EU-GMP欧盟药品生产质量管理规范.ppt_第1页
EU-GMP欧盟药品生产质量管理规范.ppt_第2页
EU-GMP欧盟药品生产质量管理规范.ppt_第3页
EU-GMP欧盟药品生产质量管理规范.ppt_第4页
EU-GMP欧盟药品生产质量管理规范.ppt_第5页
已阅读5页,还剩68页未读 继续免费阅读

下载本文档

版权说明:本文档由用户提供并上传,收益归属内容提供方,若内容存在侵权,请进行举报或认领

文档简介

GMP,Good Manufacturing Practice (优良的生产实践)药品生产质量管理规范 Seminar for the whole Workforce 职工整体培训,Shanghai Jinji Business Consulting 上海金冀商务咨询有限公司,General Manager 中国地区总经理 Dr. Hartmut Steinel 石泰牛 博士 B.Sc. & M.Sc. (University of Ulm, Germany) Ph.D. (University of Sydney, Australia) Nationality: German 国籍 德国 Drafted this seminar 起草该培训资料,GMP Part I,Good Manufacturing Practice (优良的生产实践)药品生产质量管理规范 Procedures & General Regulations 程序&法规概要,G M P “Good Manufacturing Practice” means that a pharmaceutical manufacturer proves that he is in control of all processes involved to manufacture a medicine and can guarantee that the final product complies with all requirements. “国际GMP标准”是所有在西方国家市场上销售药品和医疗器械的强制性生产制造标准。 “(优良的生产实践)药品生产质量管理规范”表示一个制药企业有能力加工某种药品,并且可以保证最终的产品符合所有的要求。,The Manufacturer guarantees 制造商保证成品是,the quality, strength and purity as registered, 质量,浓度,纯度与注册的一致, manufactured, tested, packed and finally assed before release, 放行前已经完成加工,检测,包装和最终评估, and all raw material, intermediates and the finished product have been tested and comply with the registration requirements. 所有的原料,中间体和成品已经进行检测并符合注册要求。,Government Authorities around the world are not satisfied by the word of anybody, they want to make sure that the pharmaceutical manufacturer is able to fulfill his guarantee. 全世界的政府权威部门对任何人的描述都不满意,他们希望确定医药制造商能够履行对于质量的保证。 To insure this guarantee, they have set up regulations for pharmaceutical manufacturers and they are sending inspectors in to check that these regulations are in place and not bypassed. 为了确保质量,他们制定了针对医药制造商的法规,并派遣审查官员检查这些法规的落实。,These inspectors or “auditors” as they are called will issue the GMP license after they have audited a manufacturing facility and have been satisfied that the audited pharmaceutical manufacturer can give the required guarantee. 这些检查员或“审计员”在检查过制造设备,并对提供质量保证满意后颁发GMP证书。,The certificate these auditors give to the pharmaceutical manufacturer is valid for 2 years. The auditors will return after 2 years, or if there is a major complaint. 该证书的有效期为2年,检查官会在2年后重新检查,或者当出现投诉的时候复查。 This certificate is called GMP license. 这就是GMP证书。,Now, every pharmaceutical manufacturer in the Peoples Republic of China has a GMP license from the Chinese SFDA. Therefore, there is no need to continue this presentation, 现在,每一家中国的制药企业都已经通过中国SFDA的检查并获得证书。因此,没有必要持续现状。 except, if you want to sell your products outside of China. 除非,您只希望在中国范围内销售您的产品。,To sell pharmaceutical products outside of China your sponsor or agent in the foreign country has to contact the inspection agency of his area and ask for an inspection of your Chinese factory。For Yangtze Group we will use Chem Swiss AG and the GMP certificate will look similar to this one. 为了将产品销往国外,你在国外的赞助商或代理商必须联系一个检查机构并为您的中国工厂申请检查。我们将用Chem Swiss AG为扬子江药业集团申请,GMP证书和以下证书大致一样。,This is the European GMP certificate of a Zhejiang company. According to European law all identifying names have to be deleted. 这是某浙江公司的证书。根据欧洲的法规我们删掉了一些部分。,We have entered Chinese subtitles for you. 我们做了一个中英文的对照版。,The Steps to receive the European GMP License (1) 取得欧洲GMP证书的步骤(1) The management of Yangtze Group has decided to apply, via Chem Swiss AG , for such a license. 扬子江药业集团的经理决定通过Chem Swiss AG申请证书。 They have asked Shanghai Jinji Business Consulting to organise everything to receive this license. 并邀请上海金冀咨询有限公司为取得证书组织所有的事宜。,The Steps to receive the European GMP License (1) 取得欧洲GMP证书的步骤(1) Based on the strength of Yangtze Group, we have decided to apply for the GMP license for the following products. 