美国食品药品管理局(FDA)已以指导文件的方式向制药工业发出通知,支持将过程分析技术(PAT)作为现行生产质量管理规范(cGMP)的开创性组成部分。FDA指出,质量不是在产品中检验出来的,而是在过程中形成的,或者是由过程设计决定的。为此,FDA决定通过更好地了解和控制生产过程实施管理监督。 The US Food and Drug Administration (FDA) has issued guidance to the pharmaceutical industry in the form of a guidance document that supports the introduction of Process Analysis Technology (PAT) as a ground-breaking component of the current Production Quality Management Code (cGMP). The FDA notes that quality is not detected in the product but is formed in the process or determined by the process design. To this end, the FDA decided to implement regulatory oversight by better understanding and controlling the production process.