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标题: 【2016第一周总结】CFDA最新动态 [打印本页]
作者: aiyao 时间: 2016-1-7 09:27 PM
标题: 【2016第一周总结】CFDA最新动态
本帖最后由 aiyao 于 2016-1-7 11:30 PM 编辑
按照国家食品药品监督管理总局工作部署，以下品种被列为 2016 年度进口药品境外生产现场检查任务。国家食品药品监督管理总局食品药品审核查验中心负责相关检查组织实施。现场检查不仅限于下列品种 , 如有增补，另行公告。 序号
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| | | Schaper & Brvmmer GmbH & Co.KG ； | |
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| 中长链脂肪乳 / 氨基酸 (16)/ 葡萄糖(30%) 注射液 | | | |
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| | | Novartis Europharm Limited | |
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| | | Astellas Pharma Europe B.V. | |
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| | | Allergan Pharmaceuticals Ireland | |
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| | | Bristol-Myers Squibb Company | |
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| | | GlaxoSmithKline Australia Pty Ltd | |
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| | | Strakan International Limited | |
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| | | GlaxoSmithKline Biologicals S.A. | |
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| | | Merck Sharp & Dohme Limited | |
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| | | Xellia Pharmaceuticals ApS | |
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| | | Fresenius Kabi Deutschland GmbH | |
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| 橄榄油脂肪乳 (15%)/氨基酸 (17)/ 葡萄糖(18.75%) 注射液 | | | |
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| | JXHZ1200163 JXHZ1300101 JXHZ1300333 JXHZ1400305 JXHZ1500166 | | |
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| | | Roche Pharma (Schweiz) Ltd. | |
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| | | Merck Sharp & Dohme Corp. | |
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| | | Trb Phrma Ind Quimica E Farmaceutica Ltda. | |
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| | | Vellpharm Company Limited Vietnam | 越南 VELLPHARM 药品责任有限公司广州代表处 |
| 42
| | | Vellpharm Company Limited Vietnam | 越南 VELLPHARM 药品责任有限公司广州代表处 |
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| | | Roche Pharma （ Schweiz ）Ltd. | |
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| | | Kremers Urban Pharmaceuticals Inc. | |
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| | | NAPP PHARMACEUTICALS LIMITED | |
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| | | Takeda Pharmaceuticals Limited Liability company | |
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特此公告。
国家食品药品监督管理总局食品药品审核查验中心 2016 年 1 月 6 日
附件1： 检查相关要求告知书 附件2： 品种基本情况表 附件3： SMF清单
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附件一： 进口药品境外生产现场检查
相关要求告知书
各有关单位:
按照国家食品药品监督管理总局工作部署，你单位品种被列入2016年度进口药品境外生产现场检查任务。现将境外检查部分相关要求告知如下:
一、境外检查有关要求
1.各代理机构明确两个固定联系人，包括联系人信息：手机、座机、传真、邮箱等，以保证检查准备工作沟通顺畅。
2．请填写《进口药品境外生产现场检查基本情况表》，并于通气会召开之日起15个工作日内，并将电子文件发送至我中心联系邮箱，纸质文件2套加盖公章寄送至中心。请注意其中要求提出可以接受现场检查的时间。现场检查期间要求企业安排检查品种动态生产。
3.请于会议召开2个月内向中心提交SMF中英文版纸质文件各2套，电子文件发送邮件或刻录光盘交我中心。纸质SMF文件应予打印并加盖公章寄送中心。
二、联系方式
国家食品药品监督管理总局食品药品审核查验中心 检查二处
联系人：王元 010-87559066
周艳 010-87559063
传 真：010-87559064/54
地 址：北京市东城区法华南里11号楼3层
邮 编：100061
附件二：进口药品境外生产现场检查基本情况
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剂 型
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目前注册进度
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生产地址
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工厂X**
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生产地址
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代理机构
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地 址
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联系人A
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电子邮件
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联系人B
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电子邮件
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建议检查时间1
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建议检查时间X
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近5年进口情况***
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历次申请情况***
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| 1. 品种生产工艺流程及相关工艺生产周期、对应生产地点 2. 进口药品注册证（如适用） |
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| 产品近期有无发生变更或计划变更情况 □ 无 □ 有 _____________________________________________________ |
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公 章
年 月 日
填表说明：
*工厂包括：产品生产、包装、检验、放行等涉及生产行为的所有工厂
**标注X处可根据实际情况增加表格字段
***如内容较多可另附文件说明
附件三：Contentof Site Master File
现场主文件清单
企业总体情况
企业联系信息
- Nameand official address of the manufacturer;
企业名称、注册地址；
- Namesand street addresses of the site, buildings and production units located on thesite;
企业生产工厂以及工厂内建筑及生产车间名称和地址；
- Contactinformation of the manufacturer including 24 hrs telephone number of thecontact personnel in the case of product defects or recalls;
企业联系方式（包括出现产品缺陷或召回事件时24小时联系人电话）;
- Identificationnumber of the site as e.g. GPS details, D-U-N-S (Data Universal NumberingSystem) Number (a unique identification number provided by Dun& Bradstreet)of the site or any other geographic location system.
