药品验证及其重要性和归算方法综述

M. Mohankumar, G. Sivakamasundari
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引用次数: 0

摘要

验证是实现和保持最后决定的特征的重要步骤。如果创意过程的每一个进展都得到认可,我们可以保证最终的结果将是最好的质量。验证是专门用于计划和预演与文档紧密计划的步骤。验证与质量保证密不可分,保证了产品的精心品质。过程验证强调了测量方案的组成部分,并在商业化期间坚持测量控制,并意识到它只不过是一个连续的程序,并根据项目生命周期调整测量验证练习。本调查背后的动机是介绍药品生产定量验证的介绍和一般披露,并对美国食品和药物管理局(FDA)规定的要求进行独特说明。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
A REVIEW ON PHARMACEUTICAL VALIDATION AND ITS IMPORTANCE AND IMPUTATION
Validation is a notable step in fulfilling and keep the character of the last decision. In the event that every progress of the creative process is recognized, we can guarantee that the end result will be of the best quality. Validation is specialized for planning and rehearsing a closely planned step with documents. Verification and quality assurance are inseparable, which guarantees careful quality of products. The process validation underscores the components of the measurement scheme and adheres to the measurement control during commercialization and realizes that it is nothing more than a continuous program and adjust the measurement validation exercises with the item life cycle. The motivation behind this survey is to introduce a presentation and general disclosure on quantitative validation of pharmaceutical production with a unique note to the requirements specified by the US Food and Drug Administration (FDA).
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