Topical Products and Critical Quality Attributes

外用产品及其关键质量属性 摘要 局部产品的微观结构受制造工艺变量的影响很大。 具有或不具有相同组成的产品之间的微观结构差异可能是 通过评价产品的某些关键质量属性进行研究。关键质量 属性也影响产品在体内的性能。因此，需要有系统的 调查以了解潜在的失效模式、原因、 在确定产品性能和制造工艺变量方面至关重要。从 从监管的角度来看，第三季度的差异可能存在的产品，即使当 产品Q1和Q2等同。 我们在这个项目中提出了两个具体目标，以解决上述讨论的领域。 在目标1中，我们建议根据其性质和组成对局部制剂进行分类。 识别每个类别的潜在失效模式，并识别 在体内决定产品性能的关键。找出最合适的方法 用于测量局部产品的物理和化学性质也是目标之一。 在aim 2中，我们建议调查过程变量对关键质量属性的影响。 （CQA）和产品的性能属性。我们还建议建立设计空间 对于每一类产品，使用QbD方法。

Topical Products and their Critical Quality Attributes ABSTRACT The microstructure in topical products is highly influenced by the manufacturing process variables. The microstructural differences between products with or without same composition could be investigated by evaluating certain critical quality attributes of the product. The critical quality attributes also influence the product performance in vivo. Therefore, there is need for a systematic investigation to understand the potential failure modes, the reasons, the quality attributes that are critical in determining the product performance and manufacturing process variables. From the regulatory perspective, Q3 difference could possibly exist between the products even when the products are Q1 and Q2 equivalent. We propose two specific aims in this project to address the above discussed areas. In aim 1 we propose to classify the topical formulations based on their nature and composition. To identify the potential failure modes for each class and to identify the quality attributes that are critical in determining the product performance in vivo. To identify the most appropriate methods for measuring the physical and chemical properties of the topical product is also one of the goals. In aim2 we propose to investigate the effect of process variables on the critical quality attributes (CQAs) and the performance attributes of the product. We also propose to establish design space for each class of the products using QbD approach.