药品验证技术综述

Darshan A. Salade, Kishor S. Arote, P. Patil, Vikas V. Patil, Amol R. Pawar
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引用次数: 0

摘要

验证是授权书面证据的程序,证明以下工艺将始终如一地生产导致预期结果的产品。根据GMP验证研究是GMP的重要组成部分,这些研究需要按照预定义的协议进行,至少应该验证的内容包括工艺,测试和清洁,因此建立控制程序以监控可能导致药品变异性的生产工艺的输出和验证。验证是实现和保持最终产品质量的重要环节之一。验证研究提供了公司所采用的检测方法的准确性、灵敏度、特异性和可重复性,应建立并形成文件。工艺验证是提高制药工业生产的剂型的安全性和质量的过程。根据cGMP,工艺验证是质量保证的一个组成部分。验证和质量保证将齐头并进,确保产品的全面质量。工艺验证在药品生产过程中起着关键作用,因为它提供了高度的保证和证据,证明正在实施的工艺给出了统一的结果,也就是说,它意味着要求的规范已经准确地执行了。本综述的目的是介绍和概述制药行业的验证。
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A Brief Review on Pharmaceutical Validation
Validation is the procedure which authorizing documentary evidence that proves the following process will consistently produce the product which leads to the expected result. According to GMP validation studies are important part of GMP these are required to be done as per predefined protocols, the minimum that should be validated include process, testing and cleaning as a result such control procedure stablish to monitor the output and validation of manufacturing processes that may be responsible for variability of drug product. Validation is the one of the important part in achieving and maintaining the quality of the final product. The validation study provides the accuracy, sensitivity, specificity and reproducibility of the test methods employed by the firms, shall be established and documented. Process validation is the process for improving the safety and quality of the dosage form which is manufactured in the pharmaceutical industry. Process validation is an integral part of quality assurance as per cGMP. Validation and quality assurance will go hand in hand, ensuring the thorough quality for product. Process validation plays a key role in the pharmaceutical manufacturing process as it delivers a high degree of assurance and evidence that the process, which is being carried out gives out the uniform results, that is, it means the required specifications, which has been performed accurately. The purpose of this review is to present an introduction and general review on validation in pharmaceutical industry.
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