Topical Products and Critical Quality Attributes

专题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。 具有或不具有相同成分的产品之间的微观结构差异可能是 通过评估产品的某些关键质量属性进行调查。关键品质 属性也会影响产品在体内的性能。因此，有必要建立一个系统的 调查以了解潜在的故障模式、原因、质量属性 在确定产品性能和制造过程变量方面至关重要。从 从监管角度来看，产品之间可能存在第三季度的差异，即使 产品相当于第一季度和第二季度。 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，我们建议根据外用制剂的性质和组成对其进行分类。 确定每个类别的潜在故障模式，并确定符合以下条件的质量属性 对确定产品在体内的性能至关重要。找出最合适的方法 测量外用产品的物理和化学性质也是目标之一。 在AIM2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 针对每一类产品采用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.