【正文】 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. 167。 Consultants.Consultants advising on the manufacture, processing, packing, or holding of drug products shall have sufficient education, training, and experience, or any bination 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. Subpart CBuildings and Facilities 167。(7) Quarantine storage before release of drug products。(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] 167。 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, ponents, 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 . 135).(d) Sanitation procedures shall apply to work performed by contractors or temporary employees as well as work performed by fulltime employees during the ordinary course of operations. 167。(5) Protection of clean equipment from contamination prior to use。 Receipt and storage of untested ponents, drug product containers, and closures.(a) Upon receipt and before acceptance, each container or grouping of containers of ponents, drug product containers, and closures shall be examined visually for appropriate labeling as to contents, container damage or broken seals, and contamination.(b) Components, drug product containers, and closures shall be stored under quarantine until they have been tested or examined, as appropriate, and released. Storage within the area shall conform to the requirements of 167。 General requirements.(a) There shall be written procedures describing in sufficient detail the receipt, identification, storage, handling, sampling, testing, and approval or rejection of ponents and drug product containers and closures。(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 cleaning and maintenance。 Washing and toilet facilities.Adequate washing facilities shall be provided, including hot and cold water, soap or detergent, air driers or singleservice towels, and clean toilet facilities easily accessible to working areas. 167。(iv) A system for monitoring environmental conditions。 (5) Manufacturing and processing operations。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 bination 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.167。 Returned drug products.167。 Equipment cleaning and use log.167。 General requirements.167。 Labeling issuance.167。 Chargein of ponents. 167。 Receipt and storage of untested ponents, drug product containers, and closures. 167。 Equipment construction. 167。 Lighting. 167。 58 FR 41353, Aug. 3, 1993]EFFECTIVE DATE NOTE: At 58 FR 41353, Aug. 8, 1993, was amended by adding paragraph (b)(22) effective Aug. 3, 1994.Part 211 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 . 321, 351, 352, 355, 356, 357, 360b, 371, 374). Source: 43 FR 45077, Sept. 29, 1978, unless otherwise noted. Subpart AGeneral Provisions 167。 CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS210部分—人用及獸用藥品的生產(chǎn)、加工、包裝或貯存的CGMP（概述）211部分—制劑藥品的CGMPPart 210 CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PROCESSING, PACKING, OR HOLDING OF DRUGS。 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 ply 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 ply with those regulations applicable to the operations in which he or she is engaged.167。 Responsibilities of quality con