药品质量是指能够满足规定要求和需要的特征的总和。药品质量确立于研制阶段 ,形成于生产过程。但是 ,药品一旦产出 ,即在质量确定与质量形成得到保证的前提下 ,流通领域的质量保持与使用过程中的质量实现则依赖于质量抽查性检验予以控制。一般是通过抽取代表样本 ,依照既定质? Medicinal product quality is the sum of the characteristics that meet the specified requirements and needs. The quality of medicines is established in the development stage, formed in the production process. However, once the medicine is produced, that is, under the premise of quality assurance and formation of quality, the quality assurance in the circulation and quality control in the process of using depends on the quality check-up test. Usually by extracting representative samples, according to established quality?