World Health Organization guidelines on transfer of analytical methods of quality control for medical preparation

M. A. Razborova
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Abstract

This review contains the recommendations of the World Health Organization 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 World Health Organization guidelines on transfer of technology in pharmaceutical manufacturing. The recommendations are presented both for the transfer of medical preparation manufacturing and transfer of analytical methods for quality control for a medical preparation. This review contains the recommendations for the transfer of analytical methods only.
世界卫生组织关于转让医药制剂质量控制分析方法的准则
本审查载有世界卫生组织关于转让医药制剂质量控制分析方法的建议。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。充分描述制药技术转让过程的主要文件之一是世界卫生组织关于制药技术转让的准则。提出了关于药物制剂生产转移和药物制剂质量控制分析方法转移的建议。本审查仅包含对分析方法转移的建议。
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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