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INTRODUCTION 前言
This guidance describes FDA's current thinking on defining, establishing, and documenting manufacturing activitiesof the parties involved in contract drug manufacturing subject to current good manufacturing practice (CGMP) requirements. In particular, we describe how parties involved in contract drug manufacturing can use quality agreements to delineate their manufacturing activities to ensure compliance with CGMP.
本指南講述了FDA當(dāng)前對(duì)于受到CGMP約束的藥品委托生產(chǎn)所涉及各方如何定義、設(shè)立和記錄生產(chǎn)活動(dòng)的看法，尤其是藥品委托各方如何使用質(zhì)量協(xié)議來(lái)描繪其生產(chǎn)活動(dòng)，以確保符合CGMP。
For purposes of this guidance, we use certain terms with the following specific meanings:
在本指南中，我們使用了特定的術(shù)語(yǔ)，其在指南中的含義如下：
Current Good Manufacturing Practice (CGMP) refers to requirements in the Federal Food, Drug, and Cosmetic Act (FD&C Act), section 501(a)(2)(B), for all drugs and active pharmaceutical ingredients (APIs). For finished human and animal drugs, the term includes applicable requirements under 21 CFR parts 210 and 211. For biologics, the term includes additional applicable requirements under 21 CFRparts 600-680.
CGMP：指FD&C法案第501（a）(2)(B)中對(duì)所有制劑和原料藥的要求。對(duì)于人用和獸用制劑，該術(shù)語(yǔ)包括21CFR第210和211部分中適用的要求。對(duì)于生物制品，術(shù)語(yǔ)還包括21CFR第600-680部分中適用的額外要求。
Commercial manufacturing refers to manufacturing processes that result in a drug or drugs intended to be marketed, distributed, or sold.
商業(yè)化生產(chǎn)：指準(zhǔn)備用于上市銷售的藥品的生產(chǎn)過(guò)程。
Commercial manufacturing does not include research and development activities, manufacturing of material for investigational new drug studies (e.g., clinical trials, expanded access), or manufacturing of material for veterinary investigational drugs. Although this guidance does not explicitly apply to the manufacture of investigational, developmental, or clinical trial materials, FDA believes that quality agreements can be extremely valuablein delineating the activities of all parties involved in contract research and development arrangements. Many of the principles described in this guidance could be applied in pre-commercial stages of the pharmaceutical life cycle.
商業(yè)化生產(chǎn)并不包括研發(fā)活動(dòng)、臨床新藥研究用原料的生產(chǎn)（例如，臨床試驗(yàn)、擴(kuò)大使用面），以及獸用臨床藥所用原料的生產(chǎn)。雖然本指南并未明確指出適用于臨床前、研發(fā)、和臨床研究用原料，但FDA相信質(zhì)量協(xié)議在描繪委托研發(fā)安排中所有各方活動(dòng)時(shí)會(huì)極有價(jià)值。本指南中所述的許多原則可以使用于藥品生命周期中商業(yè)化之前的階段。
Manufacturing includes processing, packing, holding, labeling operations, testing, and quality unit operations.
生產(chǎn)：包括加工、包裝、保存、貼標(biāo)操作、檢測(cè)和質(zhì)量部門操作。
A manufactureris anentity that engages in CGMP activities, including implementation of oversight and controls over the manufacture of drugs to ensure quality[2].
生產(chǎn)商：指從事CGMP活動(dòng)，包括實(shí)施藥品生產(chǎn)監(jiān)管和控制以確保質(zhì)量的實(shí)體。
Quality unit is defined as synonymous with the term quality control unit[3].
質(zhì)量部門：與質(zhì)量控制部門是同義詞。
This guidance covers commercial manufacturing of the following categoriesof drugs: human drugs, veterinary drugs, certain combination products, biological and biotechnology products, finished products, APIs, drug substances, in-process materials, and drug constituents of combination drug/device products[4]. This guidance does not cover the following types of products: Type A medicated articles and medicated feed, medical devices, dietary supplements, or human cells, tissues, or cellular or tissue-based products regulated solely under section 361 of the Public Health Service Actand 21 CFR part 1271.
本指南覆蓋以下類型的藥品商業(yè)生產(chǎn)：人用藥、獸用藥、部分藥械組合產(chǎn)品、生物制品和生物技術(shù)藥品、制劑、原料藥、藥用物質(zhì)、在制物料以及藥械組合產(chǎn)品中的藥物成分。本指南不覆蓋以下類型的產(chǎn)品：A類藥用材料和藥用飼料、醫(yī)療器械、膳食補(bǔ)充劑以及僅受到公共衛(wèi)生服務(wù)法案第361部分和21CFR第1271部分管理人體細(xì)胞、組織和細(xì)胞/組織衍生產(chǎn)品。
In general, FDA's guidance documents do not establish legally enforceable responsibilities. Instead, guidances describe the Agency's current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required.
一般來(lái)說(shuō)，F(xiàn)DA的指南文件并沒(méi)有法定強(qiáng)制力。相反，指南描述的只是當(dāng)局目前對(duì)某個(gè)議題的看法，除其中所引用的法律法規(guī)要求外，其它內(nèi)容應(yīng)該只是作為建議來(lái)看待。SHOULD一詞在當(dāng)局指南中只是表示建議或推薦某事，并不是強(qiáng)制要求。
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