药品审评检查机构质量管理体系建设实践探索

目的:贯彻国务院强化质量管理、落实全国药监部门完善自身质量管理体系工作部署,梳理山东省药品审评检查机构质量管理体系建设情况,总结经验、查找不足,加强审评检查质量管理。方法:调研药品审评检查机构导入质量管理体系的现实意义,剖析山东省药品审评检查机构质量管理体系建设的实践经验,思考存在的问题。结果:行之有效的质量管理体系对药品审评检查机构规范化建设和药品审评检查发展起到了积极的推动作用。结论:药品审评检查机构推进质量管理体系建设,对规范自身建设、提高工作质量、降低业务风险、服务医药产业发展具有重要作用,也是必然要求,药品审评检查机构质量管理体系需要持续改进,逐渐与国际接轨。     

新旧化妆品检验规范的对比及对化妆品审评的影响

目的： 全面解读2019年9月10日国家药品监督管理局发布的《化妆品注册和备案检验工作规范》，为开展化妆品审评提供参考。方法： 从多个方面对比已实施的《化妆品注册和备案检验工作规范》和同步废止的《化妆品行政许可检验规范》，分析二者的不同之处对化妆品审评可能带来的影响，并对今后的工作方向提出预见和建议。结果： 《化妆品注册和备案检验工作规范》取消了现行的由药品监管部门对化妆品注册和备案检验检测机构进行资格认定和指定，允许社会优质资源承担化妆品注册和备案检验工作，并对检验工作流程进行了优化，对检验项目要求进行了调整和规范。结论： 《化妆品注册和备案检验工作规范》的发布和实施，对化妆品注册和备案检验以及化妆品审评工作都提出了新的要求，相关部门应尽快适应。     

刍议医院纪检监察在医院建设中的作用和实施

随着社会经济的快速发展,国内医疗事业的竞争日益激烈,医疗机构需要积极提高自身的业务水平和管理水平,才能强化医疗技术水平,获得更多的社会经济效益。在国内医疗体制深化变革的趋势下,纪检监察在医院建设中发挥着越来越重要的作用,主要职责是管理和监督医院各项制度的落实、健康环境的建设等,旨在规范机构医疗服务,提高机构服务质量,促使医院树立良好的社会形象,保障医院的社会经济效益。该文针对医院纪检监察在医院建设中的作用和实施展开分析。     

2018年广东省药品批发企业及零售连锁企业总部GSP飞行检查缺陷分析

该研究对55家药品批发企业及零售连锁企业总部在GSP飞行检查过程中发现的缺陷项目进行统计,分析存在问题。结果显示企业执行GSP工作较好,但质量管理体系、机构和质量管理职责、人员与培训、设施与设备、校准与验证等环节存在问题依然较为集中,可以采用风险管理的思维加强质量管理工作。     

Impact of visual inspection and radiographs for caries detection in children through a 2-year randomized clinical trial: The Caries Detection in Children–1 study

BackgroundVisual inspection (VIS) with radiographic examination (RAD) is the recommended diagnostic strategy for detecting caries in children; however, this recommendation is based on accuracy studies. The authors conducted a clinical trial to compare the detection and subsequent treatment of carious lesions in primary molars performed with VIS alone and with RAD.MethodsChildren (3-6 years old) were randomly assigned to 2 groups according to the diagnostic strategy used for caries detection on primary molars: VIS or RAD. Participants were diagnosed and treated according to the management plan related to the allocated group. The primary outcome was the number of new operative interventions during the 2-year follow-up period. Other secondary outcomes were also compared. Comparisons were performed with Mann-Whitney test using an intention-to-treat approach.ResultsOf the 252 children included and randomized, 216 were followed-up after 2 years (14.3% attrition rate). There was no difference between the groups for the primary outcome (P = .476). For the secondary outcomes, the RAD group had more restoration replacements (P = .038) and more restorations performed since the beginning of the study (P = .038) compared with the VIS group. In addition, the RAD group had a higher number of false-positive results than the VIS group (P < .001).ConclusionsSimultaneous use of VIS and RAD for caries diagnosis in primary molars of children who seek dental treatment does not provide additional benefits compared with VIS alone.Practical ImplicationsDentists should perform VIS only, not RAD, for detecting carious lesions in preschool-aged children.ClinicalTrials.gov: NCT02078453.     

