制药过程偏差调查系统性工具及应用评价浅析

Analysis of Systematic Tools and Application Evaluation for Pharmaceutical Process Deviation Investigation

目的探讨制药企业在偏差调查工具、偏差调查系统有效性评价模型的应用。方法通过文献研究,综述偏差调查系统研究现状,结合工作实践,阐释如何应用偏差调查工具、偏差调查系统有效性评价模型来帮助企业构建和优化偏差调查系统。结果制药企业获得偏差调查系统构建和优化的思路。结论定期应用偏差调查系统有效性评价工具,识别改进项,构建有效的偏差调查系统,进一步保证药品的安全性、有效性和质量可控性。

Any deviation from the approved procedures(guidance documents)or established standards,such as production processes,mass balance limits,quality standards,inspection methods,operating procedures,etc.,should be documented and deviation investigations should be conducted.In the process of deviation investigation,the selection of reasonable investigation tools and correct application,and the regular evaluation of the effectiveness of the application of investigation tools,is conducive to the enterprise to build a good deviation investigation system,in line with the"Good Manufacturing Practice for Drugs(2010 Revision)"and other laws and regulations,to further improve the safety,effectiveness and quality controllability of drugs,to ensure the safety of the people.To explore the application of systematic tools and the effectiveness evaluation methods in the investigation of pharmaceutical process deviation in pharmaceutical companies.This paper analyzes and discusses the current situation of the deviation investigation system,the introduction of systematic tools and the effectiveness evaluation methods.Through literature research,the current research status of deviation investigation systems was summarized,and combined with work practice,explains how to promote the construction and optimization of deviation investigation systems for pharmaceutical companies from the perspective of the application of deviation systematic tools and their effectiveness evaluation.Pharmaceutical companies gain ideas for the application of deviation systematic tools and the construction and optimization of deviation investigation systems.Different pharmaceutical companies produce different varieties of drugs,face different markets and drug regulatory agencies,and different varieties,different markets,and different drug regulatory agencies may have different production and quality control requirements.The development history of pharmaceutical companies is different,the composition of different personnel,and the organizational structure are different,which creates different corporate cultures,and corporate culture affects the thinking habits and behaviors of personnel.The deviation investigation system tools and effectiveness evaluation methods between different pharmaceutical companies cannot be the same,as long as they are consistent with the characteristics of their respective products and processes,and are compatible with the improvement objectives of the quality management system,they are all acceptable and worthy of promotion.In addition,deviation investigation systems are not siloed,and the more complex the system,the more resources it may consume.The more complete the system,the less obvious the progress will be,and the higher the cost-effectiveness ratio after resource investment.The quality management system needs to be comprehensively evaluated,comprehensively developed,and put resources into the places where they are most needed and do the right thing.Finally,the improvement of the deviation investigation system cannot be done behind closed doors,but also needs to learn from each other's strengths and learn from the past.The best learning materials are the guidelines for the deviation investigation system issued by the drug regulatory authority,the training and sharing of the deviation investigation system organized by the organization,and the detailed information about the defects related to the deviation investigation system published.In conclusion,the effectiveness of their application is regularly evaluated by using systematic deviation investigation tools,which is conducive to building an effective deviation investigation system and further ensuring the safety,effectiveness and quality controllability of drugs.