【正文】 tity 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 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. 58 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. 59 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。 ) 66 Medical Device cGMPs Subpart B – Quality System Requirements 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。 ) 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。 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。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。 ? 裝置物，電線以及管道等必須被合理安裝，以避免有房屋滲漏現(xiàn)象導(dǎo)致機械表面，籮筐里面的成品的破損。 What is a Complaint?什么是投訴 31 ? Requirements are discussed in 21CFR 要求在 21CFR ? The regulation requires 規(guī)章要求 ? Documented procedures 進程文檔記錄 ? Timely and uniform processing 及時一致的處理 ? Process for evaluation/investigation 評估方法 ? Adverse event consideration (serious injury or death)不利方面的考慮（嚴(yán)重的損傷或死亡） ? Additional requirements apply to plaints alleging serious injury or death (21 CFR 803) 正對嚴(yán)重損傷或死亡的申訴的額外要求（ 21CFR803) What About Complaint Files? 投訴文件 32 ? A pilation of records containing the production history of a finished device. 記錄需包含每個成品的生產(chǎn)歷史 ? A DHR includes DHR包含 ? Dates of manufacture 生產(chǎn)日期 ? Quantity manufactured and released 數(shù)量和生產(chǎn) ? Acceptance records 可接受記錄 ? Primary identification label 主要確認(rèn)標(biāo)記 ? Device identification and lot number 產(chǎn)品確認(rèn)和生產(chǎn)標(biāo)號 What is a DHR?DHR是什么？ 33 ? Maintained at the manufacturing site or otherwise reasonable ? Legible and plete (errors must be appropriately corrected) 易讀的和完成的（錯誤必須適當(dāng)糾正） ? Retained for the life of the product (minimum 2 years from date of release).產(chǎn)品壽命需維持從生產(chǎn)日期起至少 2年） ? Exceptions include Management Review, Quality Audits and Supplier ，質(zhì)量審核和供應(yīng)商審核 Record Requirements 記錄要求 34