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| [Code of Federal Regulations] |
| [Title 21, Volume 1] |
| [CITE: 21CFR58] |
TITLE 21--FOOD AND DRUGS CHAPTER I--FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER A - GENERAL
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| PART 58 | GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIES |
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Subpart B - Organization and Personnel
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(a) Each individual engaged in the conduct of or responsible for the supervision of a nonclinical laboratory study shall have education, training, and experience, or combination thereof, to enable that individual to perform the assigned functions.
(b) Each testing facility shall maintain a current summary of training and experience and job description for each individual engaged in or supervising the conduct of a nonclinical laboratory study.
(c) There shall be a sufficient number of personnel for the timely and proper conduct of the study according to the protocol.
(d) Personnel shall take necessary personal sanitation and health precautions designed to avoid contamination of test and control articles and test systems.
(e) Personnel engaged in a nonclinical laboratory study shall wear clothing appropriate for the duties they perform. Such clothing shall be changed as often as necessary to prevent microbiological, radiological, or chemical contamination of test systems and test and control articles.
(f) Any individual found at any time to have an illness that may adversely affect the quality and integrity of the nonclinical laboratory study shall be excluded from direct contact with test systems, test and control articles and any other operation or function that may adversely affect the study until the condition is corrected. All personnel shall be instructed to report to their immediate supervisors any health or medical conditions that may reasonably be considered to have an adverse effect on a nonclinical laboratory study.
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Sec. 58.31 Testing facility management.
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For each nonclinical laboratory study, testing facility management shall:
(a) Designate a study director as described in § 58.33, 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 § 58.35.
(d) Assure that test and control articles 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.
[43 FR 60013, Dec. 22, 1978, as amended at 52 FR 33780, Sept. 4, 1987]
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Sec. 58.33 Study director.
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For each nonclinical laboratory study, a scientist or other professional of appropriate education, training, and experience, or combination thereof, shall be identified as the study director. The study director has overall responsibility for the technical conduct of the study, as well as for the interpretation, analysis, documentation and reporting of results, and represents the single point of study control. The study director shall assure that:
(a) The protocol, including any change, is approved as provided by § 58.120 and is followed.
(b) All experimental data, including observations of unanticipated responses of the test system are accurately recorded and verified.
(c) Unforeseen circumstances that may affect the quality and integrity of the nonclinical laboratory study are noted when they occur, and corrective action is taken and documented.
(d) Test systems are as specified in the protocol.
(e) All applicable good laboratory practice regulations are followed.
(f) All raw data, documentation, protocols, specimens, and final reports are transferred to the archives during or at the close of the study.
[43 FR 60013, Dec. 22, 1978; 44 FR 17657, Mar. 23, 1979]
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Sec. 58.35 Quality assurance unit.
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(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 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]
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Authority: 21 U.S.C. 342, 346, 346a, 348, 351, 352, 353, 355, 360, 360b-360f, 360h-360j, 371, 379e, 381; 42 U.S.C. 216, 262, 263b-263n.
Source: 43 FR 60013, Dec. 22, 1978, unless otherwise noted.
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