21CFR210211cGMP中英对照版同名6532.docx

1、21CFR210211cGMP中英对照版同名653221 Code of Federal Regulations Parts210 and 211Part 210 - CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PROCESSING, PACKING, OR HOLDING OF DRUGS; GENERAL PART 211 - CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS210部分人用及兽用药品的生产、加工、包装或贮存的CGMP（概述）211部

2、分制剂药品的CGMPPart 210 - CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PROCESSING, PACKING, OR HOLDING OF DRUGS; GENERAL210.1 Status of current good manufacturing practice regulations.210.2 Applicability of current good manufacturing practice regulations.210.3 Definitions.AUTHORITY: Secs. 201, 5

3、01, 502, 505, 506, 507, 512, 701, 704 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321, 351, 352, 355, 356, 357, 360b, 371, 374).SOURCE: 43 FR 45076, Sept. 29, 1978, unless otherwise noted. 210.1 Status of current good manufacturing practice regulations.(a) The regulations set forth in thi

4、s part and in Parts 211 through 226 of this chapter contain the minimum current good manufacturing practice for methods to be used in, and the facilities or controls to be used for, the manufacture, processing, packing, or holding of a drug to assure that such drug meets the requirements of the act

5、as to safety, and has the identity and strength and meets the quality and purity characteristics that it purports or is represented to possess.(b) The failure to comply with any regulation set forth in this part and in Parts 211 through 226 of this chapter in the manufacture, processing, packing, or

6、 holding of a drug shall render such drug to be adulterated under section 501(a)(2)(B) of the act and such drug, as well as the person who is responsible for the failure to comply, shall be subject to regulatory action. 210.2 Applicability of current good manufacturing practice regulations.(a) The r

7、egulations in this part and in Parts 211 through 226 of this chapter as they may pertain to a drug and in Parts 600 through 680 of this chapter as they may pertain to a biological product for human use, shall be considered to supplement, not supersede, each other, unless the regulations explicitly p

8、rovide otherwise. In the event that it is impossible to comply with all applicable regulations in these parts, the regulations specifically applicable to the drug in question shall supersede the more general. (b) If a person engages in only some operations subject to the regulations in this part and

9、 in Parts 211 through 226 and Parts 600 through 680 of this chapter, and not in others, that person need only comply with those regulations applicable to the operations in which he or she is engaged. 210.3 Definitions.(a) The definitions and interpretations contained in section 201 of the act shall

10、be applicable to such terms when used in this part and in Parts 211 through 226 of this chapter.(b) The following definitions of terms apply to this part and to Parts 211 through 226 of this chapter. (1) Act means the Federal Food, Drug, and Cosmetic Act, as amended (21 U.S.C. 301 et seq.).(2) Batch

11、 means a specific quantity of a drug or other material that is intended to have uniform character and quality, within specified limits, and is produced according to a single manufacturing order during the same cycle of manufacture.(3) Component means any ingredient intended for use in the manufactur

12、e of a drug product, including those that may not appear in such drug product.(4) Drug product means a finished dosage form, for example, tablet, capsule, solution, etc., that contains an active drug ingredient generally, but not necessarily, in association with inactive ingredients. The term also i

13、ncludes a finished dosage form that does not contain an active ingredient but is intended to be used as a placebo.(5) Fiber means any particulate contaminant with a length at least three times greater than its width.(6)Non-fiber-releasing filter means any filter, which after any appropriate pretreat

14、ment such as washing or flushing, will not release fibers into the component or drug product that is being filtered. All filters composed of asbestos are deemed to be fiber-releasing filters.(7) Active ingredient means any component that is intended to furnish pharmacological activity or other direc

15、t effect in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body of man or other animals. The term includes those components that may undergo chemical change in the manufacture of the drug product and be present in the drug prod

16、uct in a modified form intended to furnish the specified activity or effect.(8) Inactive ingredient means any component other than an active ingredient.(9) In-process material means any material fabricated, compounded, blended, or derived by chemical reaction that is produced for, and used in, the p

17、reparation of the drug product.(10) Lot means a batch, or a specific identified portion of a batch, having uniform character and quality within specified limits; or, in the case of a drug product produced by continuous process, it is a specific identified amount produced in a unit of time or quantit

