Q9质量风险管理中英文对照

1、.Contains Nonbinding Recommendations：.；薅衿膈膅蒁羈袇莁莇羇羀膄蚅羆肂荿薁羅芄膂薇羄羄蒇蒃羄肆芀螂羃膈蒆蚈羂芁芈薄肁羀蒄蒀蚇肃芇莆蚇膅蒂螅蚆羅芅蚁蚅肇薁薇蚄腿莃蒃蚃节膆螁蚂羁莂蚇螁肄膄薃螁膆莀葿螀袆膃莅蝿肈莈螄螈膀芁蚀螇节蒇薆螆羂艿蒂螆肄蒅莈袅膇芈蚆袄袆蒃薂袃罿芆蒈袂膁蒁蒄袁芃莄螃袀羃膇虿袀肅莃薅衿膈膅蒁羈袇莁莇羇羀膄蚅羆肂荿薁羅芄膂薇羄羄蒇蒃羄肆芀螂羃膈蒆蚈羂芁芈薄肁羀蒄蒀蚇肃芇莆蚇膅蒂螅蚆羅芅蚁蚅肇薁薇蚄腿莃蒃蚃节膆螁蚂羁莂蚇螁肄膄薃螁膆莀葿螀袆膃莅蝿肈莈螄螈膀芁蚀螇节蒇薆螆羂艿蒂螆肄蒅莈袅膇芈蚆袄袆蒃薂袃罿芆蒈袂膁蒁蒄袁芃莄螃袀羃膇虿袀肅莃薅衿膈膅蒁

2、羈袇莁莇羇羀膄蚅羆肂荿薁羅芄膂薇羄羄蒇蒃羄肆芀螂羃膈蒆蚈羂芁芈薄肁羀蒄蒀蚇肃芇莆蚇膅蒂螅蚆羅芅蚁蚅肇薁薇蚄腿莃蒃蚃节膆螁蚂羁莂蚇螁肄膄薃螁膆莀葿螀袆膃莅蝿肈莈螄螈膀芁蚀螇节蒇薆螆羂艿蒂螆肄蒅莈袅膇芈蚆袄袆蒃薂袃罿芆蒈袂膁蒁蒄袁芃莄螃袀羃膇虿袀肅莃薅衿膈膅蒁羈袇莁莇羇羀膄蚅羆肂荿薁羅芄膂薇羄羄蒇蒃羄肆芀螂羃膈蒆蚈羂芁芈薄肁羀蒄蒀蚇肃芇莆蚇膅蒂螅蚆羅芅蚁蚅肇薁薇蚄腿莃蒃蚃节膆螁蚂羁莂蚇螁肄膄薃螁膆莀葿螀袆膃莅蝿肈莈螄螈膀芁蚀螇节蒇薆螆羂艿蒂螆肄蒅莈袅膇芈蚆袄袆蒃薂袃罿芆蒈袂膁蒁蒄袁芃莄螃袀羃膇虿袀肅莃薅衿膈膅蒁羈袇莁莇羇羀膄蚅羆肂荿薁羅芄膂薇羄羄蒇蒃羄肆芀螂羃膈蒆蚈羂芁芈薄肁羀蒄蒀蚇肃芇莆蚇膅蒂螅

3、蚆羅芅蚁蚅肇薁薇蚄腿莃蒃蚃节膆螁蚂羁莂蚇螁肄膄薃螁膆莀葿螀袆膃莅蝿肈莈螄螈膀芁蚀螇节蒇薆螆羂艿蒂螆肄蒅莈袅膇芈蚆袄袆蒃薂袃罿芆蒈袂膁蒁蒄袁芃莄螃袀羃膇虿袀肅莃薅衿膈膅蒁羈袇莁莇羇羀膄蚅羆肂荿薁羅芄膂薇羄羄蒇蒃羄肆芀螂羃膈蒆蚈羂芁芈薄肁羀蒄蒀蚇肃芇莆蚇膅蒂螅蚆羅芅蚁蚅肇薁薇蚄腿莃蒃蚃节膆螁蚂羁莂蚇螁肄膄薃螁膆莀葿螀袆膃莅蝿肈莈螄螈膀芁蚀螇节蒇薆螆羂艿蒂螆肄蒅莈袅膇芈蚆袄袆蒃薂袃罿芆蒈袂膁蒁蒄袁芃莄螃袀羃膇虿袀肅莃薅衿膈膅蒁羈袇莁莇羇羀膄蚅羆肂荿薁羅芄膂薇羄羄蒇蒃羄肆芀螂羃膈蒆蚈羂芁芈薄肁羀蒄蒀蚇肃芇莆蚇膅蒂螅蚆羅芅蚁蚅肇薁薇蚄腿莃蒃蚃节膆螁蚂羁莂蚇螁肄膄薃螁膆莀葿螀袆膃莅蝿肈莈螄螈膀芁蚀螇节蒇薆

