Food and Drug Administration, HHS Pt. 58
§56.122Public disclosure of informa-tion regarding revocation.
A determination that the Food and Drug Administration has disqualified an institution and the administrative record regarding that determination are disclosable to the public under part 20.
§56.123Reinstatement of an IRB or an institution.
An IRB or an institution may be re-instated if the Commissioner deter-mines, upon an evaluation of a written submission from the IRB or institution that explains the corrective action that the institution or IRB plans to take, that the IRB or institution has provided adequate assurance that it will operate in compliance with the standards t forth in this part. Notifi-cation of reinstatement shall be pro-vided to all persons notified under §56.121(c).
§56.124Actions alternative or addi-tional to disqualification. Disqualification of an IRB or of an institution is independent of, and nei-ther in lieu of nor a precondition to, other proceedings or actions authorized by the act. The Food and Drug Admin-istration may, at any time, through the Department of Justice institute any appropriate judicial proceedings (civil or criminal) and any other appro-priate regul
atory action, in addition to or in lieu of, and before, at the time of, or after, disqualification. The agency may also refer pertinent matters to an-other Federal, State, or local govern-ment agency for any action that that agency determines to be appropriate. PART 58—GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIES
Subpart A—General Provisions
Sec.
58.1Scope.
58.3Definitions.
58.10Applicability to studies performed
under grants and contracts.
trust58.15Inspection of a testing facility. Subpart B—Organization and Personnel 58.29Personnel.58.31Testing facility management.
ld是什么意思58.33Study director.
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58.35Quality assurance unit.
Subpart C—Facilities
58.41General.
58.43Animal care facilities.
58.45Animal supply facilities.
58.47Facilities for handling test and con-
trol articles.
58.49Laboratory operation areas.
58.51Specimen and data storage facilities.
Subpart D—Equipment
58.61Equipment design.
58.63Maintenance and calibration of equip-
ment.
Subpart E—Testing Facilities Operation
58.81Standard operating procedures.
58.83Reagents and solutions.
58.90Animal care.
Subpart F—Test and Control Articles
58.105Test and control article characteriza-
tion.
58.107Test and control article handling. 58.113Mixture of articles with carriers. Subpart G—Protocol for and Conduct of a Nonclinical Laboratory Study
58.120Protocol.
58.130Conduct of a nonclinical laboratory
study.
Subparts H–I[Rerved]
Subpart J—Records and Reports
58.185Reporting of nonclinical laboratory
study results.
58.190Storage and retrieval of records and
data.
58.195Retention of records.
Subpart K—Disqualification of Testing
Facilities
58.200Purpo.
58.202Grounds for disqualification.
58.204Notice of and opportunity for hearing
on propod disqualification.
58.206Final order on disqualification.
58.210Actions upon disqualification.
58.213Public disclosure of information re-
garding disqualification.
58.215Alternative or additional actions to
disqualification.
58.217Suspension or termination of a test-
loans
ing facility by a sponsor.
58.219Reinstatement of a disqualified test-
ing facility.
21 CFR Ch. I (4–1–00 Edition)§58.1
A UTHORITY: 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.
S OURCE: 43 FR 60013, Dec. 22, 1978, unless otherwi noted.
Subpart A—General Provisions
§58.1Scope.
(a) This part prescribes good labora-tory practices for conducting nonclin-ical laboratory studies that support or are intended to support applications for rearch or marketing permits for products regulated by the Food and Drug Administration, including food and color additives, animal food addi-t
nariives, human and animal drugs, med-ical devices for human u, biological products, and electronic products. Compliance with this part is intended to assure the quality and integrity of the safety data filed pursuant to c-tions 406, 408, 409, 502, 503, 505, 506, 510, 512–516, 518–520, 721, and 801 of the Fed-eral Food, Drug, and Cosmetic Act and ctions 351 and 354–360F of the Public Health Service Act.
(b) References in this part to regu-latory ctions of the Code of Federal Regulations are to chapter I of title 21, unless otherwi noted.
[43 FR 60013, Dec. 22, 1978, as amended at 52 FR 33779, Sept. 4, 1987; 64 FR 399, Jan. 5, 1999]§58.3Definitions.
As ud in this part, the following terms shall have the meanings speci-fied:
(a) Act means the Federal Food, Drug, and Cosmetic Act, as amended (cs. 201–902, 52 Stat. 1040 et q., as amended (21 U.S.C. 321–392)).
(b) Test article means any food addi-tive, color additive, drug, biological product, electronic product, medical device for human u, or any other ar-ticle subject to regulation under the act or under ctions 351 and 354–360F of the Public Health Service Act.
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(c) Control article means any food ad-ditive, color additive, drug, biological product, electronic product, medical device for human u, or any article other than a test article, feed, or water that is administered to the test system in the cour of a nonclinical labora-tory study for the purpo of estab-lishing a basis for comparison with the test article.