基于扬子江药业集团的实力,我们决定申请以下产品的GMP证书 Terbinafine hydrochloride 盐酸特比奈酚 Omeprazole 奥美拉唑,The Steps to receive the European GMP License (3) 取得欧洲GMP证书的步骤(3) Then we have secured distributors in Europe and discussed potential prices. These distributors have supplied Yangtze Group with their German/Swiss registration dossiers, according to which the tablets and capsules have to be manufactured. 然后我们的可靠的欧洲代理商将会讨论可能的价格。这些代理商会向扬子江药业集团提供需要生产的产品的欧洲的注册技术文件 Terbinafine hydrochloride 盐酸特比奈酚 Omeprazole 奥美拉唑,The Steps to receive the European GMP License (4) 取得欧洲GMP证书的步骤(4) Now you have to manufacture 3 “validation batches” for each product according to the recipe in the registration dossier. They have to be tested according to the specifications described in the dossier and the raw material has to be examined according to the European Pharmacopoeia. These batches and the data will be assessed by the inspector when he comes plus many other things. When the inspector is happy with the 3 batches, he will give you the license for this product. 你们必须按照技术文件上的配方为每个产品都生产3批“验证批”。然后按照技术文件的要求进行检测,原料按照欧洲药典的要求检测。检察官将会查看这些产品和数据以及其它相关的东西。如果检察官对这些批的产品满意,他将会给你们颁发证书。,Pharmaceutical Inspection Co-operation Scheme (1) 药品生产检查合作计划(1),Now, why would the management bother with some 100 million people, instead of concentrating on the local market of 1.4 billion? 试想,为什么要关注100,000,000 人,而不集中精力在有1.4亿人口的本地市场呢?,Pharmaceutical Inspection Co-operation Scheme (2) 药品生产检查合作计划(2),Because European pharmaceutical companies have successfully complained that it is not necessary to have first the Swiss, then the British, then the French, then the Italian, then the auditors to perform exactly the same inspection, PIC/S was founded. PIC Pharmaceutical Inspection Convention PIC/S Pharmaceutical Inspection Co-operation Scheme 因为欧洲制药公司不需要先通过瑞士,然后是英国,接下来是法国,意大利的检查,检查员只要使用同样的检查标准,于是PIC/S产生了。 PIC 药品生产检查协会 PIC/S 药品生产检查合作计划,Pharmaceutical Inspection Co-operation Scheme (3) 药品生产检查合作计划(3),PIC/S means that an inspection performed by the inspectors of one country is recognised by all other member states. One inspection is valid to sell your products in all other countries. In short, all Western countries except the USA and Japan. PIC/S表示由某一个国家的检查员执行的检查被所有的成员国认可。您只需要通过一个检查,就可以销售您的产品到所有的成员国。简单的说,就是所有的西方国家除了美国和日本。,PICS MEMBER COUNTRIES 药品生产检查合作组织成员国家 Australia 澳大利亚 Austria奥地利 Belgium 比利时 Canada 加拿大 Czech Republic捷克 Denmark丹麦 Finland 芬兰 France 法国 Germany德国 Greece 希腊 Hungary 匈牙利 Iceland 冰岛 Ireland 爱尔兰 Italy意大利 Liechtenstein列支敦 Malaysia马来西亚 Netherlands荷兰 Norway挪威 Portugal 葡萄牙 Romania罗马尼亚 Singapore 新加坡 Slovak Republic斯洛伐克 Spain西班牙 Sweden瑞典 Switzerland瑞士 United Kingdom英国 South Africa南非 There are further agreements with New Zealand, Bulgaria, most French colonies and several East Block countries. All new members of the EU, which joined in May 2004 have been automatically included via European Law. 协议国家还有新西兰,保加利亚和大多数法属殖民地以及几个东欧国家。所有在2004年加入欧盟的新成员国也签有协议。,If you have the GMP certificate issued by the auditors of one of these countries you can automatically sell your products in all of these countries, under 2 conditions: 如果您获得这些国家中的一家权威机构颁发的GMP证书,就意味着你可以将产品销售到所以这些国家。 a) the product does not need special registration in the particular country. 您的产品在这些国家无需再做特别注册。 b) you must send a notarised copy of your GMP license to the country you intend to sell. 您只需发送公证过的GMP证书复印件到您想销售的国家.,Pharmaceutical Inspection Co-operation Scheme (4) 药品生产检查合作计划(4),This increases the number of persons from 100 million to more than 600 million. Additionally, prices of the pharmaceuticals in most of these European countries are much higher than in China. 人口的数量从100,000,000增长到600,000,000。而且,在欧洲大部分的国家,药品的价格比中国要高很多。,The international GMP license is like a drivers license. 国际GMP证书就象一张国际驾照。 