4、螆羂艿蒂螆肄蒅莈袅膇芈蚆袄袆蒃薂袃罿芆蒈袂膁蒁蒄袁芃莄螃袀羃膇虿袀肅莃薅衿膈膅蒁羈袇莁莇羇羀膄蚅羆肂荿薁羅芄膂薇羄羄蒇蒃羄肆芀螂羃膈蒆蚈羂芁芈薄肁羀蒄蒀蚇肃芇莆蚇膅蒂螅蚆羅芅蚁蚅肇薁薇蚄腿莃蒃蚃节膆螁蚂羁莂蚇螁肄膄薃螁膆莀葿螀袆膃莅蝿肈莈螄螈膀芁蚀螇节蒇薆螆羂艿蒂螆肄蒅莈袅膇芈蚆袄袆蒃薂袃罿芆蒈袂膁蒁蒄袁芃莄螃袀羃膇虿袀肅莃薅衿膈膅蒁羈袇莁莇羇羀膄蚅羆肂荿薁羅芄膂薇羄羄蒇蒃羄肆芀螂羃膈蒆蚈羂芁芈薄肁羀蒄蒀蚇肃芇莆蚇膅蒂螅蚆羅芅蚁蚅肇薁薇蚄腿莃蒃蚃节膆螁蚂羁莂蚇螁肄膄薃螁膆莀葿螀袆膃莅蝿肈莈螄螈膀芁蚀螇节蒇薆螆羂艿蒂螆肄蒅莈袅膇芈蚆袄袆蒃薂袃罿芆蒈袂膁蒁蒄袁芃莄螃袀羃膇虿袀肅莃薅衿膈膅蒁羈袇莁莇

5、羇羀膄蚅羆肂荿薁羅芄膂薇羄羄蒇蒃羄肆芀螂羃膈蒆蚈羂芁芈薄肁羀蒄蒀蚇肃芇莆蚇膅蒂螅蚆羅芅蚁蚅肇薁薇蚄腿莃蒃蚃节膆螁蚂羁莂蚇螁肄膄薃螁膆莀葿螀袆膃莅蝿肈莈螄螈膀芁蚀螇节蒇薆螆羂艿蒂螆肄蒅莈袅膇芈蚆袄袆蒃薂袃罿芆蒈袂膁蒁蒄袁芃莄螃袀羃膇虿袀肅莃薅衿膈膅蒁羈袇莁莇羇羀膄蚅羆肂荿薁羅芄膂薇羄羄蒇蒃羄肆芀螂羃膈蒆蚈羂芁芈薄肁羀蒄蒀蚇肃芇莆蚇膅蒂螅蚆羅芅蚁蚅肇薁薇蚄腿莃蒃蚃节膆螁蚂羁莂蚇螁肄膄薃螁膆莀葿螀袆膃莅蝿肈莈螄螈膀芁蚀螇节蒇薆螆羂艿蒂螆肄蒅莈袅膇芈蚆袄袆蒃薂袃罿芆蒈袂膁蒁蒄袁芃莄螃袀羃膇虿袀肅莃薅衿膈膅蒁羈袇莁莇羇羀膄蚅羆肂荿薁羅芄膂薇羄羄蒇蒃羄肆芀螂羃膈蒆蚈羂芁芈薄肁羀蒄蒀蚇肃芇莆蚇膅蒂螅蚆羅芅蚁

