【正文】 USP飲食補(bǔ)充劑成分認(rèn)證(r232。)的GMP檢查,Audit for compliance with 審核依據(jù) ICH Q7 Guideline Good Manufacturing Practices for Active Pharmaceutical Ingredients (Audit Criteria) ICH Q7 原料藥良好(li225。,USP Dietary Ingredient Verification (IVP) 美國(guó)藥典食品補(bǔ)充劑原料(yu225。,Approval Process 批準(zhǔn)(pī zhǔn)程序,Status of issues or deficiencies 偏差或事件狀態(tài) Action Level 1 – issues involve major changes to the current quality system 1級(jí)行動(dòng)水平 – 包含對(duì)目前質(zhì)量體系的主要變更 Action Level 2 – issues involve lack of information regarding quality system program element 2級(jí)行動(dòng)水平 – 缺少質(zhì)量體系元素相關(guān)的信息 Action Level 3 – issues involve need for clarifying information 3級(jí)行動(dòng)水平 – 需要澄清說明相關(guān)的信息 Formal letter notifies participant of approval of product to carry mark 正式書面通知參與者認(rèn)證產(chǎn)品被批準(zhǔn)(pī zhǔn)使用USP標(biāo)識(shí),第二十六頁，共四十五頁。,Laboratory Testing of Product Samples 樣品(y224。n)審核,Manufacturing processes documentation 生產(chǎn)過程文件 Master Formula 主配方 Environmental controls 環(huán)境控制 QC check points 質(zhì)量控制檢查點(diǎn) Equipment, reprocessing criteria 設(shè)備, 再加工標(biāo)準(zhǔn) Cleaning procedures 清潔程序 Quality control documentation, (continued) 質(zhì)量控制文件 Raw material and inprocess material specifications 原材料和中間(zhōngjiān)物料標(biāo)準(zhǔn) Packaging and labeling material including specifications and samples 包裝和標(biāo)簽的采樣和質(zhì)量標(biāo)準(zhǔn) 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(chǎn)廠商標(biāo)準(zhǔn),第二十二頁，共四十五頁。,GMP Audit of Manufacturing Sites 生產(chǎn)(shēngchǎn)場(chǎng)地的GMP檢查,Audit for compliance with 審核依據(jù) The USP General Chapter, “Manufacturing Practices for Dietary Supplements” 美國(guó)藥典 “食品補(bǔ)充劑生產(chǎn)管理規(guī)范(guīf224。d242。nzhǎo)食品補(bǔ)充劑上的USP認(rèn)證標(biāo)志,Your assurance 您可以(kěyǐ)獲得以下保證 What’s on the label is in the bottle 內(nèi)容物和標(biāo)簽”表里如一” The supplement does not contain 補(bǔ)充劑不含有達(dá)到危害水平的污染物 harmful levels of contaminants. The supplement will break 補(bǔ)充劑完全溶解有利于體內(nèi)吸收 down properly to allow ingredients to dissolve in your body. The supplement has 生產(chǎn)工藝安全,衛(wèi)生 been made under safe, sanitary, manufacturing processes.,第十五頁，共四十五頁。 翻譯：為便于美國(guó)藥典在中文使用者中的應(yīng)用，雙方同意開展將美國(guó)藥典翻譯成中文的工作；另外(l236。,第十二頁，共四十五頁。ng) 為USP原料認(rèn)證計(jì)劃提供支持 第三方實(shí)驗(yàn)室檢測(cè)服務(wù) (例如USPNPA檢測(cè)項(xiàng)目),第九頁，共四十五頁。,USP Convention Headquarters,第六頁，共四十五頁。,USP’s Verification Programs 美國(guó)藥典認(rèn)證(r232。)的組織,Independent and unbiased. 獨(dú)立公正 Established in 1820. 188 years of experience in setting standards: prescription and OTC medicines, dietary supplements, and other healthcare products. 成立于1820年, 具有188年建立涉及處方藥品,非處方藥品, 食品(sh237。nl236。,第三頁，共四十五頁。ng)流程,第五頁，共四十五頁。ch233。,China and USP: Partnering Opportunities Memoranda of Understanding官方(guānfāng)合作：諒解備忘錄,2008年3月3日至5日,國(guó)家食品藥品監(jiān)督管理局吳湞副局長(zhǎng)應(yīng)邀率團(tuán)訪問美國(guó)藥典委員會(huì),簽署(qiānshǔ)中美藥典合作備忘錄。 代理美國(guó)藥典在中國(guó)的銷售發(fā)行。,Look for the USPVerified Mark on Your Dietary Supplements 尋找(xodiǎn)食品補(bǔ)充劑 產(chǎn)品認(rèn)證,Pharmacopoeia Forum ( PF) 收載 (但不僅限于) Grape Seeds Oligomeric Proanthocyanidins 葡萄籽低聚原花青素 Powdered Soy Isoflavones Extract 大豆(d224。)/召回 Electronic Data Control 電子化數(shù)據(jù)控制 Supplier Verification 供應(yīng)商確認(rèn),第十九頁，共四十五頁。nji224。C/75%RH) Number of products lots evaluated chosen by product categories = √n + 1 基于產(chǎn)品類別的評(píng)估批數(shù)選擇 √n + 1 Where n = of products in category 產(chǎn)品類別 Minimum of 3 lots 至少三批,第二十三頁，共四十五頁。ng)審核,Manufacture