[Code of Federal Regulations]

[Title 40, Volume 23]

[Revised as of July 1, 2006]

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

[CITE: 40CFR160.35]



[Page 146-147]

 

                   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.  160.35  Quality assurance unit.



    (a) A testing facility shall have a quality assurance unit which 

shall be responsible for monitoring each study to assure management that 

the facilities, equipment, personnel, methods, practices, records, and 

controls are in conformance with the regulations in this part. For any 

given study, the quality assurance unit shall be entirely separate from 

and independent of the personnel engaged in the direction and conduct of 

that study. The quality assurance unit shall conduct inspections and 

maintain records appropriate to the study.

    (b) The quality assurance unit shall:

    (1) Maintain a copy of a master schedule sheet of all studies 

conducted at the testing facility indexed by test substance, and 

containing the test system, nature of study, date study was initiated, 

current status of each study, identity of the sponsor, and name of the 

study director.

    (2) Maintain copies of all protocols pertaining to all studies for 

which the unit is responsible.

    (3) Inspect each study at intervals adequate to ensure the integrity 

of the study and maintain written and properly signed records of each 

periodic inspection showing the date of the inspection, the study 

inspected, the phase or segment of the study inspected, the person 

performing the inspection, findings and problems, action recommended and 

taken to resolve existing problems, and any scheduled date for 

reinspection. Any problems which are likely to affect study integrity 

found during the course of an inspection shall be brought to the 

attention of the study director and management immediately.



[[Page 147]]



    (4) Periodically submit to management and the study director written 

status reports on each study, noting any problems and the corrective 

actions taken.

    (5) Determine that no deviations from approved protocols or standard 

operating procedures were made without proper authorization and 

documentation.

    (6) Review the final study report to assure that such report 

accurately describes the methods and standard operating procedures, and 

that the reported results accurately reflect the raw data of the study.

    (7) Prepare and sign a statement to be included with the final study 

report which shall specify the dates inspections were made and findings 

reported to management and to the study director.

    (c) The responsibilities and procedures applicable to the quality 

assurance unit, the records maintained by the quality assurance unit, 

and the method of indexing such records shall be in writing and shall be 

maintained. These items including inspection dates, the study inspected, 

the phase or segment of the study inspected, and the name of the 

individual performing the inspection shall be made available for 

inspection to authorized employees or duly designated representatives of 

EPA or FDA.

    (d) An authorized employee or a duly designated representative of 

EPA or FDA shall have access to the written procedures established for 

the inspection and may request testing facility management to certify 

that inspections are being implemented, performed, documented, and 

followed up in accordance with this paragraph.