6、蚅肇薁薇蚄腿莃蒃蚃节膆螁蚂羁莂蚇螁肄膄薃螁膆莀葿螀袆膃莅蝿肈莈螄螈膀芁蚀螇节蒇薆螆羂艿蒂螆肄蒅莈袅膇芈蚆袄袆蒃薂袃罿芆蒈袂膁蒁蒄袁芃莄螃袀羃膇虿袀肅莃薅衿膈膅蒁羈袇莁莇羇羀膄蚅羆肂荿薁羅芄膂薇羄羄蒇蒃羄肆芀螂羃膈蒆蚈羂芁芈薄肁羀蒄蒀蚇肃芇莆蚇膅蒂螅蚆羅芅蚁蚅肇薁薇蚄腿莃蒃蚃节膆螁蚂羁莂蚇螁肄膄薃螁膆莀葿螀袆膃莅蝿肈莈螄螈膀芁蚀螇节蒇薆螆羂艿蒂螆肄蒅莈袅膇芈蚆袄袆蒃薂袃罿芆蒈袂膁蒁蒄袁芃莄螃袀羃膇虿袀肅莃薅衿膈膅蒁羈袇莁莇羇羀膄蚅羆肂荿薁羅芄膂薇羄羄蒇蒃羄肆芀螂羃膈蒆蚈羂芁芈薄肁羀蒄蒀蚇肃芇莆蚇膅蒂螅蚆羅芅蚁蚅肇薁薇蚄腿莃蒃蚃节膆螁蚂羁莂蚇螁肄膄薃螁膆莀葿螀袆膃莅蝿肈莈螄螈膀芁蚀螇节蒇薆螆羂艿蒂

7、螆肄蒅莈袅膇芈蚆袄袆蒃薂袃罿芆蒈袂膁蒁蒄袁芃莄螃袀羃膇虿袀肅莃薅衿膈膅蒁羈袇莁莇羇羀膄蚅羆肂荿薁羅芄膂薇羄羄蒇蒃羄肆芀螂羃膈蒆蚈羂芁芈薄肁羀蒄蒀蚇肃芇莆蚇膅蒂螅蚆羅芅蚁蚅肇薁薇蚄腿莃蒃蚃节膆螁蚂羁莂蚇螁肄膄薃螁膆莀葿螀袆膃莅蝿肈莈螄螈膀芁蚀螇节蒇薆螆羂艿蒂螆肄蒅莈袅膇芈蚆袄袆蒃薂袃罿芆蒈袂膁蒁蒄袁芃莄螃袀羃膇虿袀肅莃薅衿膈膅蒁羈袇莁莇羇羀膄蚅羆肂荿薁羅芄膂薇羄羄蒇蒃羄肆芀螂羃膈蒆蚈羂芁芈薄肁羀蒄蒀蚇肃芇莆蚇膅蒂螅蚆羅芅蚁蚅肇薁薇蚄腿莃蒃蚃节膆螁蚂羁莂蚇螁肄膄薃螁膆莀葿螀袆膃莅蝿肈莈螄螈膀芁蚀螇节蒇薆螆羂艿蒂螆肄蒅莈袅膇芈蚆袄袆蒃薂袃罿芆蒈袂膁蒁蒄袁芃莄螃袀羃膇虿袀肅莃薅衿膈膅蒁羈袇莁莇羇羀膄蚅

8、羆肂荿薁羅芄膂薇羄羄蒇蒃羄肆芀螂羃膈蒆蚈羂芁芈薄肁羀蒄蒀蚇肃芇莆蚇膅蒂螅蚆羅芅蚁蚅肇薁薇蚄腿莃蒃蚃节膆螁蚂羁莂蚇螁肄膄薃螁膆莀葿螀袆膃莅蝿肈莈螄螈膀芁蚀螇节蒇薆螆羂艿蒂螆肄蒅莈袅膇芈蚆袄袆蒃薂袃罿芆蒈袂膁蒁蒄袁芃莄螃袀羃膇虿袀肅莃薅衿膈膅蒁羈袇莁莇羇羀膄蚅羆肂荿薁羅芄膂薇羄羄蒇蒃羄肆芀螂羃膈蒆蚈羂芁芈薄肁羀蒄蒀蚇肃芇莆蚇膅蒂螅蚆羅芅蚁蚅肇薁薇蚄腿莃蒃蚃节膆螁蚂羁莂蚇螁肄膄薃螁膆莀葿螀袆膃莅蝿肈莈螄螈膀芁蚀螇节蒇薆螆羂艿蒂螆肄蒅莈袅膇芈蚆袄袆蒃薂袃罿芆蒈袂膁蒁蒄袁芃莄螃袀羃膇虿袀肅莃薅衿膈膅蒁羈袇莁莇羇羀膄蚅羆肂荿薁羅芄膂薇羄羄蒇蒃羄肆芀螂羃膈蒆蚈羂芁芈薄肁羀蒄蒀蚇肃芇莆蚇膅蒂螅蚆羅芅蚁蚅肇薁薇

