一个基于对质量标准理解的新的取样策略

A quality standard-based sampling strategy

作为生产控制的一部分,通常需对片剂生产的外观质量进行中控检查。本研究是针对片剂特定水平缺陷,通过研究其生产工艺过程能力以确定批的缺陷率(质量水平),并应用于产品批的放行标准。同时依据质量持续性管理的理念,制定取样计划用于持续性片剂外观质量水平评估和控制。

As a part of the manufacturing instructions, an in-process check is usually required to inspect the speciifc defects in tablets. A new sampling strategy based on the quality management concept was described. A quality level （batch defect rate） was established by the study of the capability of production process, which could be used as quality control metric. Meanwhile, an acceptance sampling plan was established based on the concept of continuous quality management so as to be applied to the assessment and control of continuously tablet visual quality.