【正文】 發(fā)展的保證。? Stage 1 – Process Design: The mercial manufacturing process is defined during this stagebased on knowledge gained through development and scaleup activities.? 第一階段工藝設(shè)計: 在開發(fā)和放大活動過程中獲得的知識基礎(chǔ)上，在此階段對商品化制造工藝進行定義。工藝驗證涉及整個產(chǎn)品生命周期和生產(chǎn)中發(fā)生的一系列活動。? 生產(chǎn)工藝的每一步均予以控制，確保成品符合包括規(guī)格在內(nèi)所有質(zhì)量屬性。8 See “Pharmaceutical cGMPS for the 21st Century — A RiskBased Approach: Second Progress Report and ImplementationPlan,” available atscGMPforDrugs/.8 參見《21 世紀制藥業(yè)現(xiàn)行藥品生產(chǎn)規(guī)范一種基于風(fēng)險的方法：第二份進展報告實施計劃》，可從以下網(wǎng)址獲得：scGMPforDrugs/。7 The 1987 guidance was prepared by a working group that included representation from the Center for Devices andRadiological Health (CDRH). Since that time, CDRH elected to reference a process validation guidance prepared incooperation with the Global Harmonization Task Force (GHTF). The principles and remendations in that document, QualityManagement Systems – Process Validation, edition 2 (available on the Internet at ) are alsouseful to consider for drug manufacturing processes.7 從那時以來， CDRH 選擇與全球協(xié)調(diào)工作組（the Global Harmonization Task Force (GHTF)）合作編制的工藝驗證指南作為參考。質(zhì)量保證的基本原則在于生產(chǎn)出來的藥品符合其預(yù)定用途。用于驗證制藥的cGMP 法規(guī)要求藥品在高度保證符合所有預(yù)期擁有屬性的情況下生產(chǎn)(《聯(lián)邦法規(guī) 21 編 （a）和（a）》)。8 該修訂版指南取代1987 年版指南。該修訂版指南傳達了FDA 目前對工藝驗證的看法，并與1987 年版指南首次提出的基本原則相一致。6 See the FDA guidance for industry, Validation of Procedures for Processing of Human Tissues Intended for Transplantation,available on the Internet at6．參見FDA 行業(yè)指南《擬用作移植的人體組織工藝流程驗證》，可從以下網(wǎng)址獲得：包含不具約束力的建議中文譯稿：北京大學(xué)藥物信息與工程研究中心 info4CGMPs for the 21st Century ― A RiskBased Approach,” particularly with regard to the use of technologicaladvances in pharmaceutical manufacturing, as well as implementation of modern risk management andquality system tools and This revised guidance replaces the 1987 guidance.1987 年5 月11 日，F(xiàn)DA 在聯(lián)邦公告 (52 FR 17638)上發(fā)布公告，宣布題為《工藝驗證一般原則指導(dǎo)原則》的指南（1987 年版指南）面世。II. BACKGROUND二. 背景In the Federal Register of May 11, 1987 (52 FR 17638), FDA issued a notice announcing the availability of aguidance entitled Guideline on General Principles of Process Validation (the 1987 guidance).7 Since then, wehave obtained additional experience through our regulatory oversight that allows us to update ourremendations to industry on this topic. This revised guidance conveys FDA’s current thinking on processvalidation and is consistent with basic principles first introduced in the 1987 guidance. The revised guidancealso provides remendations that reflect some of the goals of FDA’s initiative entitled “Pharmaceutical5 Guidance on process validation for medical devices is provided in a separate document, Quality Management Systems –Process Validation, edition 2, available at ，《質(zhì)量管理體系工藝驗證》，第二版，可在。相反，除非引述具體的監(jiān)管或法規(guī)要求，指南描述的是本機構(gòu)目前對該主題的看法，應(yīng)該僅僅被視為建議。然而，該指南與包括工藝過程自動設(shè)備在內(nèi)的工藝驗證有關(guān)。有興趣的人士可以參考相應(yīng)指南或聯(lián)系相應(yīng)中心以確定應(yīng)包括在提交文件中的信息類型。ICH Q7 第十二部分詳細描述了活性藥物成分工藝驗證的原則。4截止本指南發(fā)布之日，單獨針對藥物組分如有效藥用成分(藥用物質(zhì))和中間體的現(xiàn)行藥品生產(chǎn)質(zhì)量管理規(guī)范尚未公布，但這些組分受《聯(lián)邦食品、藥品和化妝品法》第501節(jié)(a)(2)(B) 法定cGMP要求約束。