用于药品工业生产的工艺、设备和系统的验证活动

Igor Valerievich Korobkin
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引用次数: 0

摘要

成品的质量必须在生产过程之前确定。似乎有必要确保成品药品不仅符合监管条件,而且每次发布时都按照相同的程序和相同的条件生产。验证,作为GMP规则的一部分,描述了对给定过程的控制。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Activities for the validation of processes, qualification of equipment and systems used in the industrial manufacture of medicines
The quality of the finished product must be laid down before the production process. It seems relevant to create guarantees that the finished medicinal product not only meets regulatory conditions, but is also manufactured in accordance with the same procedure and under the same conditions every time it is released. Validation, as a section of the GMP rules, describes the control of a given process.
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