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文件準備 DHF+DMR+DHR (圖紙/裝配圖，測試規範(DHF)—(轉移給生產)->裝配指導書WI、測試者島書WI(DMR)—(生產過程…

- - - - The DMR for each type of device shall include, or refer to the location of, the following information
        
        Device specifications(產品規格等文件)
        
        Drawings(圖紙)
        
        Composition(成分)
        
        Formulation(公式)
        
        Component specification(組成的規範)
        
        Software specifications(軟體的規範)
        
        外購件採購清單
        
        Equipment specification(設備規範)
        
        Production process specification(生產工作指導書)
        
        Production methods(生產方法)
        
        Production procedures(生產程序)
        
        Production environment specification(生產環境)
        
        Quality assurance procedures and specifications (檢驗作業指導書+QC工程表)
        
        Acceptance criteria(接受的標準)
        
        Quality assurance equipment(使用的設備)
        
        Packaging and labeling specification(包裝方式與標籤說明書)
        
        Methods and processes used (使用方法和過程)
        
        Installation, maintenance, and servicing procedures and methods(安裝+維護+服務程序+方法)
- - - - QSR&820.30(c)設計輸入-FDA
        
        該需求並指定之人審查及核准，製造商應紀錄核准結果
        
        核准日
        
        核准人員簽名
        
        Validation protocols and data for finished devices
    - - 製造商應建立並維持程序將器材設計正確地轉換成生產規格
      - QSR820中有設計轉移，轉移的結果就是DMR
    - - 當器材規格、方法、製程變更時，製造商應依照既定程序評估變更是否需提出上市前通知
    - - Show plans were followed
      - Show specifications were met
- - - - The DHR shall include, or refer to the location of, the following information
    - - Rework and reevaluation activities, including a determination of any adverse effect from the rework upon the product, shall be documented in the DHR
    - - Correct expiration date(有效期限)
      - Control number(管制號碼)
      - Storage instructions(保存說明)
      - Handling instructions(操作說明)
      - 其他處理程序說明
      - 需求
        
        應於DHR中記錄標籤檢查程序
        
        檢查日期
        
        檢查人員簽名
        
        The label and labeling used for each production unit, lot, or batch shall be documented in the DHR
    - - 產品批紀錄這些表格要來自於DMR檔中