现场识别号码，例如GPS详细情况，D-U-N-S号码（数据通用编号系统）（一个由Dun& Bradstreet提供的独特识别号码）或者任何其他地理定位系统。
药品生产许可范围
- Copyof the valid manufacturing authorization issued by the relevant CompetentAuthority in Appendix 1; or when applicable, reference to the EudraGMPdatabase. If the Competent Authority does not issue manufacturing authorizations,this should be stated;
附件1中提供相关监管机构签发的有效生产许可文本复印件，必要时，可参考EudraGMP数据库。如遇监管机构不签发生产许可情况，应予以说明。
- Briefdescription of manufacture, import, export, distribution and other activitiesas authorised by the relevant Competent Authorities including foreignauthorities with authorized dosage forms/activities, respectively; where notcovered by the manufacturing authorization;
简要描述由相关监管机构许可的生产、进口、出口、分销和其他活动，包括许可文件中没有提及的国外机构许可的剂型/生产活动等;
- Typeof products currently manufactured on-site (list in Appendix 2) where notcovered by Appendix 1 or the EudraGMP database;
在附件2中列出附录1或EudraGMP数据库中没有提及的工厂目前生产的产品类型;
- Listof GMP inspections of the site within the last 5 years; including dates andname/country of the Competent Authorities having performed the inspection. Acopy of current GMP certificate (Appendix 3) or reference to the EudraGMPdatabase should be included, if available.
近5年工厂接受GMP检查情况，包括检查时间和实施检查的监管机构名称及国家。如果有，请在附件3中提供当前的GMP证书的复印件或参考EudraGMP数据库。
工厂目前进行的其它生产活动
- Descriptionof non-pharmaceutical activities on-site, if any.
如工厂有非药品生产活动，请说明。
生产企业质量管理体系
生产企业质量管理体系
- Briefdescription of the quality management systems run by the company and referenceto the standards used;
简要描述公司质量管理体系运行情况以及参考的标准；
- Responsibilitiesrelated to the maintaining of quality system including senior management;
包括高级管理层在内的质量体系相关职责，。
- Informationof activities for which the site is accredited and certified, including datesand contents of accreditations, names of accrediting bodies.
工厂质量体系获得认证认可的情况，包括认证认可日期、认可内容、认可机构名称等。
成品放行程序
- Detaileddescription of qualification requirements (education and work experience) ofthe Authorised Person(s)/ Qualified Person(s) responsible for batchcertification and releasing procedures;
详细描述负责批确认与放行程序的授权人的资质要求;
- Generaldescription of batch certification and releasing procedure;
概述批确认与放行程序；
- Roleof Authorised Person/ Qualified Person in quarantine and release of finishedproducts and in assessment of compliance with the Marketing Authorisation;
授权人/产品放行人在待验与放行以及上市许可一致性评估中的职责；
- Thearrangements between Authorised Persons/ Qualified Persons when severalAuthorised Persons/ Qualified Persons are involved;
当涉及多名授权人时的工作安排；
- Statementon whether the control strategy employes Process Analytical Technology (PAT)and/or Real Time Release or Parametric Release.
请说明是否应用过程分析技术（PAT）及实时或参数放行产品。
供应商和合同商的管理
- Abrief summary of the establishment/knowledge of supply chain and the externalaudit program;
简述公司供应链以及外部审计项目等情况；
- Briefdescription of the qualification system of contractors, manufacturers of activepharmaceutical ingredients (API) and other critical materials suppliers;
简述合同商、原料药生产企业及其他关键物料供应商的资质确认系统；
- Measurestaken to ensure that products manufactured are compliant with TSE(Transmittinganimal spongiform encephalopathy)guidelines.
