| 薛晶,黄清泉,张洁.新修订的《生物制品批签发管理办法》对检验业务流程的影响及对策[J].中国药事,2021,35(8):871-876 |
| 新修订的《生物制品批签发管理办法》对检验业务流程的影响及对策 |
| Impact of the Newly-revised "Regulations for Lot Release of Biological Products" on Some Inspection Processes and Countermeasures |
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| DOI：10.16153/j.1002-7777.2021.08.004 |
| 中文关键词: 生物制品 批签发 管理办法 检验业务 流程 |
| 英文关键词: biological products lot release regulations inspection process |
| 基金项目: |
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| 中文摘要: |
| 目的：研究2021年3月1日实施的《生物制品批签发管理办法》(以下简称2020版办法)对部分非检验环节业务流程提出的新要求，为批签发机构相关人员在批签发工作中贯彻落实提供参考。方法：从流程管理的角度出发，对比2020版办法和同步废止的2017版《生物制品批签发管理办法》，分析二者的不同之处对部分业务流程可能带来的影响，并对今后的工作提出针对性的建议。结果：2020版办法对生物制品批签发的资料审核、样品受理、证书制发、复审、信息公开等流程提出了多项新要求，进一步规范了批签发管理工作。结论：新修订的《生物制品批签发管理办法》的发布和实施，对批签发工作提出了新的、更高的要求，相关人员应加强学习、尽快适应。 |
| 英文摘要: |
| Objective: To provide references for the relevant personnel of the batch issuing institutions to implement the batch issue work and study the new requirements for non-inspection links in the business process of the "Administrative Measures for the Batch Issue of Biological Products" implemented on March 1, 2021. Methods: From the perspective of process management, this paper compares the 2020 version of the method and the 2017 "Administrative Measures for the Batch Issue of Biological Products" of the synchronous abolition method, the possible impact of the differences between the two versions of regulations on some business processes was analyzed, and some targeted suggestions for future work were put forward. Results: The 2020 version of the measures puts forward a number of new requirements for the process of data audit, sample acceptance, certificate preparation and distribution, reviews, information disclosure and so on. Then the management of batch issuance of biological products was further standardized. Conclusion: According to the release and implementation of the newly-revised "Administrative Measures for the Batch Issuance of Biological Products", new and higher requirements for the batch issuance work were put forward. Relevant personnel should strengthen learning and adapt to the implemented regulation as soon as possible. |
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