苏州英语培训[Code of Federal Regulations] | [Title 21, Volume 4] | [Revid as of April 1, 2010] | [CITE: 21CFR211] | |
TITLE 21--FOOD AND DRUGS CHAPTER I--FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICES SUBCHAPTER C--DRUGS: GENERAL | PART 211 | CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS | | |
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Subpart A--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; in parts 600 through 680 of this chapter, as they pertain to drugs that are also biological products for human u; and in part 1271 of this chapter, as they are applicable to drugs that are also human cells, tissues, and cellular and tissue-bad products (HCT/Ps) and that are drugs (subject to review under an application submitted under ction 505 of the act or under a biological product licen application under ction 351 of the Public Health Service Act); supplement and do not superde the regulations in this part unless the regulations explicitly provide otherwi. In the event of a conflict between applicable regulations in this part and in other parts of this chapter, or in parts 600 through 680 of this chapter, or in part 1271 of this chapter, the regulation specifically applicable to the drug product in question shall superde the more general. (c) Pending consideration of a propod exemption, published in theFederal Registerof 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 u. 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 the OTC drug products that are also foods are manufactured, procesd, packed, or held under current good manufacturing practice. Link to an amendment published at 74 FR 65431, Dec. 10, 2009. [43 FR 45077, Sept. 29, 1978, as amended at 62 FR 66522, Dec. 19, 1997; 69 FR 29828, May 25, 2004] | |
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The definitions t forth in 210.3 of this chapter apply in this part. | |
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Subpart B--Organization and Personnel |
Sec. 211.22 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, procesd, 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 shall be in writing; such written procedures shall be followed. | |
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Sec. 211.25 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 the 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 reprented to posss. (c) There shall be an adequate number of qualified personnel to perform and supervi the manufacture, processing, packing, or holding of each drug product. | |
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Sec. 211.28 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 tho areas of the buildings and facilities designated as limited-access areas. (d) Any person shown at any time (either by medical examination or supervisory obrvation) to have an apparent illness or open lesions that may adverly 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 adver effect on drug products. | |
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Consultants advising on the manufacture, processing, packing, or holding of drug products shall have sufficient education, training, and experience, or any combination thereof, to advi 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 rvice they provide. | |
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Subpart C--Buildings and Facilities |
Sec. 211.42 Design and construction features. | |
(a) Any building or buildings ud 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 parate or defined areas or such other control systems for the firm's operations as are necessary to prevent contamination or mixups during the cour of the following procedures: (1) Receipt, identification, storage, and withholding from u of components, drug product containers, closures, and labeling, pending the appropriate sampling, testing, or examination by the quality control unit before relea for manufacturing or packaging; (2) Holding rejected components, drug product containers, closures, and labeling before disposition; (3) Storage of relead components, drug product containers, closures, and labeling; (4) Storage of in-process materials; (5) Manufacturing and processing operations; (6) Packaging and labeling operations; (7) Quarantine storage before relea of drug products; (8) Storage of drug products after relea; (9) Control and laboratory operations; (10) Aptic processing, which includes as appropriate: (i) Floors, walls, and ceilings of smooth, hard surfaces that are easily cleanable; (ii) Temperature and humidity controls; 毕业证学位证翻译(iii) An air supply filtered through high-efficiency particulate air filters under positive pressure, regardless of whether flow is laminar or nonlaminar; (iv) A system for monitoring environmental conditions; (v) A system for cleaning and disinfecting the room and equipment to produce aptic conditions; (vi) A system for maintaining any equipment ud to control the aptic conditions. (d) Operations relating to the manufacture, processing, and packing of penicillin shall be performed in facilities parate from tho ud for other drug products for human u. [43 FR 45077, Sept. 29, 1978, as amended at 60 FR 4091, Jan. 20, 1995] | |
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Adequate lighting shall be provided in all areas. | |
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Sec. 211.46 Ventilation, air filtration, air heating and cooling. | |
| blow me (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 ud 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 parate from tho for other drug products for human u. | |
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(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 t 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 wer, 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] | |
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hardwareerrorSec. 211.50 Sewage and refu. | |
Sewage, trash, and other refu in and from the building and immediate premis shall be dispod of in a safe and sanitary manner. | |
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Sec. 211.52 Washing and toilet facilities. | |
Adequate washing facilities shall be provided, including hot and cold water, soap or detergent, air driers or single-rvice towels, and clean toilet facilities easily accesible to working areas. | |
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| careertimes Sec. 211.56 Sanitation. | |
(a) Any building ud 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, incts, and other vermin (other than laboratory animals). Trash and organic waste matter shall be held and dispod 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 ud in cleaning the buildings and facilities; such written procedures shall be followed. 副部级高校(c) There shall be written procedures for u of suitable rodenticides, incticides, 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, incticides, and fungicides shall not be ud unless registered and ud in accordance with the Federal Incticide, 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 cour of operations. | |
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缨尾目Sec. 211.58 Maintenance. | |
Any building ud in the manufacture, processing, packing, or holding of a drug product shall be maintained in a good state of repair. | |
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Subpart D--Equipment |
Sec. 211.63 Equipment design, size, and location. | |
Equipment ud 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 u and for its cleaning and maintenance. | |
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