This guidance covers the following categories of drugs:? Human drugs? Veterinary drugs? Biological and biotechnology products? Finished products and active pharmaceutical ingredients (APIs or drug substances)4? The drug constituent of a bination (drug and medical device) product本指南涵蓋下列類別的藥物：? 人用藥? 獸用藥? 生物和生物技術(shù)制品? 制劑產(chǎn)品和活性藥物成分（原料藥或藥用物質(zhì)）4? 組合產(chǎn)品（藥物和醫(yī)療器械）的藥物組分This guidance does not cover the following types of products:? Type A medicated articles and medicated feed? Medical devices5? Dietary supplements? Human tissues intended for transplantation regulated under section 361 of the Public Health Service2To make sure you have the most recent version of a guidance, check the CDER guidance page at, the CBER guidance page at,or the CVM guidance page at，請核對藥物評價與研究中心（CDER）網(wǎng)頁，網(wǎng)址為：,生物制品評價與研究中心（CBER）指南網(wǎng)頁，網(wǎng)址為：,或獸藥中心指南網(wǎng)頁，網(wǎng)址為：3 In this guidance, the term mercial manufacturing process refers to the manufacturing process resulting in mercialproduct (., drug that is marketed, distributed, and sold or intended to be sold). For the purposes of this guidance, the termmercial manufacturing process does not include clinical trial or treatment IND material.，商品化生產(chǎn)工藝這一專業(yè)名詞指生產(chǎn)出商品化產(chǎn)品的生產(chǎn)工藝（即用于經(jīng)銷、流通、出售或擬出售的藥品）。The lifecycle concept links product and process development, qualification of the mercial manufacturingprocess,3 and maintenance of the process in a state of control during routine mercial production. Thisguidance supports process improvement and innovation through sound science.生命周期概念銜接產(chǎn)品和工藝開發(fā)、商品化生產(chǎn)工藝確認以及日常商品化制造中處于受控狀態(tài)的過程維護。包含不具約束力的建議中文譯稿：北京大學(xué)藥物信息與工程研究中心 info2品注冊技術(shù)規(guī)范國際協(xié)調(diào)會議(ICH)行業(yè)指南，Q8(R2)《藥品開發(fā)》、Q9《質(zhì)量風(fēng)險管理》和Q10《藥品質(zhì)量體系》。該指南收編了所有生產(chǎn)商可用于驗證生產(chǎn)工藝的多種原則和方法。如果您不能確定相應(yīng)的FDA 工作人員，請撥打本指南標題頁所列的相應(yīng)電話號碼。如果替代方法能夠滿足適用法律、法規(guī)的要求，您可以使用替代方法。 傳真：3018478714druginfo和/或馬里蘭州洛克維爾市洛克維爾大道1401號 HFM40 FDA生物制品評價和研究中心對外信息、外聯(lián)與發(fā)展辦公室 郵政編碼：208521448電話：8008354709 或 3018271800和/或馬里蘭州洛克維爾市Standish Place 7519號食品藥品管理局獸藥中心HFV12通訊處，郵政編碼：20885電話：2402769300. Department of Health and Human ServicesFood and Drug AdministrationCenter for Drug Evaluation and Research (CDER)Center for Biologics Evaluation and Research (CBER)Center for Veterinary Medicine (CVM)January 2011Current Good Manufacturing Practices (CGMP)Revision 1美國衛(wèi)生與人類服務(wù)部食品藥品管理局藥物評估和研究中心（CDER）生物制品評估和研究中心（CBER）獸藥中心（CVM）2011年1月現(xiàn)行藥品質(zhì)量生產(chǎn)管理規(guī)范（CGMP）修訂版 1包含不具約束力的建議中文譯稿：北京大學(xué)藥物信息與工程研究中心 infoTable of Contents目錄I. INTRODUCTION ........................................................................................................................................ 1一. 簡介 .......................................................................................................................................................... 1II. BACKGROUND ......................................................................................................................................... 3二. 背景 ...........................................