Container Closure Systems for Packaging

Subpart A-General Provisions§ Scopea)The regulations in this part contain theminimum current good manufacturing practice for preparation of drug products for administration to humans or animals.b)The current good manufacturing practiceregulations in this chapter, as they pertain to drug products, and in parts 600 through 680 of this chapter, as they pertain to biological products for human use, shall be considered to supplement, not supersede, the regulations in this part unless the regulations explicitly provide otherwise. In the event it is impossible to comply with applicable regulations both in this part and in other parts of this chapter or in parts 600 through 680 of this chapter, the regulation specifically applicable to the drug product in question shall supersede the regulation in this part.c)Pending consideration of a proposedexemption, published in the Federal Register of September 29, 1978, theA．总则211．1 范围（a）本部分的条例包含人用或兽用药品制备的现行最低限度的药品生产管理规范（GMP）。

发布日期20110531栏目化药药物评价>>化药质量控制标题FDA人用药品和生物制品包装用容器密封系统指导原则（一）作者高杨部门化药药学二部正文内容按语：美国FDA于1999年5月发布了人用药品和生物制品包装用容器密封系统指导原则（Container Closure Systems for Packaging Human Drugs and Biologics），继而于3年后再次发布了人用药品和生物制品包装用容器密封系统指导原则--问与答（Container Closure Systems for Packaging Human Drugs and Biologics--Questions and Answers），该指导原则代表了FDA关于人用药品和生物制品包装用容器密封系统的现行观点，对于我国药品注册申请者和药品监管当局都具有很高的借鉴意义。

EMEA 直接接触塑料包装材料指导原则的中文版已经于2011年4月在药审中心网站上以电子刊物发表。

此次将FDA的相关指导原则翻译成中文，供业界参考研究。

本文在翻译过程中得到了百特（中国）投资有限公司的金天明女士和龚明涛博士的大力支持，在此表示诚挚谢意。

尽管译稿经过笔者认真校核，但是由于水平有限，文中错误再所难免，恳请批评指正。

限于电子刊物的篇幅，将该指导原则将分为四篇连续刊出，前三篇为人用药品和生物制品包装用容器密封系统指导原则，最后一篇为人用药品和生物制品包装用容器密封系统指导原则--问与答，本文为第一篇。

指导原则人用药品和生物制品包装用容器密封系统化学，生产和质控文件美国卫生及公共服务部食品与药品管理局药品评价与研究中心(CDER)生物制品评价和研究中心(CBER)1999年5月指导原则人用药品和生物制品包装用容器密封系统化学，生产和质控文件另外的副本可以从以下地点得到：培训和交流办公室交流管理处药品信息科，HFD-210药品评价与研究中心(CDER)5600 Fishers LaneRockville, Maryland 20857（电话）301-827-4573（网址）/cder/guidance/index.htm或交流，培训和生产商支持办公室，HFM-40生物制品评价和研究中心(CBER)1401 Rockville PikeRockville, Maryland 20852-1448（传真）888-CBERFAX或301-827-3844（语音信息）800-835-4709或301-827-1800（网址）/cber/guidelines.htm美国卫生及公共服务部食品与药品管理局药品评价与研究中心(CDER)生物制品评价和研究中心(CBER)1999年5月目录I．引言II．背景A．定义B．CGMP、CPSC和USP对包装容器的要求C．其他需要考虑的因素III．包装组件的合格性确认和质量控制A．引言B．一般要求C．为支持任何药品的原始申请而应提供交的资料D．吸入制剂E．注射剂和眼用制剂F．口服液体制剂、局部用制剂及其局部用给药系统G．口服固体制剂和复溶用粉末H．其他剂型Ⅳ．批准后的包装变更Ⅴ．Ⅲ类DMF文件A．总体说明B．Ⅲ类DMF中包括的信息Ⅵ．大包装容器A．散装原料药用容器B．散装制剂用容器附件A法规要求附件B与包装有关的政策指南附件C提取物研究附件D缩略语附件E参考文献行业指南1人用药品和生物制品包装用容器封闭系统指导原则化学，生产和质控文件I．引言本指导原则为提交人用药品与生物制品2所用包装材料信息提供一般原则的指导3。

Subpart A-General Provisions§ Scopea)The regulations in this part contain theminimum current good manufacturing practice for preparation of drug products for administration to humans or animals.b)The current good manufacturing practiceregulations in this chapter, as they pertain to drug products, and in parts 600 through 680 of this chapter, as they pertain to biological products for human use, shall be considered to supplement, not supersede, the regulations in this part unless the regulations explicitly provide otherwise. In the event it is impossible to comply with applicable regulations both in this part and in other parts of this chapter or in parts 600 through 680 of this chapter, the regulation specifically applicable to the drug product in question shall supersede the regulation in this part.c)Pending consideration of a proposedexemption, published in the Federal Register of September 29, 1978, theA．总则211．1 范围（a）本部分的条例包含人用或兽用药品制备的现行最低限度的药品生产管理规范（GMP）。