It is completely irrelevant if you can drive or not. Without a license you are not allowed to drive. 这不是您可不可以驾驶的问题。而是没有这张驾照在法律上就意味着不允许驾驶。 The international license gives you permission to drive in all countries, but you have to drive according to the traffic regulations in the particular country. 这张国际驾照能让您在所有的国家行驶,但是您必须在不同的国家遵守不同的交通法规。 The drivers license is your personal property. It belongs to the inspected factory, not to the Holding company, not to the sponsor and not to the distributor. 这张驾照属于您个人。它属于被检查的工厂,不属于股份公司,不属于赞助商或经销商。,What is the difference between European and Chinese GMP? (1) 欧洲和中国GMP认证有哪些区别呢?(1) The “Site Master File” (Plant Master File) has a different format. “场地主要文件”(格式不同). All key documents have to be in English. 所有的主要文件都必须译成英文。 Some of the required documents have to contain more details than the documents prepared for the SFDA. 其中一些文件的内容要比递交中国SFDA的更详细。 You have to prepare some additional documents to explain some details in the factory, which the SFDA will find elsewhere based on their ability to read Chinese 要准备一些附加文件,以便解释工厂的一些细节,因为他们看不懂中文。 You have to show representative English “Drug Master Files”, sometimes of all your products. 您必须展示有代表性的“药品主要文件”,有时要附上您所有的产品。,What is the difference between the European and the Chinese GMP license? (2) 欧洲和中国GMP认证有哪些区别呢?(2),QQ CAR,POLO CAR,What is the difference between the European and the Chinese GMP license? (3) 欧洲和中国GMP认证有哪些区别呢?(3),As you can see with the cars, the difference is in quality and in the reliability of the product. The difference is not in the system or in manufacturing. If every single person and every department strives for a little bit more quality and reliability the result will match the right hand picture. 正象您看到的二辆车,区别是质量和产品的信誉。区别不是在系统上或制造上。如果每个人和部门都作出一点努力,我们的质量和信誉就会象右边的图片一样。,Any European company or the sponsor of the non-European company has to register the product (s) first. Without going into details, registration of a pharmaceutical product in all Western countries is 任何欧洲公司或非欧洲公司的主办人必须先注册产品,简单的说,在西方国家注册一种医药产品是 a) more expensive (much much more expensive), and 更加昂贵(非常非常昂贵) b) it takes longer to receive the registration. 得到注册需要很长的时间。 The same system applies also in the US; you have to register the product first. Then, after your sponsor has received the registration, he has to call the GMP inspectors. 在美国情况也是一样的,您必须先注册产品。然后,在您的主办人得到注册后,他必须申请GMP检查。,General Preparations (1) 常规准备(1),Most of you have experience with the Inspections by the Chinese State Food and Drug Administration, which are similar to the Swiss inspections. However, this time the inspectors do not speak Chinese and cannot read Chinese. 你们中的大多数都经历过中国国家食品药品监督管理局的检查,这和欧洲的检查很相似.但是,这次检查员不会讲中文,也看不懂中文.,General Preparations (2) 常规准备(2),This time, the inspectors will come from the Swiss SFDA. Therefore, everything has to be according to the Swiss regulations (most regulations are the same as the Chinese one) and the European Pharmacopoeia. However, you have to state that this time I manufacture according to the Swiss regulations or according to the European Pharmacopoeia (even if they are the same as the Chinese ones). 这次,检查员不是来自中国SFDA,而是来自欧洲SFDA。因此,每件事必须符合欧洲法规(大多数法规和中国的是一样的)。然而,您必须声明这次我是按照欧洲的法规进行生产的(即使是和中国的法规一样)。,General Preparations (3) 常规准备(3),During the inspection we will be in your factory, together with the inspectors. We will also supply you with suitable interpreters, if required. 在检查期间,我们也将在你们厂陪同检察官.随行人员还有GMP翻译.如果需要,我们也将提供适当的翻译员。,General Preparations (4) 常规准备(4),As it is described in the GMP requirements, we have to show “that we are in control”. We are in control regarding English documents, regarding production, regarding validations etc. and we want to be better than any Swiss company. This requires smart thinking and hard work. 