精神药品咖啡因QC实验室管理规范化建设与实践
发布时间：2019-05-22 06:38
【摘要】：随着对药品质量监管力度的不断加大和法规的不断完善,如何保证药品质量和生产符合GMP (Good Manufacture Practices,药品生产质量管理规范)是制药企业必须面对的一个问题。随着我国原料药生产企业对国际市场的不断开拓,与国外厂家的合作越来越多,国外客户及官方对原料药供应商的质量监督也越来越严格。QC (Quality Control,质量控制)实验室做为GMP六大体系之一,不管是在客户审计还是在FDA (Food and Drug Administration,美国食品与药品监督管理局)、EDQM (European Directorate for Quality Medicines,欧洲药品质量管理局)等大型官方审计中,都是一个必审查环节。虽然各国各个审计人员的侧重点不同,但是审计人员进入现场检查的时候,都按照ICH (International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use,人用药物注册技术要求国际协调会议)-Q7A涵盖GMP六大体系[1],因此作为制药企业对QC实验室管理必须以ICH法规为依据,研究和建立相应的QC实验室管理标准并执行到位,才能满足国际水平的审计要求,为产品开拓国际市场奠定基础。 咖啡因作为一种精神类原料药,其管理不同于普通原料药,本文以咖啡因为例,依据精神药品管理法规及ICH法规要求,研究并制定一套精神类原料药QC实验室管理标准,并结合本人多年工作经验和体会,研究分析FDA、EDQM两大官方审计和重大客户审计提出的问题,对整套管理标准进行完善,使其能够满足QC实验室管理的要求,为质量控制提供保障。 本文,首先对国内QC实验室管理现状进行概述,由于ICH法规和GMP对QC实验室的管理部分描述的都较为笼统,导致很多实验室在管理中存在诸多脱离甚至背离规范要求的地方即QC实验室管理不规范之处；其次,以咖啡因为例,依据其检测流程,将QC实验室管理分为人员管理、取样管理、留样管理、检测管理、出具报告单管理五个环节,对每个环节进行细致的风险分析,贯穿ICH法规和GMP要求制定符合GMP管理规范要求的一套针对细节管理和过程风险控制的管理规程,并实施；再次借助FDA、EDQM和重大客户审计提出的问题和缺陷查找不足,制定解决方案,以完善整个QC实验室的管理体系；最终对全文进行总结。 QC实验室作为GMP六大体系之一,作为审计的必审环节,其管理的规范性是重中之重,是其作为质量控制最后一道关卡成败的关键因素。本文旨在以咖啡因通过FDA、EDQM认证为例,参考ICH法规和精神药品管理办法制定出一套适合精神类原料药的实验室管理规程,以期为国内精神类原料药生产企业提供参考,使其在精神类原料药QC实验室管理过程中,少走弯路,加快实验室管理水平提高的步伐,为产品在国际市场的竞争中抢占先导地位。
[Abstract]:With the increasing supervision of drug quality and the continuous improvement of laws and regulations, how to ensure that drug quality and production comply with GMP (Good Manufacture Practices, drug production quality management specification) is a problem that pharmaceutical enterprises must face. With the continuous development of international market by raw material drug manufacturers in China, there are more and more cooperation with foreign manufacturers, and the quality supervision of raw material drug suppliers by foreign customers and officials is becoming more and more strict. QC (Quality Control, Quality Control (quality Control) Laboratory is one of the six GMP systems, whether in customer audits or in large official audits such as the FDA (Food and Drug Administration, Food and Drug Administration), EDQM (European Directorate for Quality Medicines, European Drug quality Administration). Are all a must-have review link. Although the focus of auditors varies from country to country, auditors enter the site in accordance with ICH (International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, The International Coordinating meeting on Technical requirements for Human Drug Registration)-Q7A covers the six QC systems [1]. Therefore, as a pharmaceutical enterprise, the QC laboratory management standards must be studied and established and implemented on the basis of GMP regulations and regulations. In order to meet the international level of audit requirements, for products to open up the international market to lay the foundation. As a kind of mental API, the management of caffeine is different from that of ordinary API. Taking caffeine as an example, according to the requirements of psychotropic drug management regulations and ICH regulations, this paper studies and formulates a set of laboratory management standards of mental API QC. Combined with my many years of working experience, this paper studies and analyzes the problems put forward by the two official audits and major customer audits of FDA,EDQM, and perfects the whole set of management standards so that they can meet the requirements of QC laboratory management. To provide assurance for quality control. In this paper, first of all, the current situation of QC laboratory management in China is summarized. Because of the ICH regulations and GMP's management part of QC laboratory, it is more general. As a result, there are many places in the management of many laboratories that are divorced from or even deviate from the requirements of the specification, that is, the management of QC laboratories is not standardized. Secondly, taking caffeine as an example, according to its testing process, the QC laboratory management is divided into five links: personnel management, sampling management, sample retention management, testing management, report form management, and detailed risk analysis of each link. Through ICH regulations and GMP requirements to develop a set of management rules for detail management and process risk control, which meet the requirements of GMP management specifications, and implement them. Thirdly, with the help of FDA,EDQM and major customer audit, the problems and defects are found out, and the solutions are worked out to improve the management system of the whole QC laboratory. Finally, the full text is summarized. As one of the six systems of GMP, QC laboratory, as the necessary audit link, the standardization of its management is the most important, and it is the key factor for the success or failure of QC laboratory as the last level of quality control. Taking caffeine passing FDA,EDQM certification as an example, referring to ICH regulations and psychotropic drug management measures, this paper aims to formulate a set of laboratory management rules suitable for mental API, in order to provide reference for domestic mental API manufacturers. In the process of mental API QC laboratory management, it should take less detours and speed up the improvement of laboratory management level, so that the products can occupy the leading position in the competition of the international market.