发布日期20110531栏目化药药物评价>>化药质量控制标题FDA人用药品和生物制品包装用容器密封系统指导原则（四）作者高杨部门化药药学二部正文内容化药药学二部主译：高杨按语：美国FDA于1999年5月发布了人用药品和生物制品包装用容器密封系统指导原则（Container Closure Systems for Packaging Human Drugsand Biologics），继而于3 年后再次发布了人用药品和生物制品包装用容器密封系统指导原则--问与答（Container Closure Systems for PackagingHuman Drugs and Biologics--Questions and Answers），该指导原则代表了FDA关于人用药品和生物制品包装用容器密封系统的现行观点，对于我国药品注册申请者和药品监管当局都具有很高的借鉴意义。

EMEA直接接触塑料包装材料指导原则的中文版已经于2011年4月在药审中心网站上以电子刊物发表。

此次将FDA的相关指导原则翻译成中文，供业界参考研究。

本文在翻译过程中得到了百特（中国）投资有限公司的金天明女士和龚明涛博士的大力支持，在此表示诚挚谢意。

尽管译稿经过笔者认真校核，但是由于水平有限，文中错误再所难免，恳请批评指正。

限于电子刊物的篇幅，将该指导原则将分为四篇连续刊出，前三篇为人用药品和生物制品包装用容器密封系统指导原则，最后一篇为人用药品和生物制品包装用容器密封系统指导原则--问与答，本文为第四篇。

指导原则人用药品和生物制品包装用容器密封系统问与答美国卫生及公共服务部食品与药品管理局药品评价与研究中心(CDER)生物制品评价和研究中心(CBER)2002年5月CMC指导原则人用药品和生物制品包装用容器密封系统问与答另外的副本可以从以下地点得到：培训和交流办公室药品信息处，HFD-240药品评价与研究中心食品与药品管理局5600 Fishers LaneRockville, MD 20857（电话）301-827-4573/cder/guidance/index.htm或交流，培训和生产商协助办公室，HFM-40生物制品评价和研究中心食品与药品管理局1401 Rockville Pike, Rockville, MD 20852-1448 /cber/guidelines.htm传真：1-888-CBERFAX 或301-827-3844电话：语音信息系统800-835-4709 或301-827-1800 美国卫生及公共服务部食品与药品管理局药品评价与研究中心(CDER)生物制品评价和研究中心(CBER)2002年5月CMC指导原则1人用药品和生物制品包装用容器密封系统问与答本指导原则代表食品药品监督管理局对于该主题的当前意见。

您现在的位置：电子刊物>> 电子刊物列表>> 电子刊物详细发布日期20110531栏目化药药物评价>>化药质量控制标题FDA人用药品和生物制品包装用容器密封系统指导原则（二）作者高杨部门化药药学二部正文内容按语：美国FDA于1999年5月发布了人用药品和生物制品包装用容器密封系统指导原则（Container Closure Systems for Packaging Human Drugs and Biologics），继而于3 年后再次发布了人用药品和生物制品包装用容器密封系统指导原则--问与答（Container Closure Systems for Packaging Human Drugsand Biologics--Questions and Answers），该指导原则代表了FDA关于人用药品和生物制品包装用容器密封系统的现行观点，对于我国药品注册申请者和药品监管当局都具有很高的借鉴意义。

EMEA 直接接触塑料包装材料指导原则的中文版已经于2011年4月在药审中心网站上以电子刊物发表。

此次将FDA的相关指导原则翻译成中文，供业界参考研究。

本文在翻译过程中得到了百特（中国）投资有限公司的金天明女士和龚明涛博士的大力支持，在此表示诚挚谢意。

尽管译稿经过笔者认真校核，但是由于水平有限，文中错误再所难免，恳请批评指正。

限于电子刊物的篇幅，将该指导原则将分为四篇连续刊出，前三篇为人用药品和生物制品包装用容器密封系统指导原则，最后一篇为人用药品和生物制品包装用容器密封系统指导原则--问与答，本文为第二篇。