正像GMP要求中描述的,我们必须显示出“一切都在我们的掌握当中”。关于英文的文件、生产和验证等等都已经准备充分。我们可以做的比任何一家欧洲公司做的更好。这就需要开放的思维和勤奋的工作。,Very Important,The most important is Clean. All room and equipment in the workshop should be extremely clean during the inspection. 清洁是最重要的。在检查期间车间内的房间和设备要彻底清洁。,Official Welcome 正式的欢迎仪式,The first working day in the factory, they usually start with a formal welcome with the General Manager and the Vice-Managers or Directors and all key personnel. There the auditors usually introduce themselves, give you a short GMP introduction and tell you their schedule, based on the “Site Master File”. In general, they prefer to start with the inspection of the ware house for raw material, followed by the packaging materials. 由总裁、副总裁或董事出席的一个正式的欢迎仪式,是检查工作的一个良好开端。在管理层会议后,召开所有主要工作人员会议。会议上,审计员通常先自我介绍,然后做一个简短的GMP介绍,描述他们的时间表,这取决于“场地主要文件”。通常情况下,他们希望从检查原材料仓库开始,然后是包装材料库。,After the inspection has been completed, the inspectors will hold a meeting and tell you all their complains, which are called deficiencies. They will give you a timeline for changing these deficiencies. They will also tell you that you have passed the inspection, after changing these deficiencies. That means, that you will hold the GMP license in your hands between 6 10 weeks after this meeting. 检查结束后,检查员将召开会议,告诉您他们所有的意见,也就是贵工厂的不足。他们将给您一个时间范围来弥补这些不足。整改之后,他们也同样会告诉您,您已经通过了检查。也就是说,您将在会议后的610周内得到GMP证书。,Another step 下一步,The inspectors always find a number of deficiencies. Some 15 45. That is the normal procedure. Small changes in some SOPs, a log book table, minor changes of the production etc. Additionally, they give you suggestions how to improve the running of the workshops. On rare occasions, this suggestions can even save you money. Dont hesitate to ask for advise. 检查员通常寻找一些小问题。一般1035个。那是常规的程序。一些SOP文件、台帐表和生产上等等需要一些小的改变。此外,他们会建议您如何改进车间的运行。很少的情况下,这些建议可以帮助您节约成本。您可以要求检查员提供建议。,GMP Part III,Good Manufacturing Practice (优良的生产实践)药品生产质量管理规范 The Inspection 检查,Entering the Workshop (1) 进入车间,It is very important to treat the auditors as described in the Standard Operation Procedures for visitors (they have to sign all forms required and the relevant officers of your company have to countersign). Then we suggest that you address the auditors and ask: “Usually our visitors will receive instruction how to behave in the workshops. This will take about 30 min. Because you are very familiar with GMP regulations and workshops, and have only a limited time to spend, we suggest to skip this introduction. Is this acceptable with you?” Very likely they will answer with “yes”, but it is important that you ask this question. 像针对来访者的标准操作程序中描述的一样接待审查员是非常重要的(他们必须签署所有要求的表格,贵公司的相关官员必须副署。)然后我们建议您询问审查员:“通常我们的来访者将收到在车间的正确行为说明。这需要大约30分钟。因为您非常熟悉GMP法规和车间,并且时间有限,我们建议省略这张说明。您认为可以吗?”他们非常有可能回答“好的”,但是您的这个问题是非常重要的。,Inside the Workshop (2) 车间内,The auditors prefer very much to see all your staff and all the machines in action. However, they understand that this is not always possible and they also understand that they are usually disturbing your production. If possible, you should manufacture these days something very simple or do a test run. 审查员愿意看到所有的职员和机器都在运作。然而,他们理解这种情况不是持续发生的,他们也同样理解他们的到来会打扰职员的工作。如果有可能,这几天您应该生产一些非常简单的产品或者做一个测试性的运作。,Inside the Workshop (3) 车间内,The designated staff has to be next to each machine (even if the machine is not used this day). They have the production process for a particular product near them in the designated place. The auditors will ask some of the staff regarding details of the production process and they will definitely ask questions regarding the cleaning procedures. They use an interpreter for this questioning and they will also ask for translations of one or the other SOP involved. 