(d) Nonclinical laboratory study means in vivo or in vitro experiments in which test articles are studied prospec-tively in test systems under laboratory conditions to determine their safety. The term does not include studies uti-lizing human subjects or clinical stud-ies or field trials in animals. The term does not include basic exploratory studies carried out to determine whether a test article has any poten-tial utility or to determine physical or chemical characteristics of a test arti-cle.
(e) Application for rearch or mar-keting permit includes:
(1) A color additive petition, de-scribed in part 71.
(2) A food additive petition, described in parts 171 and 571.
(3) Data and information regarding a substance submitted as part of the pro-cedures for establishing that a sub-stance is generally recognized as safe for u, which u results or may rea-sonably be e
xpected to result, directly or indirectly, in its becoming a compo-nent or otherwi affecting the charac-teristics of any food, described in §§170.35 and 570.35.
(4) Data and information regarding a food additive submitted as part of the procedures regarding food additives permitted to be ud on an interim basis pending additional study, de-scribed in §180.1.
(5) An investigational new drug appli-cation, described in part 312 of this chapter.
(6) A new drug application, described in part 314.
(7) Data and information regarding an over-the-counter drug for human u, submitted as part of the proce-dures for classifying such drugs as gen-erally recognized as safe and effective and not misbranded, described in part 330.
(8) Data and information about a sub-stance submitted as part of the proce-dures for establishing a tolerance for unavoidable contaminants in food and food-packaging materials, described in parts 109 and 509.
(9) Data and information regarding an antibiotic drug submitted as part of the procedures for issuing,
amending,
Food and Drug Administration, HHS§58.3
or repealing regulations for such drugs, described in §314.300 of this chapter. (10) A Notice of Claimed Investigational Exemption for a New Animal Drug, de-scribed in part 511.
(11) A new animal drug application, de-scribed in part 514.
(12) [Rerved]
(13) An application for a biologics li-cen, described in part 601 of this chap-ter.
(14) An application for an investiga-tional device exemption, described in part 812.
(15) An Application for Premarket Ap-proval of a Medical Device, described in ction 515 of the act.
(16) A Product Development Protocol for
a Medical Device, described in ction 515 of the act.
(17) Data and information regarding a medical device submitted as part of the procedures for classifying such devices, described in part 860.
(18) Data and information regarding a medical device submitted as part of the procedures for establishing, amending, or repealing a performance standard for such devices, described in part 861.
(19) Data and information regarding an electronic product submitted as part of the procedures for obtaining an exemption from notification of a radi-ation safety defect or failure of compli-ance with a radiation safety perform-ance standard, described in subpart D of part 1003.
(20) Data and information regarding an electronic product submitted as part of the procedures for establishing, amending, or repealing a standard for such product, described in ction 358 of the Public Health Service Act.
(21) Data and information regarding an electronic product submitted as part of the procedures for obtaining a variance from any electronic product performance standard as described in §1010.4.
(22) Data and information regarding an electronic product submitted as part of the procedures for gr
anting, amending, or extending an exemption from any electronic product perform-ance standard, as described in §1010.5.conscience
(f) Sponsor means:
(1) A person who initiates and sup-ports, by provision of financial or other resources, a nonclinical laboratory study;
(2) A person who submits a nonclin-ical study to the Food and Drug Ad-ministration in support of an applica-tion for a rearch or marketing per-mit; or
(3) A testing facility, if it both initi-ates and actually conducts the study. (g) Testing facility means a person who actually conducts a nonclinical laboratory study, i.e., actually us the test article in a test system. Testing fa-cility includes any establishment re-quired to register under ction 510 of the act that conducts nonclinical lab-oratory studies and any consulting lab-oratory described in ction 704 of the act that conducts such studies. Testing facility encompass only tho oper-ational units that are being or have been ud to conduct nonclinical lab-oratory studies.lss
(h) Person includes an individual, partnership, corporation, association, scientific or academic establishment, government agency, or organizational unit thereof, and any other legal enti-ty.
(i) Test system means any animal, plant, microorganism, or subparts thereof to which the test or control ar-ticle is administered or added for study. Test system also includes appro-priate groups or components of the sys-tem not treated with the test or con-trol articles.
(j) Specimen means any material de-rived from a test system for examina-tion or analysis.
(k) Raw data means any laboratory worksheets, records, memoranda, notes, or exact copies thereof, that are the result of original obrvations and activities of a nonclinical laboratory study and are necessary for the recon-struction and evaluation of the report of that study. In the event that exact transcripts of raw data have been pre-pared (e.g., tapes which have been tran-scribed verbatim, dated, and verified accurate by signature), the exact copy or exact transcript may be substituted for the original source as raw data. Raw data may include photographs,
21 CFR Ch. I (4–1–00 Edition)§58.10
microfilm or microfiche copies, com-puter printouts, magnetic media, in-cluding dictated obrvations, and re-corded data from automated instru-ments.