采取哪些措施确保生产品种符合TSE （动物传染脑海绵状病）指南要求。
- Measuresadopted where counterfeit/falsified products, bulk products(i.e.unpackedtablets), active pharmaceutical ingredients or excipients are suspected oridentified.
对假药以及原辅料等造假风险较高的地区，采取哪些措施予以控制。
- Use ofoutside scientific, analytical or other technical assistance in relation tomanufacture and analysis;
委托生产和委托检验及其它项目委托情况
- Listof contract manufacturers and laboratories including the addresses and contactinformation and flow charts of supply-chains for outsourced manufacturing andQuality Control activities; e.g. sterilization of primary packaging materialfor aseptic processes, testing of starting raw materials etc, should bepresented in Appendix 4;
合同生产企业和实验室名单，包括以下信息：地址、联系方式、委托生产和质量检验活动的供应链流程图；例如：无菌工艺产品所用内包装材料灭菌、起始物料的检验等均应在附录4中予以表述清楚；
- Briefoverview of the responsibility sharing between the contract giver and acceptorwith respect to compliance with the Marketing Authorisation (where not includedunder 2.2).
简述委托方和受托方在产品放行中的责任（不包括在2.2中）。
质量风险管理（QRM）
- Briefdescription of QRM methodologies used by the manufacturer;
简述企业质量风险管理方法
- Scopeand focus of QRM including brief description of any activities which areperformed at corporate level, and those which are performed locally. Anyapplication of the QRM system to assess continuity of supply should bementioned.
按公司不同层级（集团和生产厂）简述质量风险管理的范围和重点，包应提及任何评估供应持续性的质量风险管理体系应用。
人员
- Organisationchart showing the arrangements for quality management, production and qualitycontrol positions/titles in Appendix 5, including senior management andAuthorised Person(s) / Qualified Person(s);
企业质量管理、生产和质量控制及其负责人的组织机构图，包括高级管理层和授权人等（附件5）；
- Numberof employees engaged in the quality management, production, quality control,storage and distribution respectively.
从事质量管理、生产、质量控制、储存及分销的员工数量。
厂房和设备
厂房
- Short description of plant; size of the site andlist of buildings. If the production for different markets, i.e. for local, EU,USA, etc. takes place
indifferent buildings on the site, the buildings should be listed with
destinedmarkets identified (if not identified under 1.1);
简述生产工厂情况，包括场地面积和各建筑物名称等，如不同建筑物生产的品种面向当地以及欧盟、美国等不同市场，应在特定市场的建筑物上注明（如未在1.1明确）
- Simpleplan or description of manufacturing areas with indication of scale(architectural or engineering drawings are not required); Lay outs and flowcharts of the production areas (in Appendix 6) showing the room classificationand pressure differentials between adjoining areas and indicating theproduction activities (i.e.compounding, filling, storage, packaging, etc.) in therooms;
简述生产区域规模情况，附厂区总平面布局图、生产区域的平面布局图和流向图，标明比例（不需要建筑或工程图纸）。应当标注出房间的洁净级别、相邻房间的压差，并且能指示房间所进行的生产活动（例如：配料、灌装、储存、包装等）（附件6）；
Lay-outs of warehouses andstorage areas, with special areas for the storage and handling of highly toxic,hazardous and sensitising materials indicated, if applicable;
仓库和储存区域的平面图，如果有，包括储存和处理高毒性、危险性与敏感物料的特殊区域。
- Briefdescription of specific storage conditions if applicable, but not indicated onthe lay-outs.
如有，请简述特殊储存条件情况，但不需在平面图上注明。
简述空调净化（HVAC）系统
- Principlesfor defining the air supply, temperature, humidity, pressure
differentials and air change rates, policy of airrecirculation (%).
简述空调净化系统设计原则，如送风、温度、湿度、压力差以及换气次数、回风等 (%)。
简要描述水系统
- Qualityreferences of water produced;
水质设计标准
- Schematicdrawings of the systems in Appendix 7.
水系统示意图附录7
4.1.3. Brief description of other relevant utilities,such as steam, compressed air,
nitrogen,etc.
简要描述其它相关公用设施，例如蒸汽、压缩空气、氮气等系统。
设备
pieces of equipmentidentified should be provided in Appendix 8.