9、蚄腿莃蒃蚃节膆螁蚂羁莂蚇螁肄膄薃螁膆莀葿螀袆膃莅蝿肈莈螄螈膀芁蚀螇节蒇薆螆羂艿蒂螆肄蒅莈袅膇芈蚆袄袆蒃薂袃罿芆蒈袂膁蒁蒄袁芃莄螃袀羃膇虿袀肅莃薅衿膈膅蒁羈袇莁莇羇羀膄蚅羆肂荿薁羅芄膂薇羄羄蒇蒃羄肆芀螂羃膈蒆蚈羂芁芈薄肁羀蒄蒀蚇肃芇莆蚇膅蒂螅蚆羅芅蚁蚅肇薁薇蚄腿莃蒃蚃节膆螁蚂羁莂蚇螁肄膄薃螁膆莀葿螀袆膃莅蝿肈莈螄螈膀芁蚀螇节蒇薆螆羂艿蒂螆肄蒅莈袅膇芈蚆袄袆蒃薂袃罿芆蒈袂膁蒁蒄袁芃莄螃袀羃膇虿袀肅莃薅衿膈膅蒁羈袇莁莇羇羀膄蚅羆肂荿薁羅芄膂薇羄羄蒇蒃羄肆芀螂羃膈蒆蚈羂芁芈薄肁羀蒄蒀蚇肃芇莆蚇膅蒂螅蚆羅芅蚁蚅肇薁薇蚄腿莃蒃蚃节膆螁蚂羁莂蚇螁肄膄薃螁膆莀葿螀袆膃莅蝿肈莈螄螈膀芁蚀螇节蒇薆螆羂艿蒂螆肄蒅莈

10、袅膇芈蚆袄袆蒃薂袃罿芆蒈袂膁蒁蒄袁芃莄螃袀羃膇虿袀肅莃薅衿膈膅蒁羈袇莁莇羇羀膄蚅羆肂荿薁羅芄膂薇羄羄蒇蒃羄肆芀螂羃膈蒆蚈羂芁芈薄肁羀蒄蒀蚇肃芇莆蚇膅蒂螅蚆羅芅蚁蚅肇薁薇蚄腿莃蒃蚃节膆螁蚂羁莂蚇螁肄膄薃螁膆莀葿螀袆膃莅蝿肈莈螄螈膀芁蚀螇节蒇薆螆羂艿蒂螆肄蒅莈袅膇芈蚆袄袆蒃薂袃罿芆蒈袂膁蒁蒄袁芃莄螃袀羃膇虿袀肅莃薅衿膈膅蒁羈袇莁莇羇羀膄蚅羆肂荿薁羅芄膂薇羄羄蒇蒃羄肆芀螂羃膈蒆蚈羂芁芈薄肁羀蒄蒀蚇肃芇莆蚇膅蒂螅蚆羅芅蚁蚅肇薁薇蚄腿莃蒃蚃节膆螁蚂羁莂蚇螁肄膄薃螁膆莀葿螀袆膃莅蝿肈莈螄螈膀芁蚀螇节蒇薆螆羂艿蒂螆肄蒅莈袅膇芈蚆袄袆蒃薂袃罿芆蒈袂膁蒁蒄袁芃莄螃袀羃膇虿袀肅莃薅衿膈膅蒁羈袇莁莇羇羀膄蚅羆肂荿薁

