FDA行业指南中英对照待完成

1、FDA行业指南中英对照待完成Guidance for IndustryContainer Closure Systems for Packaging Human Drugs and BiologiesChemistry, Manufacturing and Controls Documentation行业指南人用药品及生物制品的包装容器和封装系统：化学，生产和控制文件指南发布者：美国FDA下属的CDER及CBER发布日期：May 1999TABLE OF CONTENTS 目录I. II.INTRODUCTION 介绍 BACKGROUND 背景 A. B. C.III.Definitions

2、 定义CGMP, CPSC and USP Requirements on Containers and Closures. CGMP, CPSC 和 USP对容器和密封的要求Additional Considerations其他需要考虑的事项QUALIFICATION AND QUALITY CONTROL OF PACKAGING COMPONENTS 包装组件的合格要 求以及质量控制A. B. C. D. E. F. G. H.IV. V.Introduction 介绍General Considerations 通常要求Information That Should Be Submit

3、ted in Support of an Original Application for Any Drug Product为支持任何药品的原始申请所必须提供的信息Inhalation Drug Products吸入性药品Drug Products for Injection and Ophthalmic Drug Products 注射剂和眼科用药 Liquid-Based Oral and Topical Drug Products and Topical Delivery Systems 液体 口服和外用药品和外用给药系统Solid Oral Dosage Forms and Powde

4、rs for Reconstitution 口服固体剂型和待重 新溶解的粉末Other Dosage Forms 其他剂型POSTAPPROVAL PACKAGING CHANGES 批准后的包装变更 TYPE III DRUG MASTER FILES 药品主文件第III类A. B.VI.A. B.General Comments 总体评述Information in a Type III DMF 第 III 类 DMF 中包括的信息 Containers for Bulk Drug Substances 用于原料药的容器 Containers for Bulk Drug Products

5、用于散装药 品的容器BULK CONTAINERS大包装容器ATTACHMENT A 附件 AREGULATORY REQUIREMENTS 药政要求ATTACHMENT B 附件 BCOMPLIANCE POLICY GUIDES THAT CONCERN PACKAGING 关于包装，所适用的政策指南ATTACHMENT C 附件 CEXTRACTION STUDIES 提取性”研究 ATTACHMENT D 附件 DABBREVIATIONS 缩略语ATTACHMENT E 附件 EREFERENCES参考文献GUIDANCE FOR INDUSTRY1Container Closure

6、 Systems for Packaging Human Drugs and BiologiesChemistry, Manufacturing and Controls DocumentationThis guidance document represents the Agency, s current thinking on container closure systems for the packaging of human drugs and biological products. It does not create or confer any rights for or on

7、 any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statute, regulations, or both.本指南代表了 FDA目前对于人用药品和生物制品包装的容器/封装 系统方面的看法。本指南不具强制力。与本指南不相同的替代措施也可采用，前提是能满 足相应法律/法规的要求。I. INTRODUCTION介绍This docume

8、nt is intended to provide guidance on general principles for submitting information on packaging materials used for human drugs and biologies. This guidance supersedes the FDA Guideline for Submitting Documentation for Packaging for Human Drugs and Biologies , issued in February 1987 and the packagi

9、ng policy statement issued in a letter to industry dated June 30, 1995 from the Office of Generic Drugs. This guidance is not intended to describe the information that should be provided about packaging operations associated with drug product manufacture.本文件目的是为递交人用药品和生物制品 的包装信息提供总体原则指南。本文件替代了 FDA在1

10、987年2月发布的另一份指南，以 及替代了仿制药办公室在1995年6月30日向行业内发布的包装政策声明信。本指南不描 述药品的包装操作。Approaches which differ from those described in this guidance may be followed, but the applicant is encouraged to discuss significant variations in advance with the appropriate CDER chemistry review staff or CBER review staff. This

11、is to prevent applicants or sponsors from spending unnecessary time and effort in preparing a submission that the FDA may later432determine to be unacceptable.可以采取与本指南的内容不一致的措施，但是我 们建议申请人就明显的差异预先与CDER或CBER的审核人员进行讨论。这样做的目的是为 了避免申请人或发起人花费不必要的时间和努力准备申报资料，而这种申报资料经FDA认 定是不可接受的。II. BACKGROUND背景The Federal

12、 Food, Drug, and Cosmetic Act (the Act) mandates the need for adequate information related to packaging materials. Section 501(a)(3) of the Act states that a drug is deemed to be adulterated deleterious substance which may render the contents injurious to health. . . . 502 of the Act states that a d

13、rug is considered misbranded if there are packaging omissions. Also, section 505 of the Act requires a full description of the methods used in, and the facilities and controls used for, the packaging of drugs (see Attachment A).联邦食品、药品和化妆品法案(简称“法案”)要求必须提供包装材料的充分信息。法案的第501(a) (3)部分规定，如果某个药品的包装材料含有有毒、

14、有害的物质，导致药 品损坏健康，那么该药品为劣药。另外，法案的第502部分规定，如果某药品在包装方面 有缺失，则被认为是贴错标签。还有，法案第305部分要求详细描述包装药品时所用的方 法，所用的设施和控制措施(见附件A)。Section 505(b) (1) (D) of the Act states that an application shall include a full description of the methods used in, the manufacturing, processing and packing of such drug. This includes f

15、acilities and controls used in the packaging a drug product.法案的第505 (b) (1) (D)部分规定，申请人必须完整描述该药 品的生产、加工和包装。其中包括包装药品时的设施和控制措施。A.Definitions 定义Materials of construction refer to the substances (eg,glass, high density polyethylene (HDPE) resin, metal) used to manufacture a packaging component.组成材料是指用来生

