医药工业从研发到生产的技术转移及其文件编制综述

V. Manikandan, K. Kathiresan
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引用次数: 0

摘要

在药物发现到药物产品开发的过程中,技术转让在制药工业中起着里程碑式的作用。技术转移从研发部门转移到生产部门,经过研究阶段、开发阶段和生产阶段,使产品进一步商业化的技术。本研究试图探讨技术转移的原因和重要性,技术转移的处理步骤,以及技术转移的文献报告。建立各种文件的确认技术,并在技术到达生产部之前由质保部进行检查和验收。因此,建议的转移技术将有助于通过文档报告中提到的过程开发产品。
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TECHNOLOGY TRANSFER FROM R & D TO PRODUCTION AND ITS DOCUMENTATION IN PHARMACEUTICAL INDUSTRY: A REVIEW
Technology transfer plays a milestone in the pharmaceutical industry during the citation of drug discovery to drug product development. Technology transfer technique transferred from Research & Development (R&D) department to production department through the process of the research phase, development phase, and production phase for further product commercialization. This study was an attempt to discuss the reasons and importance of technology transfer, processing steps for technology transfer, and its documentation report. Establishing confirmation technique for all kinds of documentation and will be inspected and accepted by quality assurance department before the technologies reaches the production department. Hence, the proposed transferring technique will help to develop the product through the processes mentioned in the documentation report.
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