关键质量属性
A Critical Quality Attribute (CQA) is a physical, chemical, biological, or microbiological property or characteristic that should be within an appropriate limit, range, or distribution to ensure the desired product quality. CQAs can be associated with drug substances, drug products, excipients, intermediates (in-process materials), and container/closure components. At an early stage of process development, the information available on product attributes may be limited. For this reason, the first set of CQAs may come from prior knowledge obtained during early development and/or from similar products rather than from extensive product characterization. The degree of criticality assigned to quality attributes is derived using risk-based tools and the potential impact of the attributes on safety and efficacy. Following comprehensive assessments of scientific evidence and risk, quality attributes are ranked according to the degree of criticality, which may be a continuum that more accurately reflects the complexity of structure-function relationships and varying levels of uncertainty around attribute classification. Attributes not assigned as CQAs should also be considered in the development of the process.
关键质量属性（CQA）是为了保证预期药品质量需要保持
在适宜的限度、范围或分布范围内
的物理的、化学的、生物的或微生物的性质或特性。CQAs 可能与原料药、制剂产品、辅料、中间产品（中间物料）和容器/密封系统有关。在工艺开发的早期可以限定为可用的产品属性信息。为此，起初设定的关键质量属性可能来自早期开发和/或类似产品获取的先前的知识而不是大量的产品性质。质量属性的关键程度来源于利用基于风险的工具和质量属性对安全性与有效性的潜在影响。在对科学证据和风险进行了综合评估之后，根据关键性程度对质量属性排序，这样可能更能反映结构-功能关系的复杂性和属性分类不确定性的变化程度。与CQAs 无关的属性在工艺开发中也应加以考虑。
CQAs are not synonymous with specifications. In addition, there is not necessarily a one-to-one relationship between CQAs and specifications. Specifications are a list of tests, references to analytical procedures, and appropriate acceptance criteria that are numerical limits, ranges, or other criteria for the tests described. Several product attributes identified as CQAs may be detected by a single test method, and therefore, built into a single test specification (e.g., API solubility, hardness, porosity are CQAs evaluated using a single test: dissolution). Some CQAs may not be included in the specifications if they are very well-controlled and consistently achieved within the process (e.g., viral clearance is not tested for every batch), while some attributes not considered critical may be included in the specifications.
CQAs 与质量标准不是同义词。另外，也没有必要将CQAs 与质量标准一一对应。质量标准是检验、参照的分析程序和用数值限度、范围描述的适当的可接受标准或描述的测试的其他标准的列表。被确定为CQAs 的几个产品属性可以用单一方法检查，因此，可以建立单一的测试标准（例如：API 的溶解度、硬度、孔隙度是可以用一个试验-溶出度来评价的CQAs）。有些在工艺过程中容易控制和达到的CQAs 可以不包含在质量标准中（如病毒清除不是每批检查），而一些不是关键性的属性也可能制定在质量标准中。