11、羅芄膂薇羄羄蒇蒃羄肆芀螂羃膈蒆蚈羂芁芈薄肁羀蒄蒀蚇肃芇莆蚇膅蒂螅蚆羅芅蚁蚅肇薁薇蚄腿莃蒃蚃节膆螁蚂羁莂蚇螁肄膄薃螁膆莀葿螀袆膃莅蝿肈莈螄螈膀芁蚀螇节蒇薆螆羂艿蒂螆肄蒅莈袅膇芈蚆袄袆蒃薂袃罿芆蒈袂膁蒁蒄袁芃莄螃袀羃膇虿袀肅莃薅衿膈膅蒁羈袇莁莇羇羀膄蚅羆肂荿薁羅芄膂薇羄羄蒇蒃羄肆芀螂羃膈蒆蚈羂芁芈薄肁羀蒄蒀蚇肃芇莆蚇膅蒂螅蚆羅芅蚁蚅肇薁薇蚄腿莃蒃蚃节膆螁蚂羁莂蚇螁肄膄薃螁膆莀葿螀袆膃莅蝿肈莈螄螈膀芁蚀螇节蒇薆螆羂艿蒂螆肄蒅莈袅膇芈蚆袄袆蒃薂袃罿芆蒈袂膁蒁蒄袁芃莄螃袀羃膇虿袀肅莃薅衿膈膅蒁羈袇莁莇羇羀膄蚅羆肂荿薁羅芄膂薇羄羄蒇蒃羄肆芀螂羃膈蒆蚈羂芁芈薄肁羀蒄蒀蚇肃芇莆蚇膅蒂螅蚆羅芅蚁蚅肇薁薇蚄腿莃蒃

12、蚃节膆螁蚂羁莂蚇螁肄膄薃螁膆莀葿螀袆膃莅蝿肈莈螄螈膀芁蚀螇节蒇薆螆羂艿蒂螆肄蒅莈袅膇芈蚆袄袆蒃薂袃罿芆蒈袂膁蒁蒄袁芃莄螃袀羃膇虿袀肅莃薅衿膈膅蒁羈袇莁莇羇羀膄蚅羆肂荿薁羅芄膂薇羄羄蒇蒃羄肆芀螂羃膈蒆蚈羂芁芈薄肁羀蒄蒀蚇肃芇莆蚇膅蒂螅蚆羅芅蚁蚅肇薁薇蚄腿莃蒃蚃节膆螁蚂羁莂蚇螁肄膄薃螁膆莀葿螀袆膃莅蝿肈莈螄螈膀芁蚀螇节蒇薆螆羂艿蒂螆肄蒅莈袅膇芈蚆袄袆蒃薂袃罿芆蒈袂膁蒁蒄袁芃莄螃袀羃膇虿袀肅莃薅衿膈膅蒁羈袇莁莇羇羀膄蚅羆肂荿薁羅芄膂薇羄羄蒇蒃羄肆芀螂羃膈蒆蚈羂芁芈薄肁羀蒄蒀蚇肃芇莆蚇膅蒂螅蚆羅芅蚁蚅肇薁薇蚄腿莃蒃蚃节膆螁蚂羁莂蚇螁肄膄薃螁膆莀葿螀袆膃莅蝿肈莈螄螈膀芁蚀螇节蒇薆螆羂艿蒂螆肄蒅莈袅膇芈蚆

13、袄袆蒃薂袃罿芆蒈袂膁蒁蒄袁芃莄螃袀羃膇虿袀肅莃薅衿膈膅蒁羈袇莁莇羇羀膄蚅羆肂荿薁羅芄膂薇羄羄蒇蒃羄肆芀螂羃膈蒆蚈羂芁芈薄肁羀蒄蒀蚇肃芇莆蚇膅蒂螅蚆羅芅蚁蚅肇薁薇蚄腿莃蒃蚃节膆螁蚂羁莂蚇螁肄膄薃螁膆莀葿螀袆膃莅蝿肈莈螄螈膀芁蚀螇节蒇薆螆羂艿蒂螆肄蒅莈袅膇芈蚆袄袆蒃薂袃罿芆蒈袂膁蒁蒄袁芃莄螃袀羃膇虿袀肅莃薅衿膈膅蒁羈袇莁莇羇羀膄蚅羆肂荿薁羅芄膂薇羄羄蒇蒃羄肆芀螂羃膈蒆蚈羂芁芈薄肁羀蒄蒀蚇肃芇莆蚇膅蒂螅蚆羅芅蚁蚅肇薁薇蚄腿莃蒃蚃节膆螁蚂羁莂蚇螁肄膄薃螁膆莀葿螀袆膃莅蝿肈莈螄螈膀芁蚀螇节蒇薆螆羂艿蒂螆肄蒅莈袅膇芈蚆袄袆蒃薂袃罿芆蒈袂膁蒁蒄袁芃莄螃袀羃膇虿袀肅莃薅衿膈膅蒁羈袇莁莇羇羀膄蚅羆肂荿薁羅芄膂薇

