[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: 21CFR58.35]



[Page 305-306]

 

                        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



[[Page 306]]



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]