【正文】 tensils are stored and located, and cosmetic contact surfaces of equipment are covered, in a manner that protects them from splash, dust or other contamination. ? 在處理，生產(chǎn)，流轉(zhuǎn)用途的設備和器具必須有適當?shù)脑O計，原料和工藝。并通過以避免因灰塵等原因造成材料的腐蝕 ? 器具，運轉(zhuǎn)的管道和美容產(chǎn)品的生產(chǎn)設備必須間隔并整潔的放置 ? 整潔的便攜式設備和器具需被儲存，生產(chǎn)美容用品的設備需被遮蓋以避免灰塵等污染物 51 Cosmetic / Drug GMP’s ? Personnel ? The personnel supervising or performing the manufacture or control of cosmetics has the education, training and/or experience to perform the assigned functions. ? Persons ing into direct contact with cosmetic materials, finished products in bulk or cosmetic contact surfaces, to the extent necessary to prevent adulteration of cosmetic products, wear appropriate outer garments, gloves, hair restraints etc., and maintain adequate personal cleanliness. ? Consumption of food or drink, or use of tobacco is restricted to appropriately designated areas. 52 Cosmetic / Drug GMP’s ? Raw Materials ? Raw materials and primary packaging materials are stored and handled in a manner which prevents their mixup, contamination with microanisms or other chemicals, or deposition from exposure to excessive heat, cold, sunlight or moisture. ? Containers of materials are closed, and bagged or boxed materials are stored off the floor. ? Containers of materials are labeled with respect to identity, lot identification and control status. 53 Cosmetic / Drug GMP’s ? Raw Materials (continued) ? Materials are sampled and tested or examined in conformance with procedures assuring the absence of contamination with filth, microanisms or other extraneous substances to the extent necessary to prevent adulteration of finished products. Pay particular attention to materials of animal or vegetable origin and those used in the manufacture of cosmetics by cold processing methods with respect to contamination with filth or microanisms. ? Materials not meeting acceptance specifications are properly identified and controlled to prevent their use in cosmetics. 54 Cosmetic / Drug GMP’s ? Production ? The equipment for processing, transfer and filling the utensils, and the containers for holding raw and bulk materials are clean, in good repair and in sanitary condition. ? Only approved materials are used. ? Samples are taken, as appropriate, during and/or after processing, transfer or filling for testing for adequacy of mixing or other forms of processing, absence of hazardous microanisms or chemical contaminants, and pliance with any other acceptance specification. ? Weighing and measuring of raw materials is checked by a second person, and containers holding the materials are properly identified. 55 Cosmetic / Drug GMP’s ? Production (continued) ? Major equipment, transfer lines, containers and tanks are used for processing, filling or holding cosmetics are identified to indicate contents, batch designation, control status and other pertinent information. ? Labels are examined for identity before labeling operations to avoid mixup. ? The equipment for processing, holding, transferring and filling of batch is labeled regarding identity, batch identification and control status. ? Packages of finished products bear permanent code marks. ? Returned cosmetics are examined for deterioration or contamination. 56 Cosmetic / Drug GMP’s ? Laboratory ? Raw materials, inprocess samples and finished products are tested or examined to verify their identity and determine their pliance with specifications for physical and chemical properties, microbial contamination, and hazardous or other unwanted chemical contaminants. ? Reserve samples of approved lots or batches of raw materials and finished products are retained for the specified time period, are stored under conditions that protect them from contamination or deterioration, and are retested for continued pliance with established acceptance specifications. 57 Cosmetic / Drug GMP’s ? Laboratory (continued) ? The water supply, particularly the water used as a cosmetic ingredient, is tested regularly for conformance with chemicalanalytical and microbiological specifications. ? Fresh as well as retained samples of finished products are tested for adequacy of preservation against microbial contamination which may occur user reasonably foreseeable condition of storage and consumer use. 58 Cosmetic / Drug GMP’s ? Records ? Raw materials and primary packaging materials, documenting disposition of rejected materials. ? Manufacturing of batches, documenting the: ? Kinds, lots and quantities of material used. ? Processing, handling, transferring, holding and filling. ? Sampling, controlling, adjusting and reworking. ? Code marks of batches and finished products. ? Finished products, documenting sampling, individual laboratory controls, test results and control status. ? Distribution, documenting initial interstate shipment, code marks and consignees. 59 Cosmetic / Drug GMP’s ? Labeling ? On the principal display panel: ? In addition to the name of the product, the statements of identity and contents, ? On the information panel: ? The name and address of the firm manufacturing the product or introducing it into interstate merce. ? the list of ingredients (only on outer container) if intended for sale or customarily sold to consumers for consumption at home. ? Any other warning statement necessary or appropriate to prevent a health hazard. Determine the health hazard or their basis for a warning statement. ? Any direction for safe use of product. 60 Cosmetic / Drug GMP’s ? Complaints ? The kind and severity of each reported injury and the body part involved. ? The product associated with each injury, incl