C．为支持任何药品的初次申请而应提交的资料15申请资料（NDA、ANDA或BLA）CMC部分中应当提供的其他资料相关的信息和讨论请见附录E列出的指导原则。

1．说明申报资料的CMC 部分应当提供整个容器密封系统的总体说明。

此外，申请人还应提供包装系统每个组件的以下信息：a．产品名称、产品代码（如果有的话）、生产厂名称及地址、包装组件物理特征（例如型号、大小、形状和颜色）。

201308 FDA指南：ANDA：原料药和制剂稳定性试验问答（中英文）Guidance for Industry 行业指南ANDAs: Stability Testing of Drug Substances and ProductsQuestions and AnswersANDA：原料药和制剂稳定性试验问答DRAFT GUIDANCE指南草案This guidance document is being distributed for comment purposes only.本指南文件发布仅供讨论。

Comments and suggestions regarding this draft document should be submitted within 60 days of publication in the Federal Register of the notice announcing the availability of the draft guidance. Submit electronic commentsto . Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number listed in the notice of availability that publishes in the Federal Register. For questions regarding this draft document contact (CDER) Radhika Rajagopalan 240-276-8546.U.S. Department of Health and Human ServicesFood and Drug AdministrationCenter for Drug Evaluation and Research (CDER)August 2013GenericsGuidance for IndustryANDAs: Stability Testing of Drug Substances and ProductsQuestions and AnswersANDA：原料药和制剂稳定性试验问答Additional copies are available from:Office of CommunicationsDivision of Drug Information, WO51, Room 2201Center for Drug Evaluation and ResearchFood and Drug Administration10903 New Hampshire Ave., Silver Spring, MD 20993Phone: 301-796-3400; Fax: 301-847-8714druginfo@/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm U.S. Department of Health and Human ServicesFood and Drug AdministrationCenter for Drug Evaluation and Research (CDER)August 2013Generics Contains Nonbinding Recommendations Draft — Not for ImplementationTABLE OF CONTENTSI. INTRODUCTION 介绍II. QUESTIONS AND ANSWERS 问与答A. General 一般问题B. Drug Master File 药物主文件.C. Drug Product Manufacturing and Packaging 药品生产和包装D. Amendments to Pending ANDA Application 未批准ANDA申请的增补E. Stability Studies 稳定性试验.Guidance for Industry[1]ANDAs: Stability Testing of Drug Substances andProductsQuestions and AnswersANDA：原料药和制剂稳定性试验问答This draft guidance, when finalized, will represent the Food and Drug Administration’s (FDA’s) current thinking on this topic. It does not create or confer any right s for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. If you want to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance. If you cannot identify the appropriate FDA staff, call the appropriate number listed on the title page of this guidance.本指南草案，如果最终定稿，代表的是FDA目前对这一专题的态度。

Container Closure Systems for Packaging Human Drugsand BiologicsQuestions and AnswersU.S. Department of Health and Human ServicesFood and Drug AdministrationCenter for Drug Evaluation and Research (CDER)Center for Biologics Evaluation and Research (CBER)May 2002CMCContainer Closure Systems for Packaging Human Drugsand BiologicsQuestions and AnswersAdditional copies are available from:Office of Training and CommunicationsDivision of Drug Information, HFD-240Center for Drug Evaluation and ResearchFood and Drug Administration5600 Fishers LaneRockville, MD 20857(Tel) 301-827-4573/cder/guidance/index.htmorOffice of Communication, Training andManufacturers Assistance, HFM-40Center for Biologics Evaluation and ResearchFood and Drug Administration1401 Rockville Pike, Rockville, MD 20852-1448/cber/guidelines.htmFax: 1-888-CBERFAX or 301-827-3844Phone: the Voice Information System at 800-835-4709 or 301-827-1800U.S. Department of Health and Human ServicesFood and Drug AdministrationCenter for Drug Evaluation and Research (CDER)Center for Biologics Evaluation and Research (CBER)May 2002CMCGuidance for Industry1Container Closure Systems for PackagingHuman Drugs and BiologicsQuestions and AnswersThis document provides questions and answers relating to the guidance on Container Closure Systems for Packaging Human Drugs and Biologics (the guidance).2 The questions are based on those posed to CDER by applicants.Q1:Table 5 of the guidance (section III.E.2) provides information on the American Academy of Ophthalmology (AAO) uniform color coding system for the caps and labels of topical ocular medications. Is there a source for current information on this coding system?A1:Current information on the AAO color coding system can be found on AAO’s Web site at http:/// (type color coding in the search entry box).Q2:Section VI.B of the guidance states that container closure systems for on-site storage have generally been considered a Current Good Manufacturing Practices (CGMP)issue. However, the guidance goes on to state that if a firm plans to hold bulk drugproducts3 in storage, then the container closure system and the maximum storage time should be described and justified in the application. If this is a CGMP issue, doesinformation need to be included in the application?1 This guidance has been prepared by the Packaging Technical Committee of the Chemistry, Manufacturing, and Controls Committee (CMCCC) in the Center for Drug Evaluation and Research (CDER) at the Food and Drug Administration (FDA).2 A notice of availability for this guidance published in the Federal Register on July 7, 1999 (64 FR 36694).3 A bulk drug product means finished dosage form that has not yet been packaged into the container closure systems intended for market and/or sale.A2:Information on container closure systems used for storage of bulk drug products, other than biologics or protein drug products, need not be included in the application.However, these container closure systems should be shown to be suitable for theirintended use. The suitability of the storage containers should be supported by dataretained by the applicant and/or manufacturer and should be made available duringFDA inspection upon demand. Information as requested in section VI.B. of thepackaging guidance should be included in the application on the container closuresystem for storage prior to packaging or shipping of biologics and protein drugproducts, including container closure suitability. This information should be providedfor biologics and proteins because, in general, there is greater potential for adverseeffects on the identity, strength, quality, purity, or potency of biologics and proteindrug products during storage or shipping.Q3:Section VI.B of the guidance states that a container closure system for the transportation of bulk drug products to contract packagers should be described in the application; section VI.B also provides recommendations on information to include in the application. However, different recommendations are provided for holding bulkdrug products in storage, and this situation appears to include shipping of bulk drugproducts between applicant-owned manufacturing sites and applicant-ownedpackaging sites. Why are the recommendations different for these similar situations?A3: Information on container closure systems used for shipping (i.e., between applicant's own facilities or contract facilities) and bulk drug products, other than biologics orproteins, need not be included in the application. However, these container closuresystems should be shown to be suitable for their intended use. The suitability of thestorage containers should be supported by data retained by the applicant and/ormanufacturer and should be made available during FDA inspection upon demand.Information as requested in section VI.B. of the packaging guidance on the containerclosure system for storage (shipping) of biologics and protein drug products,including container closure suitability, should be included in the application. Thisinformation should be provided for biologics and proteins because, in general, there isgreater potential for adverse effects on the identity, strength, quality, purity, orpotency of biologics and proteins during storage or shipping.。