(l) Quality assurance unit means any person or organizational element, ex-cept the study director, de
signated by testing facility management to per-form the duties relating to quality as-surance of nonclinical laboratory stud-ies.
(m) Study director means the indi-vidual responsible for the overall con-duct of a nonclinical laboratory study. (n) Batch means a specific quantity or lot of a test or control article that has been characterized according to §58.105(a).
(o) Study initiation date means the date the protocol is signed by the study director.
(p) Study completion date means the date the final report is signed by the study director.
[43 FR 60013, Dec. 22, 1978, as amended at 52 FR 33779, Sept. 4, 1987; 54 FR 9039, Mar. 3, 1989; 64 FR 56448, Oct. 20, 1999]
§58.10Applicability to studies per-formed under grants and contracts. When a sponsor conducting a non-clinical laboratory study intended to be submitted to or reviewed by the Food and Drug Administration utilizes the rvices of a consulting laboratory, contractor, or grantee to perform an analysis or other rvice, it shall no-tify the consulting laboratory, con-tractor, or grantee that the rvice is part of a nonclinical laboratory study that must be conducted in compliance with the provisions of this part.
§58.15Inspection of a testing facility.
(a) A testing facility shall permit an authorized employee of the Food and Drug Administration, at reasonable times and in a reasonable manner, to inspect the facility and to inspect (and in the ca of records also to copy) all records and specimens required to be maintained regarding studies within the scope of this part. The records in-spection and copying requirements shall not apply to quality assurance unit records of findings and problems, or to actions recommended and taken.
(b) The Food and Drug Administra-tion will not consider a nonclinical lab-oratory study in support of an applica-tion for a rearch or marketing per-mit if the testing facility refus to permit inspection. The determination that a nonclinical laboratory study will not be considered in support of an application for a rearch or marketing permit does not, however, relieve the applicant for such a permit of any obli-gation under any applicable statute or regulation to submit the results of the study to the Food and Drug Adminis-tration.
Subpart B—Organization and
Personnel
§58.29Personnel.
(a) Each individual engaged in the conduct of or responsible for the super-vision of a nonclinical laboratory study shall have education, training, and ex-perience, or combination thereof, to enable that individual to perform the assigned functions.
(b) Each testing facility shall main-tain 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 pre-cautions designed to avoid contamina-tion of test and control articles and test systems.
(e) Personnel engaged in a nonclin-ical laboratory study shall wear cloth-ing appropriate for the duties they per-form. Such clothing shall be changed as often as necessary to prevent micro-biological, 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 adverly affect the quality and integri
请家教一小时多少钱ty 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 adverly affect the study until
Food and Drug Administration, HHS§58.35
the condition is corrected. All per-sonnel shall be instructed to report to their immediate supervisors any health or medical conditions that may reason-ably be considered to have an adver effect on a nonclinical laboratory study.
§58.31Testing facility management. For each nonclinical laboratory study, testing facility management shall:
(a) Designate a study director as de-scribed 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 as-surance unit as described in §58.35. (d) Assure that test and control arti-cles or mixtures have been appro-priately tested for identity, strength, purity, stability, and uniformity, as applicable.
(e) Assure that personnel, resources, facilities, equipment, materials, and methodologies are available as sched-uled.
(f) Assure that personnel clearly un-derstand the functions they are to per-form.
(g) Assure that any deviations from the regulations reported by the qual-ity assurance unit are communicated to the study director and corrective ac-tions are taken and documented.
[43 FR 60013, Dec. 22, 1978, as amended at 52 FR 33780, Sept. 4, 1987]
§58.33Study director.
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 direc-tor. The study director has overall re-sponsibility for the technical conduct of the study, as well as for the inter-pretation, analysis, documentation and reporting of results, and reprents 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 obrvations of unanticipated re-spons of the test system are accu-rately recorded and verified.
(c) Unforeen 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, pro-tocols, specimens, and final reports are transferred to the archives during or at the clo of the study.
英语好文章[43 FR 60013, Dec. 22, 1978; 44 FR 17657, Mar. 23, 1979]
§58.35Quality 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 facili-ties, equipment, personnel, methods, practices, records, and controls are in conformance with the regulations in this part. For any given study, the qu
ality assurance unit shall be entirely parate 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 lab-oratory studies conducted at the test-ing facility indexed by test article and containing the test system, nature of study, date study was initiated, cur-rent status of each study, identity of the sponsor, and name of the study di-rector.
(2) Maintain copies of all protocols pertaining to all nonclinical laboratory studies for which the unit is respon-sible.
(3) Inspect each nonclinical labora-tory study at intervals adequate to as-sure 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 pha or gment of the study inspected, the person per-forming the inspection, findings and problems, action recommended and taken to resolve existing problems, and any scheduled date for reinspection. Any problems found during the cour
