【正文】 e 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, including the manufacturer and code number. ? The medical treatment involved, if any, including the name of the attending physician. ? The name(s) and location(s) of any poison control center, government agency, physician39。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.“ 66 Medical Device cGMPs Subpart A – General Provisions 167。 ) 67 Medical Device cGMPs Subpart B – Quality System Requirements 167。 Authority Resources Management Representative 68 Medical Device cGMPs Subpart B – Quality System Requirements Management Review Management with Executive responsibility reviews the suitability and effectiveness of the quality system at defined intervals. Quality Planning Quality Plan Quality Practices Resources Activities Established how the plan will be met Quality System Procedures Procedures Outline of Structure 167。 reaudits results amp。 Quality Audit 70 Medical Device cGMPs Subpart B – Quality System Requirements 167。 Document Controls Procedure shall be established and maintained to control all documents required by the cGMPs Document approval and distribution Designated individual(s) Available at use Controlled Document changes Reviewed and approved Communicated Change records – description, identification of affected documents, signatures, approval date, amp。 Purchasing Controls Procedures for ensuring received product amp。 consultants) Establish and maintain requirements ? Evaluate amp。 maintain records of acceptable suppliers 73 Medical Device cGMPs Subpart E – Purchasing Controls