美国《药品非临床质量管理规范》英文版.docx

1、美国药品非临床质量管理规范英文版TITLE 21-FOOD AND DRUGSCHAPTER I-FOOD AND DRUG ADMINISTRATIONDEPARTMENT OF HEALTH AND HUMAN SERVICES SUBCHAPTER A-GENERAL Subpart A-General ProvisionsSec. 58.1 Scope.(a) This part prescribes good laboratory practices for conducting nonclinical laboratory studies that support or are i

2、ntended to support applications for research or marketing permits for products regulated by the Food and Drug Administration, including food and color additives, animal food additives, human and animal drugs, medical devices for human use, biological products, and electronic products. Compliance wit

3、h this part is intended to assure the quality and integrity of the safety data filed pursuant to sections 406, 408, 409, 502, 503, 505, 506, 510, 512-516, 518-520, 721, and 801 of the Federal Food, Drug, and Cosmetic Act and sections 351 and 354-360F of the Public Health Service Act.(b) References i

4、n this part to regulatory sections of the Code of Federal Regulations are to chapter I of title 21, unless otherwise noted.43 FR 60013, Dec. 22, 1978, as amended at 52 FR 33779, Sept. 4, 1987; 64 FR 399, Jan. 5, 1999Sec. 58.3 Definitions.As used in this part, the following terms shall have the meani

5、ngs specified:(a)Act means the Federal Food, Drug, and Cosmetic Act, as amended (secs. 201-902, 52 Stat. 1040et seq., as amended (21 U.S.C. 321-392).(b)Test article means any food additive, color additive, drug, biological product, electronic product, medical device for human use, or any other artic

6、le subject to regulation under the act or under sections 351 and 354-360F of the Public Health Service Act.(c)Control article means any food additive, color additive, drug, biological product, electronic product, medical device for human use, or any article other than a test article, feed, or water

7、that is administered to the test system in the course of a nonclinical laboratory study for the purpose of establishing 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 prospectively in test systems

8、under laboratory conditions to determine their safety. The term does not include studies utilizing human subjects or clinical studies or field trials in animals. The term does not include basic exploratory studies carried out to determine whether a test article has any potential utility or to determ

9、ine physical or chemical characteristics of a test article.(e)Application for research or marketing permit includes:(1) A color additive petition, described 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

10、 procedures for establishing that a substance is generally recognized as safe for use, which use results or may reasonably be expected to result, directly or indirectly, in its becoming a component or otherwise affecting the characteristics of any food, described in 170.35 and 570.35.(4) Data and in

11、formation regarding a food additive submitted as part of the procedures regarding food additives permitted to be used on an interim basis pending additional study, described in 180.1.(5) An investigational new drug application, described in part 312 of this chapter.(6) Anew drug application, describ

12、ed in part 314.(7) Data and information regarding an over-the-counter drug for human use, submitted as part of the procedures for classifying such drugs as generally recognized as safe and effective and not misbranded, described in part 330.(8) Data and information about a substance submitted as par

13、t of the procedures for establishing a tolerance for unavoidable contaminants in food and food-packaging materials, described in parts 109 and 509.(9) Reserved(10) A Notice of Claimed Investigational Exemption for a New Animal Drug, described in part 511.(11) Anew animal drug application, described

14、in part 514.(12) Reserved(13) An application for a biologics license, described in part 601 of this chapter.(14) An application for an investigational device exemption, described in part 812.(15) An Application for Premarket Approval of a Medical Device, described in section 515 of the act.(16) A Pr

15、oduct Development Protocol for a Medical Device, described in section 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

16、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 radiation safety defect or failure of

17、 compliance with a radiation safety performance 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 section 358 of the Public Hea

18、lth 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

19、 for granting, amending, or extending an exemption from any electronic product performance standard, as described in 1010.5.(23) A premarket notification for a food contact substance, described in part 170, subpart D, of this chapter.(f)Sponsor means:(1) A person who initiates and supports, by provi

20、sion of financial or other resources, a nonclinical laboratory study;(2) A person who submits a nonclinical study to the Food and Drug Administration in support of an application for a research or marketing permit; or(3) A testing facility, if it both initiates and actually conducts the study.(g)Tes

21、ting facility means a person who actually conducts a nonclinical laboratory study, i.e., actually uses the test article in a test system. Testing facility includes any establishment required to register under section 510 of the act that conducts nonclinical laboratory studies and any consulting labo

22、ratory described in section 704 of the act that conducts such studies. Testing facility encompasses only those operational units that are being or have been used to conduct nonclinical laboratory studies.(h)Person includes an individual, partnership, corporation, association, scientific or academic

23、establishment, government agency, or organizational unit thereof, and any other legal entity.(i)Test system means any animal, plant, microorganism, or subparts thereof to which the test or control article is administered or added for study.Test system also includes appropriate groups or components o

24、f the system not treated with the test or control articles.(j)Specimen means any material derived from a test system for examination or analysis.(k)Raw data means any laboratory worksheets, records, memoranda, notes, or exact copies thereof, that are the result of original observations and activitie

25、s of a nonclinical laboratory study and are necessary for the reconstruction and evaluation of the report of that study. In the event that exact transcripts of raw data have been prepared (e.g., tapes which have been transcribed verbatim, dated, and verified accurate by signature), the exact copy or

26、 exact transcript may be substituted for the original source as raw data. Raw data may include photographs, microfilm or microfiche copies, computer printouts, magnetic media, including dictated observations, and recorded data from automated instruments.(l)Quality assurance unit means any person or

27、organizational element, except the study director, designated by testing facility management to perform the duties relating to quality assurance of nonclinical laboratory studies.(m)Study director means the individual responsible for the overall conduct of a nonclinical laboratory study.(n)Batch mea

28、ns 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

29、. 22, 1978, as amended at 52 FR 33779, Sept. 4, 1987; 54 FR 9039, Mar. 3, 1989; 64 FR 56448, Oct. 20, 1999; 67 FR 35729, May 21, 2002Sec. 58.10 Applicability to studies performed under grants and contracts.When a sponsor conducting a nonclinical laboratory study intended to be submitted to or review

30、ed by the Food and Drug Administration utilizes the services of a consulting laboratory, contractor, or grantee to perform an analysis or other service, it shall notify the consulting laboratory, contractor, or grantee that the service is part of a nonclinical laboratory study that must be conducted

31、 in compliance with the provisions of this part.Sec. 58.15 Inspection 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 case of recor

32、ds also to copy) all records and specimens required to be maintained regarding studies within the scope of this part. The records inspection 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 Administration will not consider a nonclinical laboratory study in support of an application for a research or marketing permit if the testing facility refuses to permit inspection. The determination that a nonclinical laboratory study will not be considered in suppo