[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: 21CFR58.35]
 
[Page 312-313]
 
                        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
 
[[Page 313]]
 
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 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]