美国ANDA片剂(IR)开发模板 2(中英文对照).pdfVIP

Example QbD IR Tablet Module 3 Quality 3.2.P.2 Pharmaceutical Development IR 片剂 QbD 实例模块 3 质量 3.2.P.2 药物开发 2.3 Manufacturing Process Development 生产工艺的开发 Note to Reader: There are various approaches to process development used in the generic pharmaceutical industry. This is one of many possible examples. All QbD approaches to process development should identify the critical material attributes (CMAs) and critical process parameters (CPPs) for each process step. A firm may choose to do this through reference to documented prior knowledge or through empirical experiments on a range of process scales building toward the exhibit scale and proposed commercial scale. The process development of pre-roller compaction blending and lubrication is an example of experimentally determining CPPs when there is variation in an input material attribute. QbD emphasizes building understanding to avert failures during scale-up. The multivariate experiments described here are a step toward defining acceptable ranges for CPPs and CMAs. 致读者：仿制药行业中使用的工艺开发有多种方法。这是多种可能实例中的一种。工艺开发 的所有QbD方法应确定每个工艺步骤的关键物料属性(CMAs)和关键工艺参数(CPPs)。公司 可选择通过参考记录的先前知识或通过工艺规模范围内建立申报规模和拟定工业规模的实 证实验来进行。预碾压混合和润滑工艺的开发是当输入物料属性发生变化时，通过实验确定 CPPs的例子。QbD强调放大期间应建立理解以避免失败。此处描述的多元实验是迈向定义 CPPs和CMAs可接受范围的一步。 Steps to establish process understanding are as follows: 建立工艺理解的步骤如下： Identify all possible known material attributes and process parameters that could impact the performance of the process. 确定所有可能可影响工艺性能的已知物质属性和工艺参数。 Use risk assessment and scientific knowledge to identify potentially high risk attributes and/or parameters. 使用风险评估和科学知识以确定潜在的高风险属性和/或参数。 Identify levels or ranges of these potentially high risk attributes and/or parameters. 确定这些潜在的高风险属性和/或参数的水平或范围。 Design and conduct experiments, using DOE when appropriate. 如适用，使用DOE进行设计并进行实验。 Analyze the experimental data to deter