20xx年醫學專題—美國藥典及其食品補充劑(成分)認證(編輯修改稿)

　

【文章內容簡介】 t Systems 文件管理體系 Adequate Equipment/Facilities 滿足要求的設備/設施 Sample/Component Control Program 樣品/物料的控制程序 Deviation Policy/Logs 偏差方針/記錄 Appropriate Laboratory Controls 合適的實驗室控制 Label Control Revision Process 標簽修訂的控制過程 ShelfLife Evaluation Program 貨架期評估 Quality Assurance Review/Release 質量保證復核/放行程序(ch233。ngx249。) Process Performance Evaluation 工藝運行評估 Electronic Records/Computerized Systems Compliance 電子化記錄/計算機系統的符合性,第二十一頁，共四十五頁。,Product Documentation 文件(w233。nji224。n)審核,Manufacturing processes documentation 生產過程文件 Master Formula 主配方 Environmental controls 環境控制 QC check points 質量控制檢查點 Equipment, reprocessing criteria 設備, 再加工標準 Cleaning procedures 清潔程序 Quality control documentation, (continued) 質量控制文件 Raw material and inprocess material specifications 原材料和中間(zhōngjiān)物料標準 Packaging and labeling material including specifications and samples 包裝和標簽的采樣和質量標準 Final product specifications conform to USP–NF when applicable, or per acceptable manufacturer criteria 成品符合USPNF或可接受的生產廠商標準,第二十二頁，共四十五頁。,Product Documentation, Continued 文件(w233。nji224。n)審核,Quality Control Documentation 質量控制文件(w233。nji224。n) Method verification (USP General Chapter validation of compendial methods) 方法驗證 USP Reference materials (USP RS or acceptable characterization to support suitability of use) 標準品(USP RS 或可以接受的標準品) Stability 穩定性 Long term (label storage conditions through end of declared shelflife) 長期(直至宣稱的貨架期為止的儲存條件) Accelerated (1 lot, 3 months at 40176。C/75%RH) 加速(1批, 3個月, 40176。C/75%RH) Number of products lots evaluated chosen by product categories = √n + 1 基于產品類別的評估批數選擇 √n + 1 Where n = of products in category 產品類別 Minimum of 3 lots 至少三批,第二十三頁，共四十五頁。,Laboratory Testing of Product Samples 樣品(y224。ngpǐn)的實驗室測試,Identity 鑒別 Potency/label declaration 效價/標簽說明 Performance characteristics 特性 Contaminants—not to exceed acceptable levels 污染物—不超過可接受水平 Heavy metals 重金屬 Pesticides (botanicals) 農藥(n243。ngy224。o)殘留(植物類) PCBs, Dioxins, and Furans (fish oil) 聚氯聯苯, 二惡英, 呋喃(魚油) Microbial contaminants: Total plate count。 yeast aflatoxins (Botanicals) 微生物污染: 總菌落數, 酵母amp。霉菌, 致病菌(大腸桿菌, 沙門氏菌, 金黃色葡萄球菌), 黃曲霉素(植物類) Other quality standards (Friability, hardness as appropriate) 其它質量指標(如適用, 脆碎度, 硬度等),第二十四頁，共四十五頁。,Review of Mark Usage 標識使用(shǐy242。ng)審核,Manufacturers must submit for USP’s approval, all artwork for product labels and promotional materials carrying the mark. 生產廠家(chǎnɡ jiā)必須提交帶有該標識的產品標簽和促銷材料原件, 并由USP批準.,USP will review mark use for USP會審核標識 Appropriate proportions and look 適當的比例和外觀 Descriptive statement appearing with mark 有關標識的陳述語 Clarity and good taste 清晰美觀(měiguān) Proper representation of verification 對USP認證的恰當體現,第二十五頁，共四十五頁。,Approval Process 批準(pī zhǔn)程序,Status of issues or deficiencies 偏差或事件狀態 Action Level 1 – issues involve major changes to the current quality system 1級行動水平 – 包含對目前質量體系的主要變更 Action Level 2 – issues involve lack of information regarding quality system program element 2級行動水平 – 缺少質量體系元素相關的信息 Action Level 3 – issues involve need for clarifying information