【正文】 ) 73 Medical Device cGMPs Subpart F – Identification Traceability 167。 Purchasing Controls Procedures for ensuring received product services conform to specified requirements. Evaluations (suppliers, contractors, consultants) Establish and maintain requirements ? Evaluate select on basis of meeting requirements, document evaluation ? Define control based on evaluation results ? Establish maintain records of acceptable suppliers 72 Medical Device cGMPs Subpart E – Purchasing Controls 167。 Personnel General Sufficient personnel with necessary education, training, background and experience Training Training procedures Personnel are adequately trained Documented 70 Medical Device cGMPs Subpart D – Document Controls 167。 Management Responsibility (continued) 68 Medical Device cGMPs Subpart B – Quality System Requirements Quality audit procedures shall be in place to assure: Quality system is in pliance Determination of effectiveness of system Quality audits Auditor shall be independent Corrective Actions taken Audit reports Audits reaudits results dates are documented 167。 ) 66 Medical Device cGMPs Subpart B – Quality System Requirements 167。s primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes.“ 65 Medical Device cGMPs Subpart A – General Provisions 167。并通過(guò)以避免因灰塵等原因造成材料的腐蝕 ? 器具，運(yùn)轉(zhuǎn)的管道和美容產(chǎn)品的生產(chǎn)設(shè)備必須間隔并整潔的放置 ? 整潔的便攜式設(shè)備和器具需被儲(chǔ)存，生產(chǎn)美容用品的設(shè)備需被遮蓋以避免灰塵等污染物 50 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. 51 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. 52 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. 53 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. 54 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. 55 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. 56 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. 57 Cosmetic / Drug GMP’s ? Records ? Raw materials and prima