列出生产和检验用主要仪器、设备附录8。
清洁与消毒
- Brief description of cleaning and sanitationmethods of product contact
surfaces(i.e. manual cleaning, automatic Clean-in-Place, etc).
简述与药品直接接触设备、工器具的表面清洗、消毒方法及验证情况（例如：人工清洁、自动在线清洁等）。
与药品生产质量相关的关键计算机化系统
- Description of GMP critical computerised systems (excluding equipment
specific Programmable Logic Controllers (PLCs)).
简述与药品生产质量相关的关键的计算机化系统情况（不包括逻辑编程器（PLCs））。
文件
- Descriptionof documentation system (i.e. electronic, manual);
描述企业的文件系统（例如电子、纸质）；
- Whendocuments and records are stored or archived off-site (includingpharmacovigilance data, when applicable): List of types of documents/records;Name and address of storage site and an estimate of time required retrievingdocuments from the off-site archive.
如文件和记录在生产工厂外保存（如有，包括药物警戒数据），请提供外存的文件/记录目录、储存场所的名称和地址以及从厂区外取回文件所需的时间。
生产
产品类型
(references to Appendix 1or 2 can be made):
（可参考附件1或2）：
- Typeof products manufactured including
生产品种类型
▪ list of dosage forms of both human and veterinaryproducts which are
manufactured on the site
工厂生产剂型一览表（包括人用与兽用产品）
▪ list of dosage forms ofinvestigational medicinal products (IMP)
manufactured for any clinical trials on the site, and when differentfrom
thecommercial manufacturing, information of production areas and
personnel
工厂生产临床试验用药品（IMP）剂型一览表，如生产场所与上市生产品种不同，请提供生产区域和生产人员信息。
- Toxicor hazardous substances handled (e.g. with high pharmacological activity and/orwith sensitising properties);
毒性或危险物质的处理情况（如高活性和/或高致敏药品）；
- Producttypes manufactured in a dedicated facility or on a campaign basis, ifapplicable;
如有，请说明专用设备或阶段生产制造产品情况；
- ProcessAnalytical Technology (PAT) applications, if applicable: general statement ofthe relevant technology, and associated computerised systems.
如有，请说明过程分析技术（PAT）应用情况，并概述相关技术和计算机化系统应用情况。
工艺验证
- Briefdescription of general policy for process validation;
简要描述工艺验证的原则；
- Policyfor reprocessing or reworking.
返工或重新加工的原则。
物料管理和仓储
- Arrangementsfor the handling of starting materials, packaging materials, bulk and finishedproducts including sampling, quarantine, release and storage;
起始物料、包装材料、半成品与成品的处理，包括取样、待检、放行与储存；
- Arrangementsfor the handling of rejected materials and products.
不合格物料和产品的处理
质量控制
- Descriptionof the Quality Control activities carried out on the site in terms of physical,chemical, and microbiological and biological testing.
描述理化检验、微生物及生物学检验等质量控制活动。
分销、投诉、产品缺陷与召回
分销（属于制造商职责内的部分）
- Types(wholesale licence holders, manufacturing licence holders, etc) and locations(EU/EEA, USA, etc.) of the companies to which the products are shipped from thesite;
分销商类型（包括是否持有经营许可证或制造许可证等）及其所在地区（欧盟/欧洲经济区、美国等）；
- Descriptionof the system used to verify that each customer / recipient is
legally entitled to receive medicinal products fromthe manufacturer;
描述用来确认顾客/接受者的系统，以证明顾客有合法资格接收药品；
- Briefdescription of the system to ensure appropriate environmental
conditions during transit, e.g. temperature monitoring/ control;
简要描述产品在运输过程中确保其符合贮存条件要求的的措施，例如：
温度监测/监控；
- Arrangementsfor product distribution and methods by which product
traceabilityis maintained;
- 产品分销管理以及确保其可追踪的方法。
-Measures taken toprevent manufacturers’ products to fall in the illegal
supplychain
防止产品流入非法供应链的措施。
投诉、产品缺陷与召回
- Briefdescription of the system for handling complains, product defects
and recalls.
简要描述投诉处理、产品缺陷与召回系统。
自检
- Shortdescription of the self inspection system with focus on criteria used forselection of the areas to be covered during planned inspections, practicalarrangements and follow-up activities.
