文章摘要
徐晓宏,孙利民,韩云川,田洁.药品生产过程中中间产品/待包装产品存放时限的技术要求及审评考虑[J].中国药事,2022,36(12):1343-1349
药品生产过程中中间产品/待包装产品存放时限的技术要求及审评考虑
Technical Requirements and Review Considerations for Holding Times of the Intermediate Products/ Bulk Products in the Pharmaceutical Production Process
  
DOI:10.16153/j.1002-7777.2022.12.002
中文关键词: 中间产品  待包装产品  存放时限  口服固体制剂  过程控制
英文关键词: intermediate products  bulk products  holding times  oral solid dosage forms  process control
基金项目:
作者单位
徐晓宏 国家药品监督管理局药品审评中心,北京 100022 
孙利民 山东省食品药品审评查验中心,济南 250014 
韩云川 国家药品监督管理局药品审评中心,北京 100022 
田洁 国家药品监督管理局药品审评中心,北京 100022 
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中文摘要:
      目的:通过讨论中间产品/待包装产品存放时限的重要意义、法规要求及研究中需考虑的内容, 以期为药品生产过程中中间产品/待包装产品存放时限研究提供指导和参考。方法:主要梳理了国外相关指南和当前国内审评技术要求,结合日常药学审评工作,以口服固体包衣片为例对中间产品/待包装产品存放时限的研究内容进行了讨论。结果结论:无论从GMP角度还是审评角度,在非连续生产中(尤其需要特殊贮存的产品),中间产品/待包装产品存放时限的研究均需引起研究者的足够关注,应结合各监管机构相关指南、当前国内审评技术要求以及产品特点,对中间产品/待包装产品进行考察,以保证终产品符合质量标准。
英文摘要:
      Objective: In order to provide guidance and references for the study on holding times of the intermediate products/bulk products in the pharmaceutical production process, the significance, regulatory requirements, and the contents to be considered in the research were discussed. Methods: The relevant foreign guidelines and the current domestic technical review requirements were reviewed, combined with the daily pharmaceutical review work, the research content of holding times of the intermediate products/bulk products were discussed by taking solid oral coated tablets as an example. Results and Conclusion: Whether from the perspective of GMP or review, in the non-continuous production (especially for products requiring special storage), the research on holding times of the intermediate products/bulk products should attract enough attention from researchers, and the intermediate products/bulk products should be investigated in combination with the relevant domestic and foreign guidelines, the current domestic technical review requirements and product characteristics so as to ensure that the fi nal products meet the specifi cations.
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