MWS 2 TRN 5105 BDP Pharma Industry Regulatory Perspective 制药行业管理看法 - 中文版
制药行业管理看法 Regulatory Perspective,Presented by- Jonathan Woodburn, Vice President, Compliance & Validation,管理看法Regulatory Perspective,制药工业的管理要求世界上几乎没有其他工业如制药工业一样接触如此多的人的健康和康乐。工业的快速成长需要一个管理部门，每天保护那些信任他们的人们。该部门就是FDA，创建于1910年的美国食品药品管理部门。FDA负责强迫所有的食品，药品和化妆品的供应和规范。现行的良好的制造过程（CGMP）是FDA规范的一部分，并解释FDA信任的GMP是什么，提供药物安全，纯净和高效生产的最低要求。,管理看法Regulatory Perspective,除了FDA之外，还有一些其他的区域性的管理药物制造的管理部门。我们将会在随后的幻灯片里简要地了解有关信息。制药工业内消费者的信任，基本上是由cGMP和FDA保证的。因此，制造一个新药或任何药，坚持管理要求是非常重要的。管理要求基本上指的是美国FDA规则。Code Of Federal Regulations (21CFR) was published by FDA, in SEP29 1978.,管理看法Regulatory Perspective,Title 21 Code of Federal Regulations Parts 210 & 211PART 210 & 211: The regulations set forth in these parts contain the minimum current good manufacturing practice for methods to be used in, and the facilities or controls to be used for, the manufacture, processing, packing, or holding of a drug to assure that such drug meets the requirements of the act as to safety and has the identity and strength and meets the quality and purity characteristics that it is represented to possess.The failure to comply with any regulations set forth in these parts then such drugs will be deemed adulterated under Section 501 (a)(2)(B) of the Federal Food, Drug and Cosmetic Act (the Act).The guidance given by the Act, for the manufacture of the API will be discussed briefly in the forthcoming sections.,管理看法Regulatory Perspective,FDA指导方针和展望Know the cGMP Regulations了解cGMP规范Comply with the cGMP Regulations符合cGMP规范Know your Products and Processes了解你的产品和工艺Communicate Problems to the Quality Unit与质量单位交流问题采取负责任的行动和正当文件需要一个系统来指导故障调查Consumer Protection is the Number One Goal保护消费者是第一目标,管理看法Regulatory Perspective,国际性管理部门和CGMP指导方针,管理看法Regulatory Perspective,cGMP Guidelines指导方针:FDA期望相关的cGMP指导方针适用于所有API制造工艺的所有步骤，开始于原料的使用。包括，API的纯度和与质量相关的工艺验证。FDA expects appropriate cGMPs to be applied to all steps of an API manufacturing process, beginning from the use of starting materials. This includes, the validation of processes determined to impact the quality and purity of the API.产品的质量基本上取决于这些生产的质量。多数失误是忽略的失误或是由于厌烦，粗心或不适当的指示而引起的委托失误，The quality of a product ultimately depends upon the quality of those producing it. Most errors are human errors of omission or commission due to boredom, carelessness or inadequate instructions.管理机构认可那些在API生产中cGMP指导方针的说服力，如书写的使用说明的范围，在线控制，取样，测试，监督和文件在工艺进程中从早期阶段到最后的合成和纯化阶段应该增加。The agency recognizes that the stringency of cGMPs in API production such as the extent of written instructions, in-processes controls, sampling, testing, monitoring and documentation should increase as the process proceeds from early stages to final synthesis and purification stages.API不是按照联邦食品药品和化妆品法案的cGMP指导方针制造的。APIs not manufactured in accordance with cGMPs are adulterated under Federal Food, Drug and Cosmetic Act.,管理看法Regulatory Perspective,API制造的主要cGMP准则如下：第一，最重要的，在没有记录，或证明文件，程序的情况下不会有任何东西被保证。First, and most important, that nothing should be undertaken without following the written, or documented, procedures.环境，设备，材料，标签和包装的质量控制检查必须在每个操作阶段都要执行。Quality Control checks of the environment, equipment, materials, labelling and packing must be carried out at every stage of operation.原料必须正确地进行储存和处理，所以正确的材料要一直精确使用。Raw materials must be stored and handled correctly, so that exactly the right materials can be used at all times.所有设施和设备，以及所在的环境一起需要适当的清洁和消毒。All facilities and equipments, together with the environment in which they are situated are to be properly cleaned and disinfected.生产和支持人员，必须按照需要着装和操作，应该需要适当的监督和正确培训。Both production and support staff, must dress and behave as required, should be properly supervised and correctly trained.所有工作必须被精确地保证。All work must be undertaken accurately and precisely.原料的污染，活性和非活性必须一直要防止。确保所有增加材料的正确性。Ensure that only the correct materials all added.确定在每个生产阶段每个项目要用适当的标签。每个动作要有精确的记录。Accurate records are to be kept for every activity.,管理看法Regulatory Perspective,API制造的指导方针Guidelines for API ManufactureCFR在第211部分为API的制造做了指导。这已经在联邦规范内做了精巧的讨论。Code of Federal Regulations has given the guidance for the manufacture of API under Part 211. It has been elaborately discussed in the Code of Federal Regulations.我们将仔细检查次节的内容。更多信息请参阅21 CFR第210 & 211部分。We will just go through the contents of Subparts. For further information refer the Title 21 Code of Federal Regulations Parts 210 & 211. A. 介绍Introduction B. 组织和人员Organization and Personnel质量控制单元的责任Responsibilities of the Quality Control Unit人员确认Personnel Qualifications人员责任Personnel Responsibilities咨询者Consultants,管理看法Regulatory Perspective,C. 建筑物和设施Building and Facilities设计和建造特点Design and Construction Features照明Lighting 通风，空气过滤，空气加热，冷却Ventilation, Air Filtration, Air Heating, Cooling蒸汽，气体，和其他公用工程Steam, gases, and other Utilities管道设备，清洗和盥洗室设施Plumbing, Washing and Toilet Facilities污水和重复使用Sewage and Reuse卫生设施Sanitation维修MaintenanceD. 工艺设备Process Equipment设备设计，尺寸和就位Equipment Design, Size and Location设备建造和安装Equipment Construction and Installation设备清洁和维修程序Equipment Cleaning and Maintenance Procedures设备清洁方法Equipment Cleaning Methods设备清洁方法的验证Validation of Equipment Cleaning Methods在位清洁方法Clean in Place Methods自动，机械，电气和计算机设备,