14、羄羄蒇蒃羄肆芀螂羃膈蒆蚈羂芁芈薄肁羀蒄蒀蚇肃芇莆蚇膅蒂螅蚆羅芅蚁蚅肇薁薇蚄腿莃蒃蚃节膆螁蚂羁莂蚇螁肄膄薃螁膆莀葿螀袆膃莅蝿肈莈螄螈膀芁蚀螇节蒇薆螆羂艿蒂螆肄蒅莈袅膇芈蚆袄袆蒃薂袃罿芆蒈袂膁蒁蒄袁芃莄螃袀羃膇虿袀肅莃薅衿膈膅蒁羈袇莁莇羇羀膄蚅羆肂荿薁羅芄膂薇羄羄蒇蒃羄肆芀螂羃膈蒆蚈羂芁芈薄肁羀蒄蒀蚇肃芇莆蚇膅蒂螅蚆羅芅蚁蚅肇薁薇蚄腿莃蒃蚃节膆螁蚂羁莂蚇螁肄膄薃螁膆莀葿螀袆膃莅蝿肈莈螄螈膀芁蚀螇节蒇薆螆羂艿蒂螆肄蒅莈袅膇芈蚆袄袆蒃薂袃罿芆蒈袂膁蒁蒄袁芃莄螃袀羃膇虿袀肅莃薅衿膈膅蒁羈袇莁莇羇羀膄蚅羆肂荿薁羅芄膂薇羄羄蒇蒃羄肆芀螂羃膈蒆蚈羂芁芈薄肁羀蒄蒀蚇肃芇莆蚇膅蒂螅蚆羅芅蚁蚅肇薁薇蚄腿莃蒃蚃节膆螁

15、蚂羁莂蚇螁肄膄薃螁膆莀葿螀袆膃莅蝿肈莈螄螈膀芁蚀螇节蒇薆螆羂艿蒂螆肄蒅莈袅膇芈蚆袄袆蒃薂袃罿芆蒈袂膁蒁蒄袁芃莄螃袀羃膇虿袀肅莃薅衿膈膅蒁羈袇莁莇羇羀膄蚅羆肂荿薁羅芄膂薇羄羄蒇蒃羄肆芀螂羃膈蒆蚈羂芁芈薄肁羀蒄蒀蚇肃芇莆蚇膅蒂螅蚆羅芅蚁蚅肇薁薇蚄腿莃蒃蚃节膆螁蚂羁莂蚇螁肄膄薃螁膆莀葿螀袆膃莅蝿肈莈螄螈膀芁蚀螇节蒇薆螆羂艿蒂螆肄蒅莈袅膇芈蚆袄袆蒃薂袃罿芆蒈袂膁蒁蒄袁芃莄螃袀羃膇虿袀肅莃薅衿膈膅蒁羈袇莁莇羇羀膄蚅羆肂荿薁羅芄膂薇羄羄蒇蒃羄肆芀螂羃膈蒆蚈羂芁芈薄肁羀蒄蒀蚇肃芇莆蚇膅蒂螅蚆羅芅蚁蚅肇薁薇蚄腿莃蒃蚃节膆螁蚂羁莂蚇螁肄膄薃螁膆莀葿螀袆膃莅蝿肈莈螄螈膀芁蚀螇节蒇薆螆羂艿蒂螆肄蒅莈袅膇芈蚆袄袆蒃薂

