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CFR210/211原文件及中文翻译
Part 210 - Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of D General&- 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c（概述）211部分—制剂药品的cGMPPart 210 -Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of D General&Status of current good manufacturing practice regulations.&Applicability of current good manufacturing practice regulations.&Definitions.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 45076, Sept. 29, 1978, unless otherwise noted.§ 210.1 Status of current good manufacturing practice regulations.(a) The regulations set forth in this 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 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 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 regulations 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 provide 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 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 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&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 manufacture 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 includes 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 pretreatment 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 direct 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 product 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 preparation of the drug product.(10)&Lot&means a batch, or a specific identified portion of a batch, having uniform character and quality wit 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 quantity 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, 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 any 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 article 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 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 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 particular 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 theoretical yieldmeans 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 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 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.[43 FR 45076,&Sept. 29, 1978, as amended at 51 FR 7389,Mar. 3, 1986; 58 FR 41353,&Aug. 3, 1993]EFFECTIVE DATE NOTE: At 58 FR 41353,&Aug. 8, 1993,&was amended by adding paragraph (b)(22) effectiveAug. 3, 1994.&-&Current Good Manufacturing Practice for Finished Pharmaceuticals(21 CFR Part 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.&- Scope.&- Definitions.&- Responsibilities of quality control unit.&- Personnel qualifications.&- Personnel responsibilities.&- Consultants.&- Design and construction features.&- Lighting.&- Ventilation, air filtration, air heating and cooling.&- Plumbing.&- Sewage and refuse.&- Washing and toilet facilities.&- Sanitation.&- Maintenance.&- Equipment design, size, and location.&- Equipment construction.&- Equipment cleaning and maintenance.&- Automatic, mechanical, and electronic equipment.&- Filters.&- General requirements.&- Receipt and storage of untested components, drug product containers, and closures.&- Testing and approval or rejection of components, drug product containers, and closures.&- Use of approved components, drug product containers, and closures.&- Retesting of approved components, drug product containers, and closures.&- Rejected components, drug product containers, and closures.&- Drug product containers and closures.&&- W deviations.&- Charge-in of components.&- Calculation of yield.&- Equipment identification.&- Sampling and testing of in-process materials and drug products.&- Time limitations on production.&- Control of microbiological contamination.&- Reprocessing.&- Materials examination and usage criteria.&- Labeling issuance.&- Packaging and labeling operations.&- Tamper-evident packaging requirements for over-the-counter (OTC) human drug products.&- Drug product inspection.&- Expiration dating.&- Warehousing procedures.&- Distribution procedures.&- General requirements.&- Testing and release for distribution.&- Stability testing.&- Special testing requirements.&- Reserve samples.&- Laboratory animals.&- Penicillin contamination.&- General requirements.&- Equipment cleaning and use log.&- Component, drug product container, closure, and labeling records.&- Master production and control records.&- Batch production and control records.&- Production record review.&- Laboratory records.&- Distribution records.&- Complaint files.&- Returned drug products.&- Drug product salvaging.-General Provisions(a) The regulations in this part contain the minimum current good manufacturing practice for preparation of drug products for administration to humans or animals.(b) The current good manufacturing practice regulations in this chapter, as they pertain to drug products, and in parts 600 through 680 of this chapter, as they pertain to biological products for human use, shall be considered to supplement, not supersede, the regulations in this part unless the regulations explicitly provide otherwise. In the event it is impossible to comply with applicable regulations both in this part and in other parts of this chapter or in parts 600 through 680 of this chapter, the regulation specifically applicable to the drug product in question shall supersede the regulation in this part.(c) Pending consideration of a proposed exemption, published in the Federal Register of September 29, 1978, the requirements in this part shall not be enforced for OTC drug products if the products and all their ingredients are ordinarily marketed and consumed as human foods, and which products may also fall within the legal definition of drugs by virtue of their intended use. Therefore, until further notice, regulations under part 110 of this chapter, and where applicable, parts 113 to 129 of this chapter, shall be applied in determining whether these OTC drug products that are also foods are manufactured, processed, packed, or held under current good manufacturing practice.