上海医药
上海醫藥
상해의약
SHANGHAI MEDICAL & PHARMACEUTICAL JOURNAL
2015年
11期
57-60
,共4页
质量管理体系%体系有效性%制药企业
質量管理體繫%體繫有效性%製藥企業
질량관리체계%체계유효성%제약기업
quality management system%effectiveness of system%pharmaceutical enterprise
目的：为制药企业质量管理体系有效运行提供实践活动的思路和方法。方法：坚持质量体系运行的系统观和发展观，从体系运行基础、过程和结果三方面探讨提高质量管理有效性的措施。结果：制药企业应有与动态环境相适应的资源条件，显著的行为触发通知，落实高效的变更流程和谨慎的偏差调查流程，执行有效的激励机制和持续的内审机制。结论：只有坚持系统观点、发展观点，企业的质量管理体系才能得到有效执行和持续改进。
目的：為製藥企業質量管理體繫有效運行提供實踐活動的思路和方法。方法：堅持質量體繫運行的繫統觀和髮展觀，從體繫運行基礎、過程和結果三方麵探討提高質量管理有效性的措施。結果：製藥企業應有與動態環境相適應的資源條件，顯著的行為觸髮通知，落實高效的變更流程和謹慎的偏差調查流程，執行有效的激勵機製和持續的內審機製。結論：隻有堅持繫統觀點、髮展觀點，企業的質量管理體繫纔能得到有效執行和持續改進。
목적：위제약기업질량관리체계유효운행제공실천활동적사로화방법。방법：견지질량체계운행적계통관화발전관，종체계운행기출、과정화결과삼방면탐토제고질량관리유효성적조시。결과：제약기업응유여동태배경상괄응적자원조건，현저적행위촉발통지，락실고효적변경류정화근신적편차조사류정，집행유효적격려궤제화지속적내심궤제。결론：지유견지계통관점、발전관점，기업적질량관리체계재능득도유효집행화지속개진。
Objective: To provide ideas and methods for the pharmaceutical enterprises to efficiently run quality management system.Methods: The measures for the improvement of the effectiveness of quality management were discussed by three aspects including the way of foundation, the process and results adhering to the point of system and development.Results:Pharmaceutical enterprises should adhere to the point that requires lfexible resource conditions, signiifcant trigger notiifcation, effective change and deviation control, effective incentive mechanism and the ongoing internal audit mechanism.Conclusion:The quality management system can be effectively implemented and continuously improved only by upholding the points of view of the system and the development .