16、产包装组件的物质(例如玻璃，HDPE树脂，金属)A packaging component means any single part of a container closure system. Typical components are containers (e.g. , ampules, vials, bottles), container liners (e.g. , tube liners), closures (e.g. , screw caps, stoppers), closure liners, stopper overseals, container inner sea

17、ls, administration ports (e.g., on large-volume parenterals (LVPs), overwraps, administration accessories, and container labels. A primary packaging component means a packaging component that is or may be in direct contact with the dosage form. A secondary packaging component means a packaging compo

18、nent that is not and will not be in direct contact with the dosage form.包装组件是指一个容器/封装系统的 任何单独部分。通常的组件有容器(例如安甑，西林瓶，瓶子)，容器垫，封装，封装 垫.等，包括给药附件和容器标签。一级包装组件是指与制剂直接接触的组件，或者 可能会直接接触的组件。二级包装组件是指不会与制剂直接接触的组件。A container closure system refers to the sum of packaging components that together contain and protect

19、 the dosage form. This includes primary packaging components and secondary packaging components, if the latter are intended to provide additional protection to the drug product. A packaging system is equivalent to a container closure65system.容器/封装系统是指包装组件的组合，在一起盛装和保护制剂。这包括一 级包装组件和二级包装组件，后者的目的是为药品提供额

20、外保护。包装系统就等同于容器 /封装系统。A package or market package refers to the container closure system and labeling, associated components (e.g., dosing cups, droppers, spoons), and external packaging (e.g., cartons or shrink wrap). A market package is the article provided to a pharmacist or retail customer upon p

21、urchase and does not include packaging used solely for the purpose of shipping such articles. 包装 或上市包装是指容器/封装系统，以及标签，相关组件(例如量杯，滴管，药匙等)，以 及外包装(例如纸箱或收缩包装)。上市包装是指提供给药剂师或零售消费者的包装物件, 不包括仅仅用于运输目的的包装物件。Quality refers to the physical, chemical, microbiological, biological, bioavailability, and stability att

22、ributes that a drug product should maintain if it is to be deemed suitable for therapeutic or diagnostic use. In this guidance, the term is also understood to convey the properties of safety, identity, strength, quality, and purity (see 21 CFR 211.94(a).7质量是指：一种药品可被看做具有治疗或诊断用途时，它所具有的理化、微生物、生 物、生物利用度

23、以及稳定性方面的品质。在本指南中，此术语还被理解为安全性，等效性, 规格，质量和纯度等性质(见21 CFR 211.94(a) «An extraction profile refers to the analysis (usually by chromatographic means) of extracts obtained from a packaging component. A quantitative extraction profile is one in which the amount of each detected substance is determined

24、,提取性特征是指对从包装组件中所得提取物的分析(通常用色谱的方法)。 定量提取性特征是指所提取的每种成分的测得量。B.CGMP, CPSC and USP Requirements on Containers and Closures CGMP, CPSC 和 USP对容器和密封的要求Current good manufacturing practice (CGMP) requirements for the control of drug product containers and closures are included in 21 CFR Parts 210 and 211. A l

25、isting of the relevant sections is provided in Attachment A. In addition, a listing of Compliance Policy Guides that deal with packaging issues is provided in Attachment B. References in this guidance to CGMP regulations are provided for completeness. For additional information, refer to the FDA Com

26、pliance Program Guidance Manual for Pre-Approval Inspections/Investigations (7346.832) which describes specific responsibilities for CDER scientists and for field investigators.现行良好生产规范(CGMP)关于“药品容器/封装的控制”的 要求在21 CFR的第210和211部分。相关部分的清单请见附件A。另外，关于包装方面的 "Compliance Policy Guides达标政策指南”清单请见附件B。本指南

27、关于CGMP的参考文献对本指南有补充作用。更多的信息，请参考“FDA达标项目指南手册”，以指导“批 准前检查/调查(7346.832) ”，里面描述了 CDER科学家和现场检查的具体职责。The FDA requirement for tamper-resistant closures is included in 21 CFR 211.132 and the Consumer Product Safety Commission (CPSC) requirements for child-resistantclosures are included in 16 CFR 1700. An out

28、line of these and other applicable regulatory requirements is provided in Attachment A. FDA 关尸防篡改 封装的要求请见21 CFR 211. 132,消费者产品安全委员会(CPSC)对“儿童防护封装”的 要求请见16 CFR 1700o附件A提供了这些法规要求和其他相应法规要求的要点。The United States Pharmacopeial Convention has established requirements for containers which are described in m

29、any of the drug product monographs in The United States Pharmacopeiaz/Nationa1 Formulary (USP/NF). For capsules and tablets, these requirements generally relate to the design characteristics of the container (e.g., tight, well-closed or light-resistant). For injectable products, materials of constru

30、ction are also addressed (e.g., Type I glass, protected from lightNotices and Requirementsthe USP. The requirements for materials of construction are defined in the 'Chapters'美国药典委员会建立了对 容器的要求，这在“美国药典/国家处方集(USP/NF) ”的各药品专论中进行了描述。对 于胶囊和片剂，这些要求通常与容器的设计特征有关(例如牢固，密闭良好，或者避光)。 对于注射剂产品，还有生产材料的要求(例如，”保存在单次给药或多次给药容器中，最 好采用I型玻璃，避光”)。这些要求在美国药典的“通则和要求”(保存，包装，贮存 和标签)部分。关于生产材料的要求在美国药典的“总章”(请见附件A) . C.Additional Considerations其他需要考虑的事项LSubmissions of INDsThe packaging information in the chemistry, manufacturing, and controls section of an IND usually includes a bri