[Code of Federal Regulations]

[Title 40, Volume 23]

[Revised as of July 1, 2005]

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

[CITE: 40CFR160.31]



[Page 146]

 

                   TITLE 40--PROTECTION OF ENVIRONMENT

 

         CHAPTER I--ENVIRONMENTAL PROTECTION AGENCY (CONTINUED)

 

PART 160_GOOD LABORATORY PRACTICE STANDARDS--Table of Contents

 

                  Subpart B_Organization and Personnel

 

Sec. 160.31  Testing facility management.



    For each study, testing facility management shall:

    (a) Designate a study director as described in Sec. 160.33 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. 160.35.

    (d) Assure that test, control, and reference substances 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.