对药品生产过程分析质量设计的综合认识综述。

Sai Prasad, Kolpana Diwekar, A Anite
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引用次数: 1

摘要

当基于纯科学理解和质量风险管理的知识应用于产品和工艺学习,并与过程控制法规以及系统的方法一起开发分析领域的预定义目标时,它被称为质量设计或QBD。它遵循ICH药品质量指南,QBD概念也扩展到分析方法,它是QBD中定义目标的强制性过程。该方法的协议将以系统的方式继续监控整个过程,并研究替代方法以获得最佳性能,给出的方法以结构化模式仔细分析风险,并对方法的有效性提出挑战,这些方法稍后可以作为这些研究的标准和益处。本文简要介绍了分析QBD在工业中的应用及其现状,包括HPTLC分析方法、水分滴定法、混合物中有毒杂质的测定方法的实例和原理。化学成分的定量颜色测定和各种光谱鉴定方法。QBD开发的光谱和色谱方法通常按照ICH Q8 R2完成,对关键参数进行原理对比观察和分析,HPTLC方法采用溶剂用量和检测吸光度和波长对比。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Review on comprehensive understanding of building an analytical quality by design for drug manufacturing process.
When knowledge based on pure scientific understanding and quality risk management is applied to product and process learning with regulation on process control along with a systematic approach for development of predefined objectives in analytical field then it is called as quality by design or QBD it follow ICH guidelines for quality in pharmaceutical product concept of QBD also extends to analytical methods, it is mandatory process in QBD to define a goal. A protocol for the method which will continue monitoring the process throughout in a systematic way and working on alternate methods as well to get optimal performance, the methods given are carefully analyzed in structured pattern for risks and is put for a challenge of the validity of method which later on can be taken for the criteria, benefit of these studies. The performances can be improved as well as clearly understood along with the risk management and desired performance methods which can also be validated later on, the review briefly gives an inside view of application of analytical QBD in industries and its current status with examples and principles of analytical methods in HPTLC ,titration for moisture content, determination of toxic impurities in mixtures, quantative colour measurement and various spectroscopic method for identification of chemical moiety. QBD developed spectroscopic and chromatographic method is usually done as per ICH Q8 R2, the critical parameters are compared to principle observation and analysis, the HPTLC method employs solvent usage and detection of absorbance and wavelength comparison.
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