专利名称：Container closure system发明人：Jöbstl, Elisabeth,Wegner, Gerald,Solberg-Eriksen, Asbjørn,Delaporte, Eric申请号：EP15152521.9申请日：20150126公开号：EP3047833A1公开日：20160727专利内容由知识产权出版社提供专利附图：摘要：The invention relates to a container closure system containing an overpouch with an intransparent first foil (10) and a transparent second foil (20), a transparentprimary container (2) for holding a transparent pharmaceutical solution (3), wherein thetransparent primary container (2) is packed within the overpouch (1) and labeled with at least one label (4) and wherein the at least one label (4) acts as a light absorbing segment having a reflection R for light in the range of 350 nm to 800 nm and an inner surface (18) of the intransparent first foil (10) of the overpouch (1) acts as a light reflecting background having a reflection R for light in the direction of the primary container (2) in the range of 350 nm to 800 nm with R > R. By the transparent second foil (20) and the inventive reflection properties it is achieved that the at least one label (4) on the primary container (2) is visible and readable. Additionally, visual inspection of the content of the transparent primary container (2) is possible. A good contrast is achieved to enhance machine and human readability.申请人：Fresenius Kabi Deutschland GmbH地址：Else-Kröner-Strasse 1 61352 Bad Homburg DE国籍：DE代理机构：Fresenius Kabi Deutschland GmbH更多信息请下载全文后查看。

专利名称：CONTAINER AND CLOSURE发明人：TSAKAS, Spyridon Edouard,TSAKAS, Spyridon Christos申请号：GB2015/052597申请日：20150908公开号：WO2016/038357A1公开日：20160317专利内容由知识产权出版社提供专利附图：摘要：A closure for dispensing one or more active agents into a container comprises a sealed or sealable chamber having a breakable wall and a hollow piston slidably mounted in a piston guide. Said hollow piston comprises an outer wall having an end inthe chamber and at least one ventilation aperture. Said end has a cutting formation. Said hollow piston is slidable in the piston guide between a ventilation position in which the at least one ventilation aperture allows ventilation of the chamber and a sealed position in which the at least one ventilation aperture is sealed to prevent ventilation of the chamber and a deployed position in which the cutting formation has broken through at least a portion of the breakable wall. The outer wall has a retaining formation which engages with the piston guide to releasably resist sliding of the hollow piston between the ventilation position and the sealed position and the deployed position. The hollow piston may have an outer wall, and said outer wall has an end within the chamber, facing the breakable wall, wherein the cutting end has a first edge having a cutting formation and a gap in said cutting formation.申请人：EULYSIS UK LIMITED地址：EH25 9PP GB国籍：GB代理人：HINDLE, Alistair Andrew更多信息请下载全文后查看。