摘要
目的 汇总分析药品生命周期变更管理中需要重点关注的问题,提高药品生产工艺变更过程中的变更管理水平。方法 以注射剂变更灭菌工艺为例,采用实证分析方法,引入药品质量体系均衡概念,分析研究者在变更研究与变更管理中存在的问题。结果与结论 药品质量体系是处方组成、原辅料控制、生产工艺、药包材与质量控制五方面的均衡体系。工艺变更研究应遵循质量源于设计的理念和利用过程分析工具,充分考虑质量体系的均衡。变更管理需要对药品进行系统的管理。
Abstract
OBJECTIVE To analyze the key problems in the management of drug production process changes during the drug life cycle, thus to improve the management of pharmaceutical production process changes. METHODS Taking the change of injection sterilization process as an example, the issues in the study and management of process change were analyzed by employing empirical analysis METHODS and introducing the concept of equilibrium analysis of the pharmaceutical quality system. RESULTS AND CONCLUSION The pharmaceutical quality system is the equilibrium system of five aspects, including prescription composition, raw material control, production process, packaging and quality control. Process change research should follow the concept that quality comes from design, use process analytical technologies, and give full consideration to the quality system equilibrium. Process change management needs a systematic management of drugs.
关键词
药品 /
工艺变更管理 /
药品生命周期 /
药品质量体系
{{custom_keyword}} /
Key words
management /
drug production process /
drug life cycle /
pharmaceutical quality system
{{custom_keyword}} /
李森,张景辰.
基于药品质量体系的生产工艺变更管理[J]. 中国药学杂志, 2015, 50(16): 1462-1466 https://doi.org/10.11669/cpj.2015.16.023
Li Sen, Zhang Jing-chen.
Management of Drug Production Process Changes Based on Pharmaceutical Quality System[J]. Chinese Pharmaceutical Journal, 2015, 50(16): 1462-1466 https://doi.org/10.11669/cpj.2015.16.023
中图分类号：
R95
{{custom_clc.code}}
({{custom_clc.text}})
{{custom_sec.title}}
{{custom_sec.title}}
{{custom_sec.content}}
参考文献
[1] LIU Z D. Discussion of the deviation handling, CAPA and changes control and their application in quality control of drug manufacture in the new edition of GMP.Chin Pharm Aff(中国药事), 2012, 26(6): 646-649.
[2] Chinese Food and Drug Administration. Technical guidelines for the research on the change of chemical and pharmaceutical products(已上市化学药品变更研究的技术指导原则), 2008.
[3] YU L X. Pharmaceutical Quality by Design: Product and Process Development, Understanding Control. Pharm Res, 2008, 25(4): 781-791.
[4] ZHANG Z F. QbD concept in the design and research of generic drugs. Chin Pharm News(中国医药报), 2014-09-16.
[5] Chinese Food and Drug Administration. Basic technical requirements of chemical medicine injection (Trial Implementation)(化学药品注射剂基本技术要求(试行)) . 2008
[6] Chinese Food and Drug Administration. Technical guidelines for the research on the compatibility of chemical medicine injection and plastic packaging materials(Trial Implementation)(化学药品注射剂与塑料包装材料相容性研究技术指导原则(试行)) . 2012.
[7] Chinese Food and Drug Administration. Technical guidelines for the research on the compatibility of chemical medicine injection and pharmaceutical glass packaging container(Draft for Comment)(化学药品注射剂与药用玻璃包装容器相容性研究技术指导原则(征求意见稿)) . 2013.
[8] HINZ D C. Process analytical technologies in the pharmaceutical industry: The FDA′s PAT initiative, Anal Bioanal Chem, 2006, 384(5): 1036-1042.
[9] Chinese Food and Drug Administration. Guidelines for sterilization/aseptic process validation (Draft for Comment)(灭菌/无菌工艺验证指导原则(征求意见稿)), 2013.
[10] Chinese Food and Drug Administration,Guide for Drug Production and Validation(药品生产验证指南). Beijing:Chemical Industry Press, 2003: 239- 368.
[11] Ch. P (2010) vol Ⅱ (中国药典2010年版二部). 2010:Append IX XIX C.
[12] JIANG Y, ZHANG B Z. Pay attention to the physical and chemical properties of raw and accessory materials, and take the level of sterility assurance into account. Chin Pharm News(中国医药报), 2012-05-1.
{{custom_fnGroup.title_cn}}
脚注
{{custom_fn.content}}
基金
上海理工大学博士启动基金资助项目(1000308001)
{{custom_fund}}
PDF(683 KB)