18、y in a manner that assures its having uniform character and quality within specified limits.(11) Lot number, control number, or batch number means any distinctive combination of letters, numbers, or symbols, or any combination of them, from which the complete history of the manufacture, processing,

19、packing, holding, and distribution of a batch or lot of drug product or other material can be determined.(12) Manufacture, processing, packing, or holding of a drug product includes packaging and labeling operations, testing, and quality control of drug products.(13) The term medicated feed means an

20、y Type B or Type C medicated feed as defined in 558.3 of this chapter. The feed contains one or more drugs as defined in section 201(g) of the act. The manufacture of medicated feeds is subject to the requirements of Part 225 of this chapter.(14) The term medicated premix means a Type A medicated ar

21、ticle as defined in 558.3 of this chapter. The article contains one or more drugs as defined in section 201(g) of the act. The manufacture of medicated premixes is subject to the requirements of Part 226 of this chapter.(15) Quality control unit means any person or organizational element designated

22、by the firm to be responsible for the duties relating to quality control.(16) Strength means: (I) The concentration of the drug substance (for example, weight/weight, weight/volume, or unit dose/volume basis), and/or(ii) The potency, that is, the therapeutic activity of the drug product as indicated

23、 by appropriate laboratory tests or by adequately developed and controlled clinical data (expressed, for example, in terms of units by reference to a standard).(17) Theoretical yield means the quantity that would be produced at any appropriate phase of manufacture, processing, or packing of a partic

24、ular drug product, based upon the quantity of components to be used, in the absence of any loss or error in actual production(18) Actual yield means the quantity that is actually produced at any appropriate phase of manufacture, processing, or packing of a particular drug product.(19) Percentage of

25、theoretical yield means the ratio of the actual yield (at any appropriate phase of manufacture, processing, or packing of a particular drug product) to the theoretical yield (at the same phase), stated as a percentage.(20) Acceptance criteria means the product specifications and acceptance/rejection

26、 criteria, such as acceptable quality level and unacceptable quality level, with an associated sampling plan, that are necessary for making a decision to accept or reject a lot or batch (or any other convenient subgroups of manufactured units).(21) Representative sample means a sample that consists

27、of a number of units that are drawn based on rational criteria such as random sampling and intended to assure that the sample accurately portrays the material being sampled.(22) Gang-printed labeling means labeling derived from a sheet of material on which more than one item of labeling is printed.4

28、3 FR 45076, Sept. 29, 1978, as amended at 51 FR 7389, Mar. 3, 1986; 58 FR 41353, Aug. 3, 1993EFFECTIVE DATE NOTE: At 58 FR 41353, Aug. 8, 1993, 210.3 was amended by adding paragraph (b)(22) effective Aug. 3, 1994.Part 211 -CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS (21 CFR Part

29、 211 As of April, 1996)Authority: Secs. 201, 501, 502, 505, 506, 507, 512, 701, 704 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321, 351, 352, 355, 356, 357, 360b, 371, 374). Source: 43 FR 45077, Sept. 29, 1978, unless otherwise noted. Subpart A-General Provisions 211.1 - Scope.211.3 - De

30、finitions.Subpart B-Organization and Personnel 211.22 - Responsibilities of quality control unit.211.25 - Personnel qualifications. 211.28 - Personnel responsibilities. 211.34 - Consultants.Subpart C-Buildings and Facilities211.42 - Design and construction features. 211.44 - Lighting. 211.46 - Venti

31、lation, air filtration, air heating and cooling.211.48 - Plumbing.211.50 - Sewage and refuse.211.52 - Washing and toilet facilities. 211.56 - Sanitation.211.58 - Maintenance. Subpart D-Equipment 211.63 - Equipment design, size, and location. 211.65 - Equipment construction. 211.67 - Equipment cleani

32、ng and maintenance. 211.68 - Automatic, mechanical, and electronic equipment.211.72 - Filters. Subpart E-Control of Components and Drug Product Containers and Closures211.80 - General requirements.211.82 - Receipt and storage of untested components, drug product containers, and closures. 211.84 - Testing and approval or rejection of components, drug product containers, and closures.211.86 - Use of approved components, drug product containers, and closures.211.87 - Retesting of approv