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FDA认证咨询/FDA开发(cGMP)行业指南的法规原因和技术原因

来源:本站 作者:ADMIN 发布时间:2020-01-01


II.   Background      

      背景



Thissection describes briefly both the regulatory and technical reasons why theAgency is developing this guidance document.


本章简要描述FDA开发本行业指南的法规原因和技术原因。        


       A.Regulatory Framework

法规架构




Thisguidance pertains to current good manufacturing practice (CGMP) regulations (21CFR parts 210 and 211) when manufacturing sterile drug and biological productsusing aseptic processing.  Although thefocus of this guidance is on CGMPs in 21 CFR 210 and 211, supplementaryrequirements for biological products are in 21 CFR 600-680.  For biological products regulated under 21CFR parts 600 through 680, §§ 210.2(a) and 211.1(b) provide that where it isimpossible to comply with the applicable regulations in both parts 600 through680 and parts 210 and 211, the regulation specifically applicable to the drugproduct in question shall supercede the more general regulations.


本指南符合使用无菌加工生产无菌药品和生物制品过程中的cGMP法规要求(21 CFR210211节)。此指南的重点是21 CFR 210211节内的cGMP要求,生物制品的补充要求见21 CFR600 - 680节。对于受21 CFR 600 - 680节管制的生物制品,§§ 210.2(a)211.1(b)规定:在无法同时符合600 –680节和210211节相关要求的情况下,适用于所述药品的具体规定应当代替一般性规定。



B.     Technical Framework

             技术架构




Thereare basic differences between the production of sterile drug products usingaseptic processing and production using terminal sterilization.  


在使用无菌加工生产的无菌药品生产与使用最终灭菌生产的无菌药品生产之间,有根本性的区别。


Terminalsterilization usually involves filling and sealing product containers underhigh-quality environmental conditions. Products are filled and sealed in thistype of environment to minimize the microbial and particulate content of thein-process product and to help ensure that the subsequent sterilization processis successful. In most cases, the product, container, and closure have lowbioburden, but they are not sterile. The product in its final container is thensubjected to a sterilization process such as heat or irradiation.  


最终灭菌通常涉及在高质量环境条件下分装和封口产品容器。在这种类型环境下分装和封口产品,以最小化中间产品内的微生物和颗粒含量,并帮助确保随后的灭菌工艺成功。在大多数情况下,产品、容器和密封的生物负载低,但并非无菌。在最终容器内的产品随后进入灭菌工艺,例如加热或放射灭菌。

sterilizethe product in its final container, it is critical that containers be filledand sealed in an extremely high-quality environment.  Aseptic processing involves more variablesthan terminal sterilization. Before aseptic assembly into a final product, theindividual parts of the final product are generally subjected to varioussterilization processes.  For example,glass containers are subjected to dry heat; rubber closures are subjected tomoist heat; and liquid dosage forms are subjected to filtration.  Each of these manufacturing processesrequires validation and control.  Eachprocess could introduce an error that ultimately could lead to the distributionof a contaminated product.  Any manual ormechanical manipulation of the sterilized drug, components, containers, orclosures prior to or during aseptic assembly poses the risk of contaminationand thus necessitates careful control.  Aterminally sterilized drug product, on the other hand, undergoes finalsterilization in a sealed container, thus limiting the possibility of error.[1]

在无菌加工中, 药品、容器和密封首先分别使用合适方法灭菌,然后组合到一起。[2]由于没有在最终容器内灭菌药品的工艺,因此在特别高质量的环境中分装和封口容器是非常关键的。无菌加工涉及的变量比最终灭菌更多。在无菌组装成最终产品之前,最终产品的各个组成部分通常进入不同的灭菌工艺。比如:玻璃容器进行干热灭菌 ,橡胶密封进行蒸汽灭菌,液体剂型则进行过滤。每个生产工艺都需要验证及控制。每个过程都有可能出现误差,从而最终导致污染药品上市。在无菌装配之前或期间,已灭菌药品、成分、容器或密封的任何手工或机器操作都有污染的风险,因此需要加以仔细控制。而最终灭菌的药品在密封容器中进行最终灭菌,因此限制了出错的可能。[3]


Sterile drug manufacturers should have akeen awareness of the public health implications of distributing a nonsterileproduct.  Poor CGMP conditions at amanufacturing facility can ultimately pose a life-threatening health risk to apatient.  


无菌药品生产商应该清楚地认识到销售非无菌药品所造成的公众安全影响。生产设施的劣质cGMP条件可能最终给患者带来危及生命的风险。







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