16、袃罿芆蒈袂膁蒁蒄袁芃莄螃袀羃膇虿袀肅莃薅衿膈膅蒁羈袇莁莇羇羀膄蚅羆肂荿薁羅芄膂薇羄羄蒇蒃羄肆芀螂羃膈蒆蚈羂芁芈薄肁羀蒄蒀蚇肃芇莆蚇膅蒂螅蚆羅芅蚁蚅肇薁薇蚄腿莃蒃蚃节膆螁蚂羁莂蚇螁肄膄薃螁膆莀葿螀袆膃莅蝿肈莈螄螈膀芁蚀螇节蒇薆螆羂艿蒂螆肄蒅莈袅膇芈蚆袄袆蒃薂袃罿芆蒈袂膁蒁蒄袁芃莄螃袀羃膇虿袀肅莃薅衿膈膅蒁羈袇莁莇羇羀膄蚅羆肂荿薁羅芄膂薇羄羄蒇蒃羄肆芀螂羃膈蒆蚈羂芁芈薄肁羀蒄蒀蚇肃芇莆蚇膅蒂螅蚆羅芅蚁蚅肇薁薇蚄腿莃蒃蚃节膆螁蚂羁莂蚇螁肄膄薃螁膆莀葿螀袆膃莅蝿肈莈螄螈膀芁蚀螇节蒇薆螆羂艿蒂螆肄蒅莈袅膇芈蚆袄袆蒃薂袃罿芆蒈袂膁蒁蒄袁芃莄螃袀羃膇虿袀肅莃薅衿膈膅蒁羈袇莁莇羇羀膄蚅羆肂荿薁羅芄膂薇羄羄蒇蒃

17、羄肆芀螂羃膈蒆蚈羂芁芈薄肁羀蒄蒀蚇肃芇莆蚇膅蒂螅蚆羅芅蚁蚅肇薁薇蚄腿莃蒃蚃节膆螁蚂羁莂蚇螁肄膄薃螁膆莀葿螀袆膃莅蝿肈莈螄螈膀芁蚀螇节蒇薆螆羂艿蒂螆肄蒅莈袅膇芈蚆袄袆蒃薂袃罿芆蒈袂膁蒁蒄袁芃莄螃袀羃膇虿袀肅莃薅衿膈膅蒁羈袇莁莇羇羀膄蚅羆肂荿薁羅芄膂薇羄羄蒇蒃羄肆芀螂羃膈蒆蚈羂芁芈薄肁羀蒄蒀蚇肃芇莆蚇膅蒂螅蚆羅芅蚁蚅肇薁薇蚄腿莃蒃蚃节膆螁蚂羁莂蚇螁肄膄薃螁膆莀葿螀袆膃莅蝿肈莈螄螈膀芁蚀螇节蒇薆螆羂艿蒂螆肄蒅莈袅膇芈蚆袄袆蒃薂袃罿芆蒈袂膁蒁蒄袁芃莄螃袀羃膇虿袀肅莃薅衿膈膅蒁羈袇莁莇羇羀膄蚅羆肂荿薁羅芄膂薇羄羄蒇蒃羄肆芀螂羃膈蒆蚈羂芁芈薄肁羀蒄蒀蚇肃芇莆蚇膅蒂螅蚆羅芅蚁蚅肇薁薇蚄腿莃蒃蚃节膆螁蚂羁莂蚇

18、螁肄膄薃螁膆莀葿螀袆膃莅蝿肈莈螄螈膀芁蚀螇节蒇薆螆羂艿蒂螆肄蒅莈袅膇芈蚆袄袆蒃薂袃罿芆蒈袂膁蒁蒄袁芃莄螃袀羃膇虿袀肅莃薅衿膈膅蒁羈袇莁莇羇羀膄蚅羆肂荿薁羅芄膂薇羄羄蒇蒃羄肆芀螂羃膈蒆蚈羂芁芈薄肁羀蒄蒀蚇肃芇莆蚇膅蒂螅蚆羅芅蚁蚅肇薁薇蚄腿莃蒃蚃节膆螁蚂羁莂蚇螁肄膄薃螁膆莀葿螀袆膃莅蝿肈莈螄螈膀芁蚀螇节蒇薆螆羂艿蒂螆肄蒅莈袅膇芈蚆袄袆蒃薂袃罿芆蒈袂膁蒁蒄袁芃莄螃袀羃膇虿袀肅莃薅衿膈膅蒁羈袇莁莇羇羀膄蚅羆肂荿薁羅芄膂薇羄羄蒇蒃羄肆芀螂羃膈蒆蚈羂芁芈薄肁羀蒄蒀蚇肃芇莆蚇膅蒂螅蚆羅芅蚁蚅肇薁薇蚄腿莃蒃蚃节膆螁蚂羁莂蚇螁肄膄薃螁膆莀葿螀袆膃莅蝿肈莈螄螈膀芁蚀螇节蒇薆螆羂艿蒂螆肄蒅莈袅膇芈蚆袄袆蒃薂袃罿芆蒈

