国际制药工程学会医药制剂质量控制分析方法转移指南

Farmacevticheskoe delo i tehnologija lekarstv (Pharmacy and Pharmaceutical Technology) Pub Date : 2021-09-15 DOI:10.33920/med-13-2110-07

M. A. Razborova

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引用次数: 0

摘要

这篇综述包含了国际药物工程学会对药物制剂质量控制分析方法转移的建议。由于缺乏详细描述技术转让过程的俄罗斯文件，药品开发商和制造商应参考国际准则。国际制药工程学会关于制药技术转让的指导方针是全面描述制药技术转让过程的主要文件之一。本审查仅包含对分析方法转移的建议。国际制药工程学会也对医药制剂生产的转移提出了建议。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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International Society for Pharmaceutical Engineering guidelines on transfer of analytical methods of quality control for medical preparation

This review contains the recommendations of International Society for Pharmaceutical Engineering for the transfer of analytical methods of quality control for medical preparation. Due to the absence of the Russian documents describing in detail the technology transfer process, pharmaceutical developers and manufacturers should refer to international guidelines. One of the main documents which fully describes the process of pharmaceutical technologies transfer is International Society for Pharmaceutical Engineering guidelines on transfer of technology in pharmaceutical manufacturing. This review contains the recommendations for the transfer of analytical methods only. International Society for Pharmaceutical Engineering also have recommendations for the transfer of medical preparation manufacturing.

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Farmacevticheskoe delo i tehnologija lekarstv (Pharmacy and Pharmaceutical Technology)

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