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【转载】ICH Q8 (CH&EN) 2  

2012-11-27 16:06:19|  分类: 生物医药产业 |  标签: |举报 |字号 订阅

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本文转载自Julia《ICH Q8 (CH&EN) 2》

2. PHARMACEUTICAL DEVELOPMENT 药物开发

The aim of pharmaceutical development is to design a quality product and its manufacturing process to consistently deliver the intended performance of the product. The information and knowledge gained from pharmaceutical development studies and manufacturing experience provide scientific understanding to support the establishment of the design space, specifications, and manufacturing controls.   药物开发的目的在于设计符合质量要求的产品及符合重复生产模式的制造工艺。在药物开发和研究过程中所获得的信息和知识将为建立质量标准和生产控制提供科学的依据。

Information from pharmaceutical development studies can be a basis for quality risk management. It is important to recognize that quality cannot be tested into products; i.e., quality should be built in by design. Changes in formulation and manufacturing processes during development and lifecycle management should be looked upon as opportunities to gain additional knowledge and further support establishment of the design space. Similarly, inclusion of relevant knowledge gained from experiments giving unexpected results can also be useful. Design space is proposed by the applicant and is subject to regulatory assessment and approval. Working within the design space is not considered as a change. Movement out of the design space is considered to be a change and would normally initiate a regulatory post approval change process. 药物开发研究过程中所获得的信息是风险评估的基础。质量是通过设计建立起来的,而不是通过对产品的检测得来的,认识这一点是很重要的。开发过程中的配方和生产工艺的变更应当被看成是获得更多额外知识的机会,以进一步支持设计空间的建立。包括从失败实验中获得的知识也是有用的,也可以用于支持所选择的产品及其生产工艺。

The Pharmaceutical Development section should describe the knowledge that establishes that the type of dosage form selected and the formulation proposed are suitable for the intended use. This section should include sufficient information in each part to provide an understanding of the development of the drug product and its manufacturing process. Summary tables and graphs are encouraged where they add clarity and facilitate review. 药物开发一章应当阐述为满足申请中所规定的目的,建立所选择的剂型和拟定的配方的知识基础。在本章节中的每一个部分都应当要包括足够的资料用以理解制剂及其生产工艺的开发。鼓励使用表格和图表进行概述。At a minimum, those aspects of drug substances, excipients, container closure systems, and manufacturing processes that are critical to product quality should be determined and control strategies justified. Critical formulation attributes and process parameters are generally identified through an assessment of the extent to which their variation can have impact on the quality of the drug product. 至少,应当要对关键的且能很大程度上影响产品质量的方面进行确定和讨论,它们包括原料药,赋形剂和生产工艺,这些方面也是需要检测和控制的。通过评估它们的变化程度对制剂质量的影响可确定这些关键的配方属性和工艺参数。

In addition, the applicant can choose to conduct pharmaceutical development studies that can lead to an enhanced knowledge of product performance over a wider range of material attributes, processing options and process parameters. Inclusion of this additional information in this section provides an opportunity to demonstrate a higher degree of understanding of material attributes, manufacturing processes and their controls. This scientific understanding facilitates establishment of an expanded design space. In these situations, opportunities exist to develop more flexible regulatory approaches, for example, to facilitate: 此外,申请者也可以选择进行一些其它的药物开发研究以在更广的物料属性范围,操作选项范围和工艺参数范围内对产品的性能有更深的了解。将这些更多的信息包括在本章节使得可以对生产工艺和过程控制有更高的理解。这样的科学理解确立了设计空间。这些情况为建立更灵活的药政管理办法提供了可能,比如,便于:

·         risk-based regulatory decisions (reviews and inspections); 基于风险管理的药政决议(审核和现场检查);

·         manufacturing process improvements, within the approved design space described in the dossier, without further regulatory review; 生产工艺改进,在文件所述的已批准的设计空间范围内,不需要进一步的药政审核;

·         reduction of post-approval submissions; 减少预审批呈递

·         real-time quality control, leading to a reduction of end-product release testing. “实时”质量控制,导致最终产品的放行检测的减少

To realise this flexibility, the applicant should demonstrate an enhanced knowledge of product performance over a range of material attributes, manufacturing process options and process parameters. This understanding can be gained by application of, for example, formal experimental designs, process analytical technology (PAT), and/or prior knowledge. Appropriate use of quality risk management principles can be helpful in prioritising the additional pharmaceutical development studies to collect such knowledge. 为了实现这种灵活性,申请者应当要在物性(如:粒径分布、水分、流动性),操作选项和工艺参数等的某一范围内对产品性能进行更高层次的论述。可以通过实行规范的实验设计或工艺分析技术(PAT)来获得这些知识。适当地应用风险管理原则,有助于按其优先性进行排序额外的药物开发研究,以获得这些知识。The design and conduct of pharmaceutical development studies should be consistent with their intended scientific purpose. It should be recognized that the level of knowledge gained, and not the volume of data, provides the basis for science-based submissions and their regulatory evaluation. 药物开发研究的设计和实施应当要和其拟定的科学目的和产品开发阶段相一致。需要认识到的是所获知识的层次,而不是数据量,为科学的申请文件及其药政评审提供了基础。

 

 

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