§&&Definitions.The definitions set forth in §&&of this chapter apply in this part.-Organization and Personnel§&&Responsibilities of quality control unit.(a) There shall be a quality control unit that shall have the responsibility and authority to approve or reject all components, drug product containers, closures, in-process materials, packaging material, labeling, and drug products, and the authority to review production records to assure that no errors have occurred or, if errors have occurred, that they have been fully investigated. The quality control unit shall be responsible for approving or rejecting drug products manufactured, processed, packed, or held under contract by another company.(b) Adequate laboratory facilities for the testing and approval (or rejection) of components, drug product containers, closures, packaging materials, in-process materials, and drug products shall be available to the quality control unit.(c) The quality control unit shall have the responsibility for approving or rejecting all procedures or specifications impacting on the identity, strength, quality, and purity of the drug product.(d) The responsibilities and procedures applicable to the quality control unit such written procedures shall be followed.§&&Personnel qualifications.(a) Each person engaged in the manufacture, processing, packing, or holding of a drug product shall have education, training, and experience, or any combination thereof, to enable that person to perform the assigned functions. Training shall be in the particular operations that the employee performs and in current good manufacturing practice (including the current good manufacturing practice regulations in this chapter and written procedures required by these regulations) as they relate to the employee's functions. Training in current good manufacturing practice shall be conducted by qualified individuals on a continuing basis and with sufficient frequency to assure that employees remain familiar with CGMP requirements applicable to them.(b)Each person responsible for supervising the manufacture, processing, packing, or holding of a drug product shall have the education, training, and experience, or any combination thereof, to perform assigned functions in such a manner as to provide assurance that the drug product has the safety, identity, strength, quality, and purity that it purports or is represented to possess.(c) There shall be an adequate number of qualified personnel to perform and supervise the manufacture, processing, packing, or holding of each drug product.§&&Personnel responsibilities.(a) Personnel engaged in the manufacture, processing, packing, or holding of a drug product shall wear clean clothing appropriate for the duties they perform. Protective apparel, such as head, face, hand, and arm coverings, shall be worn as necessary to protect drug products from contamination.(b) Personnel shall practice good sanitation and health habits.(c) Only personnel authorized by supervisory personnel shall enter those areas of the buildings and facilities designated as limited-access areas.(d) Any person shown at any time (either by medical examination or supervisory observation) to have an apparent illness or open lesions that may adversely affect the safety or quality of drug products shall be excluded from direct contact with components, drug product containers, closures, in-process materials, and drug products until the condition is corrected or determined by competent medical personnel not to jeopardize the safety or quality of drug products. All personnel shall be instructed to report to supervisory personnel any health conditions that may have an adverse effect on drug products.§&&Consultants.Consultants advising on the manufacture, processing, packing, or holding of drug products shall have sufficient education, training, and experience, or any combination thereof, to advise on the subject for which they are retained. Records shall be maintained stating the name, address, and qualifications of any consultants and the type of service they provide.-Buildings and Facilities§&&Design and construction features.(a) Any building or buildings used in the manufacture, processing, packing, or holding of a drug product shall be of suitable size, construction and location to facilitate cleaning, maintenance, and proper operations.(b) Any such building shall have adequate space for the orderly placement of equipment and materials to prevent mixups between different components, drug product containers, closures, labeling, in-process materials, or drug products, and to prevent contamination. The flow of components, drug product containers, closures, labeling, in-process materials, and drug products through the building or buildings shall be designed to prevent contamination.(c) Operations shall be performed within specifically defined areas of adequate size. There shall be separate or defined areas for the firm's operations to prevent contamination or mixups as follows:(1) Receipt, identification, storage, and withholding from use of components, drug product containers, closures, and labeling, pending the appropriate sampling, testing, or examination by the quality control unit before release for manufa(2) Holding rejected components, drug product containers, closures, and labelin(3) Storage of released components, drug product containers, closures,(4) Storage of in-(5) Manufacturing and p(6) Packaging and(7) Quarantine storage before rele(8) Storage of drug pr(9) Control and l(10) Aseptic processing, which includes as appropriate:(I) Floors, walls, and ceilings of smooth, hard surfaces that (ii) Temperature a(iii) An air supply filtered through high-efficiency particulate air filters under positive pressure, regardless of whether flow is l(iv) A system for monitoring envi(v) A system for cleaning and disinfecting the room and equipment to produc(vi) A system for maintaining any equipment used to control the aseptic conditions.