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首页> 外文期刊>Research journal of pharmacy and technology >Quality by design: A new Era of development of quality in pharmaceuticals
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Quality by design: A new Era of development of quality in pharmaceuticals

机译：通过设计实现质量：药物质量发展的新时代

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摘要

Quality by design (QbD) is an essential part of the modern approach to pharmaceutical quality. The purpose of this article is to discuss the concept of Quality by Design and describe how it can help to ensure pharmaceutical quality. QbD has to assist both industry and FDA to move towards a more scientific, risk based, holistic and proactive approach to pharmaceutical development. QbD uses a systematic approach to ensure quality by developing a thorough understanding of the compatibility of a finished product to all of the components and processes involved in manufacturing that product. Instead of relying on finished product testing alone, QbD provides insights upstream throughout the development process. Under this concept of QbD throughout designing and development of a product, it is essential to define desire product performance profile i.e. Quality Target Product Profile (QTPP) and identify Critical Quality Attributes (CQA). On the basis of this we can design the product formulation and process to meet the product attributes. This leads to recognise the impact of raw materials [Critical Material Attributes (CMA)], Critical Process Parameters (CPP) on the CQAs and identification and control sources of variability. Implementation of QbD is enabling transformation of the chemistry, manufacturing, and controls (CMC) review of Abbreviated New Drug Applications (ANDAs) into a modern, science and risk based pharmaceutical quality assessment.
机译：设计质量（QbD）是现代药物质量方法的重要组成部分。本文的目的是讨论“设计质量”的概念，并描述其如何有助于确保药物质量。 QbD必须协助工业界和FDA朝着更加科学，基于风险，整体和主动的药物开发方法迈进。 QbD使用系统的方法，通过对成品与制造该产品所涉及的所有组件和过程的兼容性有透彻的了解来确保质量。 QbD不再仅依赖成品测试，而是在整个开发过程中向上游提供见解。在整个产品设计和开发过程中，都遵循QbD的概念，定义所需的产品性能概况，即质量目标产品概况（QTPP）和识别关键质量属性（CQA），至关重要。在此基础上，我们可以设计满足产品属性的产品配方和工艺。这样就可以认识到原材料的影响[关键材料属性（CMA），关键过程参数（CPP）对CQA的影响以及可变性的识别和控制来源。 QbD的实施使化学，制造和控制（CMC）对“简明新药申请（ANDA）”的审查转变为现代的，基于科学和风险的药物质量评估。

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