工艺验证
过程(计算)
计算机科学
产品(数学)
新产品开发
制造工程
质量(理念)
制造工艺
工艺工程
工程类
业务
材料科学
数学
认识论
操作系统
几何学
哲学
复合材料
营销
作者
T Sriranga.,Naveen Banakar,Vaishakha Kori,Chetankumar Vasanad
出处
期刊:Journal of Biomedical and Pharmaceutical Research
[CAB PUBLISHER]
日期:2021-10-18
卷期号:10 (5)
标识
DOI:10.32553/jbpr.v10i5.883
摘要
As per GMP process validation is very important and required part in product development. Process Validation is required for ensuring and providing the documentary evidence and also required for giving the Surety that process by which the formulation is prepared is capable of consistently producing the product of required quality and purity.
A validated manufacturing process is one which has been proved to do what it purports on is represented to do. The proof of validation is obtained through the collection and evaluation of data, preferably, beginning from the process development phase and Continuing through the production phase. Validation necessarily includes process qualification (the qualification of materials, equipment Systems, buildings, personnel), but it also includes the control on the entire process for repeated batches or runs. This article gives a general introduction and overview about process validation in pharmaceutical manufacturing process and its importance.
Keywords: GMP, Validation, validation manufacturing process.
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