精神藥品咖啡因QC實驗室管理規(guī)范化建設與實踐
發(fā)布時間：2019-05-22 06:38
【摘要】：隨著對藥品質(zhì)量監(jiān)管力度的不斷加大和法規(guī)的不斷完善,如何保證藥品質(zhì)量和生產(chǎn)符合GMP (Good Manufacture Practices,藥品生產(chǎn)質(zhì)量管理規(guī)范)是制藥企業(yè)必須面對的一個問題。隨著我國原料藥生產(chǎn)企業(yè)對國際市場的不斷開拓,與國外廠家的合作越來越多,國外客戶及官方對原料藥供應商的質(zhì)量監(jiān)督也越來越嚴格。QC (Quality Control,質(zhì)量控制)實驗室做為GMP六大體系之一,不管是在客戶審計還是在FDA (Food and Drug Administration,美國食品與藥品監(jiān)督管理局)、EDQM (European Directorate for Quality Medicines,歐洲藥品質(zhì)量管理局)等大型官方審計中,都是一個必審查環(huán)節(jié)。雖然各國各個審計人員的側(cè)重點不同,但是審計人員進入現(xiàn)場檢查的時候,都按照ICH (International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use,人用藥物注冊技術要求國際協(xié)調(diào)會議)-Q7A涵蓋GMP六大體系[1],因此作為制藥企業(yè)對QC實驗室管理必須以ICH法規(guī)為依據(jù),研究和建立相應的QC實驗室管理標準并執(zhí)行到位,才能滿足國際水平的審計要求,為產(chǎn)品開拓國際市場奠定基礎。 咖啡因作為一種精神類原料藥,其管理不同于普通原料藥,本文以咖啡因為例,依據(jù)精神藥品管理法規(guī)及ICH法規(guī)要求,研究并制定一套精神類原料藥QC實驗室管理標準,并結(jié)合本人多年工作經(jīng)驗和體會,研究分析FDA、EDQM兩大官方審計和重大客戶審計提出的問題,對整套管理標準進行完善,使其能夠滿足QC實驗室管理的要求,為質(zhì)量控制提供保障。 本文,首先對國內(nèi)QC實驗室管理現(xiàn)狀進行概述,由于ICH法規(guī)和GMP對QC實驗室的管理部分描述的都較為籠統(tǒng),導致很多實驗室在管理中存在諸多脫離甚至背離規(guī)范要求的地方即QC實驗室管理不規(guī)范之處；其次,以咖啡因為例,依據(jù)其檢測流程,將QC實驗室管理分為人員管理、取樣管理、留樣管理、檢測管理、出具報告單管理五個環(huán)節(jié),對每個環(huán)節(jié)進行細致的風險分析,貫穿ICH法規(guī)和GMP要求制定符合GMP管理規(guī)范要求的一套針對細節(jié)管理和過程風險控制的管理規(guī)程,并實施；再次借助FDA、EDQM和重大客戶審計提出的問題和缺陷查找不足,制定解決方案,以完善整個QC實驗室的管理體系；最終對全文進行總結(jié)。 QC實驗室作為GMP六大體系之一,作為審計的必審環(huán)節(jié),其管理的規(guī)范性是重中之重,是其作為質(zhì)量控制最后一道關卡成敗的關鍵因素。本文旨在以咖啡因通過FDA、EDQM認證為例,參考ICH法規(guī)和精神藥品管理辦法制定出一套適合精神類原料藥的實驗室管理規(guī)程,以期為國內(nèi)精神類原料藥生產(chǎn)企業(yè)提供參考,使其在精神類原料藥QC實驗室管理過程中,少走彎路,加快實驗室管理水平提高的步伐,為產(chǎn)品在國際市場的競爭中搶占先導地位。
[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.
【學位授予單位】：山東大學
【學位級別】：碩士
【學位授予年份】：2014
【分類號】：R95
本文編號：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.
【學位授予單位】：山東大學
【學位級別】：碩士
【學位授予年份】：2014
【分類號】：R95
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