中国食品药品监管Issue(11)：44-59,16.DOI:10.3969/j.issn.1673-5390.2023.11.006
关于山东省药品生产企业对连续制造生产模式的认知、开发意愿和监管考虑的调研分析
Investigation and Analysis on the Awareness,Development Intent,and Regulatory Considerations of Pharmaceutical Production Enterprises in Shandong Province Regarding Continuous Manufacturing Production Mode
摘要
Abstract
Objective:Aims to provide recommendations for the supervision of continuous manufacturing of pharmaceuticals by investigating the awareness,development intent,and regulatory considerations of key personnel in pharmaceutical production enterprises in Shandong Province.Methods:Data entry and statistical analysis were performed using SPSS 18.0,GraphPad,and Excel software.Results:A questionnaire survey was conducted online with 334 valid responses.Respondents represented a wide range of product types,covering active pharmaceutical ingredients,chemical drugs,traditional Chinese medicine,and biological products.While 46.41%subjectively claimed that they understood the ICH Q13 guideline,only 26.05%demonstrated objective comprehension.76.95%of the persons in charge expressed the intention to develop continuous manufacturing,and 79.34%intended to use process analytical technology,with 72.15%having the intention to purse both.Therefore,it can be seen that key personnel in pharmaceutical production enterprises in Shandong Province have a high intention to adopt continuous manufacturing production mode.Regarding supervision work related to continuous manufacturing production mode,the respondents prioritized evaluation,inspection,and the release of relevant policies,regulations,and guidelines.Conclusion:Based on the overall analysis of the questionnaire results,the following five aspects need to be addressed for the development and supervision of continuous manufacturing production:strengthen the promotion and implementation of ICH Q13 guideline;promptly issue guidance documents related to continuous pharmaceutical manufacturing;enhance the training of regulatory and technical personnel related to continuous manufacturing production;strengthen regulatory incentives throughout the pharmaceutical product lifecycle;and advance dedicated pilot initiatives or share relevant case studies to promote continuous pharmaceutical manufacturing.关键词
连续制造生产模式/山东省药品生产企业/ICH Q13/过程分析技术/监管考虑Key words
continuous manufacturing production mode/pharmaceutical production enterprises in Shandong Province/ICH Q13/process analytical technology/regulatory consideration分类
药学引用本文复制引用
孙钟毓,林泊然,胡敬峰,旺茂才吉,林兆媛,吴一波,肖杰,臧恒昌..关于山东省药品生产企业对连续制造生产模式的认知、开发意愿和监管考虑的调研分析[J].中国食品药品监管,2023,(11):44-59,16.基金项目
教育部首批新文科研究与改革实践项目(2021100056) （2021100056）
山东省重点研发计划软科学项目(2022RKY01007) （2022RKY01007）
