黑龙江科学
黑龍江科學
흑룡강과학
Helongjiang Science
2015年
2期
80-81
,共2页
GMP%GMP自检%GMP自检员%GMP自检后续活动
GMP%GMP自檢%GMP自檢員%GMP自檢後續活動
GMP%GMP자검%GMP자검원%GMP자검후속활동
GMP%GMP self-test%GMP self-test member%GMP self-test follow-up activities
GMP自检是指药品生产企业内部对药品生产实施GMP的检查,是企业执行GMP中的一项重要内容,也是日常生产质量管理工作中一项重要的质量活动,实质上就是对企业完善生产质量管理体系的自我检查。通过GMP自检,发现企业执行GMP时存在的质量风险,并通过实施纠正和预防措施,来进一步提高GMP执行的持续性、符合性、有效性,通过自检进行持续改进。
GMP自檢是指藥品生產企業內部對藥品生產實施GMP的檢查,是企業執行GMP中的一項重要內容,也是日常生產質量管理工作中一項重要的質量活動,實質上就是對企業完善生產質量管理體繫的自我檢查。通過GMP自檢,髮現企業執行GMP時存在的質量風險,併通過實施糾正和預防措施,來進一步提高GMP執行的持續性、符閤性、有效性,通過自檢進行持續改進。
GMP자검시지약품생산기업내부대약품생산실시GMP적검사,시기업집행GMP중적일항중요내용,야시일상생산질량관리공작중일항중요적질량활동,실질상취시대기업완선생산질량관리체계적자아검사。통과GMP자검,발현기업집행GMP시존재적질량풍험,병통과실시규정화예방조시,래진일보제고GMP집행적지속성、부합성、유효성,통과자검진행지속개진。
GMP pharmaceutical manufac turing self-test refers to the internal implementation of GMP for pharmaceutical production inspection, GMP is a business executive in an important part of daily production and quality management is an important quality in work activities, in essence, is for enterprises to improve production quality management system of self-examination. By GMP self-test, found that companies perform GMP quality risk exists, and through the implementation of corrective and preventive measures to further improve the sustainability of GMP execution, compliance, effectiveness, through a self-test for continuous improvement.