[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR58.35]

[Page 307-308]
 
                        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.  58.35  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.
    (b) The quality assurance unit shall:
    (1) Maintain a copy of a master schedule sheet of all nonclinical 
laboratory studies conducted at the testing facility indexed by test 
article 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 nonclinical 
laboratory studies for which the unit is responsible.
    (3) Inspect each nonclinical laboratory study at intervals adequate 
to assure 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 found during the course of 
an inspection which are likely to affect study integrity shall be 
brought to the attention of the study director and management 
immediately.
    (4) Periodically submit to management and the study director written 
status reports on each study, noting

[[Page 308]]

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 
nonclinical laboratory 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 of the Food and Drug Administration.
    (d) A designated representative of the Food and Drug Administration 
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.

[43 FR 60013, Dec. 22, 1978, as amended at 52 FR 33780, Sept. 4, 1987; 
67 FR 9585, Mar. 4, 2002]