简要描述企业自检系统，重点说明自检计划中涉及范围的选择标准、自检实施以及整改情况。
相关附件：
Appendix 1 Copy of valid manufacturing authorisation
附件1 有效的制造许可文件复印件
Appendix 2 List of dosage forms manufactured including the INN-names or
common name (as available) of active pharmaceutical ingredients
(API) used
附件2 所有生产剂型目录，包括所用原料药的INN名称或通用名（如有）
Appendix 3 Copy of valid GMP Certificate
附件3 有效的GMP证书复印件
Appendix 4 List of contract manufacturers and laboratories including the
addresses and contact information, and flow-charts of the
supply chains for these outsourced activities
附件4 合同生产企业和实验室情况一览表，包括地址和联系信息以及外包活动的供应链流程图。
Appendix 5 Organisational charts
附件5 组织机构图
Appendix 6 Layouts of production areas including material and personnel
flows, general flow charts of manufacturing processes of each
product type (dosage form)
附件6 生产区域平面图，包括物料和人员流向图，各类型（剂型）产品
生产工艺流程图
Appendix 7 Schematic drawings of water systems
附件7 水系统示意图
Appendix 8 List of major production and laboratory equipment
附件8 关键生产设备与实验室设备、仪器清单
二、CFDA2016年01月07日GMP批件、特药批件、药典会颁布件邮寄详情单
CFDA2016年01月07日GMP批件邮寄详情单 |
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2016年01月07日
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2016年01月05日-07特药批件邮寄详情单 |
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2016年01月07日
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序号
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | 哈尔滨经开区南岗集中区先锋路469号13号楼3层东侧厂房 | |
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序号
| | | | | | | | | | | | | | | | | | | | | | | | | | | | 江苏省南通市如东沿海经济开发区海滨三路与通海二路交界路口（2-02#） | | | | | | | | | | | | | | | 浙江省新昌县南明街道人民东路127号佳艺东都金座10B-6 | | | | | | | | | | | | | | | | | | | | 深圳市福田区福中三路1006号诺德金融中心15层C.D单元 | | | | | 北京市通州区中关村科技园区通州园金桥科技产业基地景盛南四街13号20号厂房 | | | | | | | | | | | | | | | | | | | | | | | | | 广州市番禺区东环街新骏一街16号2座1115-1116房 | | | | | | | | | | 北京市通州区中关村科技园区通州园金桥科技产业基地景盛南四街13号20号厂房 | | | | | 深圳市福田区福中三路1006号诺德金融中心15层C.D单元 | | | | | 北京市通州区中关村科技园区通州园金桥科技产业基地景盛南四街13号20号厂房 | | | | | 深圳市福田区福中三路1006号诺德金融中心15层C.D单元 | | | | | 北京市通州区中关村科技园区通州园金桥科技产业基地景盛南四街13号20号厂房 | | | | | 深圳市福田区福中三路1006号诺德金融中心15层C.D单元 | | | | | | | | | | 哈尔滨经开区南岗集中区先锋路469号13号楼3层东侧厂房 | | | | | 哈尔滨经开区南岗集中区先锋路469号13号楼3层东侧厂房 | | | | | 北京市通州区中关村科技园区通州园金桥科技产业基地景盛南四街13号20号厂房 | | | | | 北京市通州区中关村科技园区通州园金桥科技产业基地景盛南四街13号20号厂房 | | | | | 北京市通州区中关村科技园区通州园金桥科技产业基地景盛南四街13号20号厂房 | |
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2016年01月06日药典会颁布件批件邮寄详情单 |
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2016年01月06日
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序号
| | | | | | | | | 1003411501619
1003411499619 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | 1003411480119
1003411486319 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | CYZB1308008苏 CYZB1307648苏 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | CYZB1307072蒙
CYZB1308391蒙 | | | | | CYZB1307075蒙
CYZB1308383蒙 | | | | | | | | | | | | | | | CYZB1307313蒙
CYZB1308379蒙
CYZB1308490蒙 | | | | | | | | | | | | | | | | | | | | | | |
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三、CFDA网站2016年第一周GMP公告汇总
[attach]7590[/attach]
来源：国家食品药品监督管理总局食品药品审核查验中心
国家食品药品监督管理总局
免责声明：编辑对上述内容，对文中陈述、观点判断保持中立，不对所包含内容的准确性、可靠性或完整性提供任何明示或暗示的保证。仅作参考，并请各位自行承担全部责任。
作者: xiaomihu 时间: 2016-1-8 09:13 AM
谢谢楼主分享
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