相关的人员必须站在每台机器旁(即使这台机器当天没有使用)。在靠近他们的指定地点要有一份产品的生产程序。审查员将会询问一些员工关于生产程序的细节问题,很明显他们将会问一些关于清洁程序的问题。他们请一位翻译员来问这些问题,他们也会要求查看一个或多个标准操作程序的翻译文件。,Inside the Workshop (4) 车间内,All workers have to be prepared for questions regarding the SOPs of the 所有的员工必须准备关于标准操作规程的问题 machinery机器 cleaning of machinery and room机器和房间的清洁 exchange of status labels状态标签的更换 and the particular step in production which is just running in their room. 正在运行的生产步骤,Inside the Workshop (5) 车间内,The will ask questions about the in-process-control of this particular product and they want to see the records. They will also ask the QA officer how to test the balances each morning and where the records for all temperatures and humidity results are stored. 他们会提问关于某种产品的中间程序控制的问题,他们还会问QA官员每天早晨如何测试天平,所有的温湿度记录放在哪里.,Inside the Workshop (6) 车间内,The auditors will go through all rooms, look at each single machine and ask one or two questions via the interpreter. “All rooms” includes every cabinet, closet and laundry. 审查员将检查所有的房间,查看每一台机器,并且通过口译官提出一或二个问题。”所有的房间”包括柜子,壁柜和洗衣房.,Inside the Workshop (7) 车间内,They will check the SOPs and are very happy, if they have an English version of the production process of this particular product in hand, this includes starting material, in process controls and end control specification. 他们将核查标准操作程序,如果是某种产品的英文操作程序,他们会非常高兴,这包括原辅料预处理,中间过程控制和最终控制指标。,Inside the Workshop (8) 车间内,The auditors will follow the flowchart of the material and also the flowchart of the staff. It is a nice gesture, if you can provide them with a bound copy of the “Site Master File” and the floor plans of the workshops. Double locks are tested and special attention is paid to all balances and weighing stations. The auditors will always check the log books next to the balances. 审查员将实地考察人流物流走向。您应该提供他们“场地主要文件” 的副本和车间楼层平面图,这对检查很有帮助。他们会检查车间的气闸,以及特别注意所有的天平和称量站。审查员通常还要检查天平旁边的工作记录。,Inside the Workshop (9) 车间内,In the Intermediate Storage Area they will ask to see the log books for incoming and outgoing intermediates and incoming and outgoing final products. Different intermediates and products have to be separated clearly and labeled clearly. 在中间体存放区域,他们会要求检查中间体和成品(未包装成品)的进出记录.不同的中间体和成品必须清楚的分开,并且贴上标签.,Inside the Workshop (10) 车间内,Everything which is moved, whatever it is, need one inside and one outside label. 任何需移动的物料,其桶内外都必须有标签.,In process control testing station 在中间控制检测站内,The auditors will look at the log books and will ask for the calibration and validation of the equipment. 审查员将要求检查工作记录并要求设备校准和验证。,Inside the Storage Areas (1) 在储藏区域内,The auditors appreciate if they receive a copy of each single label for a particular product, including starting material and in process and end controls (tracking document) with the expected Chinese signatures on it. A few explanatory words in English on each of these papers will make them very happy. 审查员会非常高兴,如果他们看到某一个产品的各个标签的复印件,包括原辅料的预处理和中间控制和最终控制(跟踪性),这些标签上都应有中文签名。在这些标签上有一些英文注释会令审计员非常高兴。,Inside the Storage Areas (2) 在储藏区内,Although the coloured ribbons are very handy, each intermediate or product needs an additional label attached to one of the boxes. They will read selected labels and ask you to find the products in your computer system. 尽管用不同颜色的绳子分隔是非常容易的,但是每一个中间体或产品的盒子上需要额外贴上标签。他们会检查几个标签,然后在您的电脑系统中查找该产品.,Insid

温馨提示

  • 1. 本站所有资源如无特殊说明,都需要本地电脑安装OFFICE2007和PDF阅读器。图纸软件为CAD,CAXA,PROE,UG,SolidWorks等.压缩文件请下载最新的WinRAR软件解压。
  • 2. 本站的文档不包含任何第三方提供的附件图纸等,如果需要附件,请联系上传者。文件的所有权益归上传用户所有。
  • 3. 本站RAR压缩包中若带图纸,网页内容里面会有图纸预览,若没有图纸预览就没有图纸。
  • 4. 未经权益所有人同意不得将文件中的内容挪作商业或盈利用途。
  • 5. 人人文库网仅提供信息存储空间,仅对用户上传内容的表现方式做保护处理,对用户上传分享的文档内容本身不做任何修改或编辑,并不能对任何下载内容负责。
  • 6. 下载文件中如有侵权或不适当内容,请与我们联系,我们立即纠正。
  • 7. 本站不保证下载资源的准确性、安全性和完整性, 同时也不承担用户因使用这些下载资源对自己和他人造成任何形式的伤害或损失。

评论

0/150

提交评论