【学位授予单位】：山东大学
【学位级别】：硕士
【学位授予年份】：2014
【分类号】：R95
本文编号：2482754
[Abstract]:With the increasing supervision of drug quality and the continuous improvement of laws and regulations, how to ensure that drug quality and production comply with GMP (Good Manufacture Practices, drug production quality management specification) is a problem that pharmaceutical enterprises must face. With the continuous development of international market by raw material drug manufacturers in China, there are more and more cooperation with foreign manufacturers, and the quality supervision of raw material drug suppliers by foreign customers and officials is becoming more and more strict. QC (Quality Control, Quality Control (quality Control) Laboratory is one of the six GMP systems, whether in customer audits or in large official audits such as the FDA (Food and Drug Administration, Food and Drug Administration), EDQM (European Directorate for Quality Medicines, European Drug quality Administration). Are all a must-have review link. Although the focus of auditors varies from country to country, auditors enter the site in accordance with ICH (International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, The International Coordinating meeting on Technical requirements for Human Drug Registration)-Q7A covers the six QC systems [1]. Therefore, as a pharmaceutical enterprise, the QC laboratory management standards must be studied and established and implemented on the basis of GMP regulations and regulations. In order to meet the international level of audit requirements, for products to open up the international market to lay the foundation. As a kind of mental API, the management of caffeine is different from that of ordinary API. Taking caffeine as an example, according to the requirements of psychotropic drug management regulations and ICH regulations, this paper studies and formulates a set of laboratory management standards of mental API QC. Combined with my many years of working experience, this paper studies and analyzes the problems put forward by the two official audits and major customer audits of FDA,EDQM, and perfects the whole set of management standards so that they can meet the requirements of QC laboratory management. To provide assurance for quality control. In this paper, first of all, the current situation of QC laboratory management in China is summarized. Because of the ICH regulations and GMP's management part of QC laboratory, it is more general. As a result, there are many places in the management of many laboratories that are divorced from or even deviate from the requirements of the specification, that is, the management of QC laboratories is not standardized. Secondly, taking caffeine as an example, according to its testing process, the QC laboratory management is divided into five links: personnel management, sampling management, sample retention management, testing management, report form management, and detailed risk analysis of each link. Through ICH regulations and GMP requirements to develop a set of management rules for detail management and process risk control, which meet the requirements of GMP management specifications, and implement them. Thirdly, with the help of FDA,EDQM and major customer audit, the problems and defects are found out, and the solutions are worked out to improve the management system of the whole QC laboratory. Finally, the full text is summarized. As one of the six systems of GMP, QC laboratory, as the necessary audit link, the standardization of its management is the most important, and it is the key factor for the success or failure of QC laboratory as the last level of quality control. Taking caffeine passing FDA,EDQM certification as an example, referring to ICH regulations and psychotropic drug management measures, this paper aims to formulate a set of laboratory management rules suitable for mental API, in order to provide reference for domestic mental API manufacturers. In the process of mental API QC laboratory management, it should take less detours and speed up the improvement of laboratory management level, so that the products can occupy the leading position in the competition of the international market.
【学位授予单位】：山东大学
【学位级别】：硕士
【学位授予年份】：2014
【分类号】：R95
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