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2021~2023年山东省保健食品生产许可现场核查情况分析及建议

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通过汇总分析2021~2023年山东省保健食品生产许可现场核查情况,发现缺陷项目分布较为集中、共性问题较多,缺陷项目占比较高的依次为设施设备、生产管理、品质管理、原辅料管理、库房管理等.主要原因可能是企业主体责任意识和风险管理意识不强、生产实际和质量体系管理存在脱节、培训内容与方式单一、人员专业性不强、履职能力不足、设施设备维护保养与资金投入不够等.建议相关企业强化主体责任意识、熟知法律法规、按章操作,加强培训的针对性,定期开展自查与风险排查,提升质量管理水平.审查部门应持续加强检查员队伍能力建设,确保检查的标准化、规范化、专业化.监管部门应创新监管方式,监督与指导企业开展自查和风险排查,压实企业主体责任.
Analysis and Suggestions on On-site Verification of Health Food Production License in Shandong Province from 2021 to 2023
By summarizing and analyzing the on-site verification of health food production license in Shandong Province from 2021 to 2023,it was found that defects were concentrated and consistent,with many common issues.Defective items accounted for a relatively high proportion in facilities and equipment,production management,quality management,raw material management,and warehouse management.The main reasons identified include weak awareness of corporate responsibility and risk management,a disconnect between production practices and quality system management,limited training content and methods,insufficient professionalism among personnel,inadequate capacity to fulfill duties,and insufficient maintenance and investment in facilities and equipment.It is suggested that enterprises strengthen their awareness of primary responsibility,familiarize themselves with laws and regulations,operate in compliance,enhance targeted training,conduct regular self-inspections and risk investigations,and improve quality management.Examination departments should continue to strengthen the capacity building of inspector teams to ensure standardized,professional,and regulated inspections.Regulatory authorities should innovate supervision methods,guide enterprises to conduct self-inspections and risk investigations,and consolidate corporate accountability.

health food production licenseon-site verificationdefect itemsproblem analysisquality improvement

赵明明、辛明、牛玲晓、陈洪忠、胡晓彤、王蕊

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山东省食品药品审评查验中心

保健食品生产许可 现场核查 缺陷项目 问题分析 质量提升

2024

中国食品药品监管
中国医药报社

中国食品药品监管

影响因子:0.099
ISSN:1673-5390
年,卷(期):2024.(11)