The need for new control strategies for particulate matter in parenterals

An undesirable characteristic in lyophilized parenteral products is the potential presence of particulate matter in the final product, which may affect patient safety. In this study, quality risk management tools described in the International Conference on Harmonization Guideline Q9 were used to estimate the risks for a pharmaceutical manufacturing line, based on three critical quality attributes: (1) visible particulate matter; (2) lyo-cake collapse traces; and (3) lyo-cake melt-back traces. Together with a Process Failure Mode Effect Analysis (PFMEA), an input-output analysis of the individual unit operations identified seven major material classes of extrinsic particulate matter. In addition to the process assessment, an experimental investigation of the location of impurities in lyophilized products was performed. To that end, intentionally contaminated vials were examined to locate the particulate matter and its possible migration. The results emphasize the importance of a full transmission mode release testing since the particles may enter the interior of the lyo-cake. A theoretical explanation of the observed impurity locations is provided.     

诊断试剂应急检验工作机制建设探讨

目的： 通过新型冠状病毒诊断试剂应急检验工作，进一步改进和完善突发公共卫生事件应急检验管理体系建设，为检验检测机构积极开展应急检验工作提供借鉴。方法： 结合新型冠状病毒肺炎疫情中开展应急检验工作实践，梳理开展应急检验工作流程，探讨突发公共卫生事件的应急检验管理策略及措施。结果与结论： 实现应急检验制度化、规范化、程序化，通过合理的应急检验预案制定、应急检验组织架构的建立、应急物资的储备及保障、应急检验人员的培训等方面，构建应急检验管理体系，提高突发公共卫生事件应急检验的能力。建立完善的应急检验管理体系，可以提高应急检验工作效率，协调指导相关工作有序地进行，进一步提高应急检验管理水平。     

基于限定日剂量和帕累托图法分析某院2016年重点监控药品的使用情况

目的:了解重点监控药品管控成效,为进一步控制重点监控药品使用量提供参考。方法:参照2016年《四川省卫生和计划生育委员会关于建立医疗机构重点监控药品管理制度的通知》[1]所规定的重点监控药品制定某院重点监控药品目录,在对监控前后重点监控药品的销售金额进行回顾性分析的基础上,引入限定日剂量(DDD)的概念,采用DDD方法分析监控前后重点监控药品使用情况,并通过帕累托图分析法对实施重点监控后所监控药品进行分析,提示其中的主要影响品种。结果:经过对重点监控药品的专项整治,该院重点监控药品销量及DDDs下降有显著性,说明该院对重点监控药品的专项整治有效。实施监控后,重点监控药品销售金额的帕累托图分析显示在36个品规中14个品规构成主要因素。该院重点监控药品经整治后,主要影响重点监控药品销售金额的药品为兰索拉唑注射剂(17.84%),泮托拉唑注射制剂(16.49%),脑苷肌肽注射液(5.84%)。结论:临床药师对整治前后重点监控药品进行回顾性分析,重点监控药品使用情况改善有显著性,但具体分析后仍有不合理使用现象存在,应进一步优化管理。     

生化药品GMP附录实施情况的分析与探讨

目的：《药品生产质量管理规范》（2010年修订）生化药品附录的颁布和实施,对生化药品生产企业提出了新要求。本文对生化药品GMP附录的实施情况进行了分析,对如何进一步推进生化药附录的实施提出了建议。方法：通过对附录实施前后国内生化药品检查情况汇总分析,阐述部分生化药品生产企业还存在一些薄弱环节,建议从生化药品生产企业贯彻落实GMP附录和进一步加强生化药品生产监管工作两方面加以推进。结果与结论：生化药品生产企业的质量管理与生化药品附录的要求存在一定差距,尤其是在供应链管理方面。在药品监督检查中,必要时应进行延伸检查,从源头进行监管。