(d) Operations relating to the manufacture, processing, and packing of penicillin shall be performed in facilities separate from those used for other drug products for human use.[43 FR 45077,&Sept. 29, 1978, as amended at 60 FR 4091,Jan. 20, 1995]§&&Lighting.Adequate lighting shall be provided in all areas.§&&Ventilation, air filtration, air heating and cooling.(a) Adequate ventilation shall be provided.(b) Equipment for adequate control over air pressure, micro-organisms, dust, humidity, and temperature shall be provided when appropriate for the manufacture, processing, packing, or holding of a drug product.(c) Air filtration systems, including prefilters and particulate matter air filters, shall be used when appropriate on air supplies to production areas. If air is recirculated to production areas, measures shall be taken to control recirculation of dust from production. In areas where air contamination occurs during production, there shall be adequate exhaust systems or other systems adequate to control contaminants.(d) Air-handling systems for the manufacture, processing, and packing of penicillin shall be completely separate from those for other drug products for human use.§&&Plumbing.(a) Potable water shall be supplied under continuous positive pressure in a plumbing system free of defects that could contribute contamination to any drug product. Potable water shall meet the standards prescribed in the Environmental Protection Agency's Primary Drinking Water Regulations set forth in 40 CFR part 141. Water not meeting such standards shall not be permitted in the potable water system.(b) Drains shall be of adequate size and, where connected directly to a sewer, shall be provided with an air break or other mechanical device to prevent back-siphonage.[43 FR 45077,&Sept. 29, 1978, as amended at 48 FR 11426,&Mar. 18, 1983]§&&Sewage and refuse.Sewage, trash, and other refuse in and from the building and immediate premises shall be disposed of in a safe and sanitary manner.§&&Washing and toilet facilities.Adequate washing facilities shall be provided, including hot and cold water, soap or detergent, air driers or single-service towels, and clean toilet facilities easily accessible to working areas.§&&Sanitation.(a) Any building used in the manufacture, processing, packing, or holding of a drug product shall be maintained in a clean and sanitary condition, Any such building shall be free of infestation by rodents, birds, insects, and other vermin (other than laboratory animals). Trash and organic waste matter shall be held and disposed of in a timely and sanitary manner.(b) There shall be written procedures assigning responsibility for sanitation and describing in sufficient detail the cleaning schedules, methods, equipment, and materials to be used in cleaning the buil such written procedures shall be followed.(c) There shall be written procedures for use of suitable rodenticides, insecticides, fungicides, fumigating agents, and cleaning and sanitizing agents. Such written procedures shall be designed to prevent the contamination of equipment, components, drug product containers, closures, packaging, labeling materials, or drug products and shall be followed. Rodenticides, insecticides, and fungicides shall not be used unless registered and used in accordance with the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 135).(d) Sanitation procedures shall apply to work performed by contractors or temporary employees as well as work performed by full-time employees during the ordinary course of operations.§&&Maintenance.Any building used in the manufacture, processing, packing, or holding of a drug product shall be maintained in a good state of repair.-Equipment§&&Equipment design, size, and location.Equipment used in the manufacture, processing, packing, or holding of a drug product shall be of appropriate design, adequate size, and suitably located to facilitate operations for its intended use and for its cleaning and maintenance.§&&Equipment construction.(a) Equipment shall be constructed so that surfaces that contact components, in-process materials, or drug products shall not be reactive, additive, or absorptive so as to alter the safety, identity, strength, quality, or purity of the drug product beyond the official or other established requirements.(b) Any substances required for operation, such as lubricants or coolants, shall not come into contact with components, drug product containers, closures, in-process materials, or drug products so as to alter the safety, identity, strength, quality, or purity of the drug product beyond the official or other established requirements.§&&Equipment cleaning and maintenance.(a) Equipment and utensils shall be cleaned, maintained, and sanitized at appropriate intervals to prevent malfunctions or contamination that would alter the safety, identity, strength, quality, or purity of the drug product beyond the official or other established requirements.(b) Written procedures shall be established and followed for cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing, or holding of a drug product. These procedures shall include, but are not necessarily limited to, the following:(1) Assignment of responsibility for cleaning and m(2) Maintenance and cleaning schedules, including, where appropriate, (3) A description in sufficient detail of the methods, equipment, and materials used in cleaning and maintenance operations, and the methods of disassembling and reassembling equipment as necessary to assure proper clea(4) Removal or obliteration of previous (5) Protection of clean equipment from contam(6) Inspection of equipment for cleanliness immediately before use.(7
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