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 翻譯：julia朱玉姣   來源：蒲公英

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Contract Manufacturing Arrangements for Drugs: Quality Agreements

Guidance for Industry[1]

行業(yè)指南：藥品委托生產(chǎn)安排：質(zhì)量協(xié)議

This guidance represents  the current thinking of the Food and Drug Administration (FDA or Agency)  on this topic. It does not establish  any rights for any person and is not binding on FDA  or the public. You can use  an alternative approach  if it satisfies  the requirements of the applicable statutes and regulations. To discuss  an alternative approach, contact the FDA office responsible for this guidance as listed on the title  page.

  本指南代表FDA當(dāng)前對(duì)此問題的看法。它并未賦予任何人以任何權(quán)力，也不對(duì)FDA和公眾具有任何強(qiáng)制約束。如果你有一個(gè)替代的方法滿足適用的法律法規(guī)要求，你可以使用該方法。如需對(duì)替代方法進(jìn)行討論，請(qǐng)聯(lián)系本指南標(biāo)題頁(yè)上的FDA官方負(fù)責(zé)人。

I.        INTRODUCTION 前言

This guidance describes FDA’s currentthinking on defining, establishing, anddocumenting manufacturing activitiesof the parties involved in contractdrug manufacturing subjectto current good manufacturing practice (CGMP)requirements.  Inparticular, we describe how parties involved in contract drug manufacturingcan use quality agreements to delineate their manufacturing activities to ensurecompliance 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)議來描繪其生產(chǎn)活動(dòng)，以確保符合CGMP。

For purposes of this guidance,we use certain terms withthe 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 ManufacturingPractice (CGMP) refers to requirements in the Federal Food, Drug, andCosmetic Act (FD&C Act),section 501(a)(2)(B), for all drugs and activepharmaceutical ingredients (APIs).  Forfinished human and animal drugs,the term includes applicable requirements under 21 CFR parts 210 and 211. Forbiologics, the term includesadditional 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 drugsintended 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)過程。

·        Commercial manufacturing does not include research and development activities, manufacturing of materialfor investigational new drug studies(e.g., clinical trials, expandedaccess), or manufacturing of material for veterinary investigational drugs. Although this guidance does not explicitly apply tothe manufacture of investigational, developmental, or clinical trial materials, FDA believes that quality agreements can be extremely valuablein delineating the activities of all parties involvedin contract research and developmentarrangements.  Many of theprinciples described in this guidancecould be applied in pre-commercial stagesof 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 ofoversight and controlsover 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。

·        Qualityunit is defined as synonymous with the term qualitycontrol unit[3].

·        質(zhì)量部門：與質(zhì)量控制部門是同義詞。

This guidance covers commercial manufacturingof the following categoriesof drugs:  human drugs,veterinary drugs, certain combination products, biological and biotechnology products, finishedproducts, APIs, drug substances, in-process materials, and drug constituentsof combinationdrug/device products[4].   This guidancedoes not cover thefollowing typesof products:  Type A medicated articles and medicatedfeed, medical devices, dietarysupplements, orhuman cells, tissues, or cellular or tissue-based productsregulated solely undersection 361 of the PublicHealth 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 guidancedocuments do not establish legally enforceable responsibilities. Instead, guidancesdescribe the Agency’s currentthinking on a topic and should be viewed only asrecommendations, unless specificregulatory or statutoryrequirements are cited.The use of the word should in Agency guidances means that somethingis suggested orrecommended, but not required.

一般來說，F(xiàn)DA的指南文件并沒有法定強(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。

[1] This guidancehas been preparedby the Office of Pharmaceutical Qualityand the Officeof Compliance in the Centerfor Drug Evaluation and Research in cooperation with the Center for Biologics Evaluation and Research,the Center for Veterinary Medicine, and the Office of Regulatory Affairs at the Food and Drug Administration.

[2] See section 501 of the FD&C Act, as amended by the Food and Drug Administration Safety and Innovation Act (PublicLaw 112-144, title VII, section711).

參見FD&C法案第501部分及FDA安全和創(chuàng)新法案修正（公共法112-114，標(biāo)題VII，711部分）

[3] For quality controlunit, see 21 CFR 210.3.

質(zhì)量控制部門參見21CFR21.3.

[4] Combination product manufacturers can apply this guidance to their quality agreements because they are subjectto requirements under 21 CFR part 211 and/or21 CFR part 820 (see 21 CFR 4.3).In addition to facilitating compliance with requirements under 21 CFR part 211, manufacturers can use qualityagreements with contract facilities to demonstrate compliance, in part, with 21 CFR 820.50 (purchasing controls) andwith 21 CFR 820.80(b) (receiving acceptance activities) for combination products.

藥械組合產(chǎn)品生產(chǎn)商可以在其質(zhì)量協(xié)議中適用此指南，因?yàn)樗麄円艿?1CFR第211和/或21CFR第820部分（參見21CFR4.3）要求的約束。除了有助于符合21CFR第211部分的要求外，生產(chǎn)商還可以與受托方使用質(zhì)量協(xié)議來說明其符合組合產(chǎn)品的21CFR820.50（采購(gòu)控制）和21CFR820.80（b）（接受可接受活動(dòng)）要求。

FDA行業(yè)指南 委托生產(chǎn)質(zhì)量協(xié)議 中英文.pdf

17027_Quality Agreements.pdf