精神藥品咖啡因QC實(shí)驗(yàn)室管理規(guī)范化建設(shè)與實(shí)踐
發(fā)布時(shí)間：2019-05-22 06:38
【摘要】：隨著對(duì)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(duì)的一個(gè)問題。隨著我國(guó)原料藥生產(chǎn)企業(yè)對(duì)國(guó)際市場(chǎng)的不斷開拓,與國(guó)外廠家的合作越來越多,國(guó)外客戶及官方對(duì)原料藥供應(yīng)商的質(zhì)量監(jiān)督也越來越嚴(yán)格。QC (Quality Control,質(zhì)量控制)實(shí)驗(yàn)室做為GMP六大體系之一,不管是在客戶審計(jì)還是在FDA (Food and Drug Administration,美國(guó)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(jì)中,都是一個(gè)必審查環(huán)節(jié)。雖然各國(guó)各個(gè)審計(jì)人員的側(cè)重點(diǎn)不同,但是審計(jì)人員進(jìn)入現(xiàn)場(chǎng)檢查的時(shí)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(cè)技術(shù)要求國(guó)際協(xié)調(diào)會(huì)議)-Q7A涵蓋GMP六大體系[1],因此作為制藥企業(yè)對(duì)QC實(shí)驗(yàn)室管理必須以ICH法規(guī)為依據(jù),研究和建立相應(yīng)的QC實(shí)驗(yàn)室管理標(biāo)準(zhǔn)并執(zhí)行到位,才能滿足國(guó)際水平的審計(jì)要求,為產(chǎn)品開拓國(guó)際市場(chǎng)奠定基礎(chǔ)。 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?yàn)槔?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(shí)驗(yàn)室管理標(biāo)準(zhǔn),并結(jié)合本人多年工作經(jīng)驗(yàn)和體會(huì),研究分析FDA、EDQM兩大官方審計(jì)和重大客戶審計(jì)提出的問題,對(duì)整套管理標(biāo)準(zhǔn)進(jìn)行完善,使其能夠滿足QC實(shí)驗(yàn)室管理的要求,為質(zhì)量控制提供保障。 本文,首先對(duì)國(guó)內(nèi)QC實(shí)驗(yàn)室管理現(xiàn)狀進(jìn)行概述,由于ICH法規(guī)和GMP對(duì)QC實(shí)驗(yàn)室的管理部分描述的都較為籠統(tǒng),導(dǎo)致很多實(shí)驗(yàn)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(shí)驗(yàn)室管理不規(guī)范之處；其次,以咖啡因?yàn)槔?依據(jù)其檢測(cè)流程,將QC實(shí)驗(yàn)室管理分為人員管理、取樣管理、留樣管理、檢測(cè)管理、出具報(bào)告單管理五個(gè)環(huán)節(jié),對(duì)每個(gè)環(huán)節(jié)進(jìn)行細(xì)致的風(fēng)險(xiǎn)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(duì)細(xì)節(jié)管理和過程風(fēng)險(xiǎn)控制的管理規(guī)程,并實(shí)施；再次借助FDA、EDQM和重大客戶審計(jì)提出的問題和缺陷查找不足,制定解決方案,以完善整個(gè)QC實(shí)驗(yàn)室的管理體系；最終對(duì)全文進(jìn)行總結(jié)。 QC實(shí)驗(yàn)室作為GMP六大體系之一,作為審計(jì)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(guān)卡成敗的關(guān)鍵因素。本文旨在以咖啡因通過FDA、EDQM認(rèn)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(shí)驗(yàn)室管理規(guī)程,以期為國(guó)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(shí)驗(yàn)室管理過程中,少走彎路,加快實(shí)驗(yàn)室管理水平提高的步伐,為產(chǎn)品在國(guó)際市場(chǎng)的競(jìng)爭(zhēng)中搶占先導(dǎo)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(xué)位授予單位】：山東大學(xué)
【學(xué)位級(jí)別】：碩士
【學(xué)位授予年份】：2014
【分類號(hào)】：R95
本文編號(hào)：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(xué)位授予單位】：山東大學(xué)
【學(xué)位級(jí)別】：碩士
【學(xué)位授予年份】：2014
【分類號(hào)】：R95
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