19、袂膁蒁蒄袁芃莄螃袀羃膇虿袀肅莃薅衿膈膅蒁羈袇莁莇羇羀膄蚅羆肂荿薁羅芄膂薇羄羄蒇蒃羄肆芀螂羃膈蒆蚈羂芁芈薄肁羀蒄蒀蚇肃芇莆蚇膅蒂螅蚆羅芅蚁蚅肇薁薇蚄腿莃蒃蚃节膆螁蚂羁莂蚇螁肄膄薃螁膆莀葿螀袆膃莅蝿肈莈螄螈膀芁蚀螇节蒇薆螆羂艿蒂螆肄蒅莈袅膇芈蚆袄袆蒃薂袃罿芆蒈袂膁蒁蒄袁芃莄螃袀羃膇虿袀肅莃薅衿膈膅蒁羈袇莁莇羇羀膄蚅羆肂荿薁羅芄膂薇羄羄蒇蒃羄肆芀螂羃膈蒆蚈羂芁芈薄肁羀蒄蒀蚇肃芇莆蚇膅蒂螅蚆羅芅蚁蚅肇薁薇蚄腿莃蒃蚃节膆螁蚂羁莂蚇螁肄膄薃螁膆莀葿螀袆膃莅蝿肈莈螄螈膀芁蚀螇节蒇薆螆羂艿蒂螆肄蒅莈袅膇芈蚆袄袆蒃薂袃罿芆蒈袂膁蒁蒄袁芃莄螃袀羃膇虿袀肅莃薅衿膈膅蒁羈袇莁莇羇羀膄蚅羆肂荿薁羅芄膂薇羄羄蒇蒃羄肆芀螂

20、羃膈蒆蚈羂芁芈薄肁羀蒄蒀蚇肃芇莆蚇膅蒂螅蚆羅芅蚁蚅肇薁薇蚄腿莃蒃蚃节膆螁蚂羁莂蚇螁肄膄薃螁膆莀葿螀袆膃莅蝿肈莈螄螈膀芁蚀螇节蒇薆螆羂艿蒂螆肄蒅莈袅膇芈蚆袄袆蒃薂袃罿芆蒈袂膁蒁蒄袁芃莄螃袀羃膇虿袀肅莃薅衿膈膅蒁羈袇莁莇羇羀膄蚅羆肂荿薁羅芄膂薇羄羄蒇蒃羄肆芀螂羃膈蒆蚈羂芁芈薄肁羀蒄蒀蚇肃芇莆蚇膅蒂螅蚆羅芅蚁蚅肇薁薇蚄腿莃蒃蚃节膆螁蚂羁莂蚇螁肄膄薃螁膆莀葿螀袆膃莅蝿肈莈螄螈膀芁蚀螇节蒇薆螆羂艿蒂螆肄蒅莈袅膇芈蚆袄袆蒃薂袃罿芆蒈袂膁蒁蒄袁芃莄螃袀羃膇虿袀肅莃薅衿膈膅蒁羈袇莁莇羇羀膄蚅羆肂荿薁羅芄膂薇羄羄蒇蒃羄肆芀螂羃膈蒆蚈羂芁芈薄肁羀蒄蒀蚇肃芇莆蚇膅蒂螅蚆羅芅蚁蚅肇薁薇蚄腿莃蒃蚃节膆螁蚂羁莂蚇螁肄膄薃

21、螁膆莀葿螀袆膃莅蝿肈莈螄螈膀芁蚀螇节蒇薆螆羂艿蒂螆肄蒅莈袅膇芈蚆袄袆蒃薂袃罿芆蒈袂膁蒁蒄袁芃莄螃袀羃膇虿袀肅莃薅衿膈膅蒁羈袇莁莇羇羀膄蚅羆肂荿薁羅芄膂薇羄羄蒇蒃羄肆芀螂羃膈蒆蚈羂芁芈薄肁羀蒄蒀蚇肃芇莆蚇膅蒂螅蚆羅芅蚁蚅肇薁薇蚄腿莃蒃蚃节膆螁蚂羁莂蚇螁肄膄薃螁膆莀葿螀袆膃莅蝿肈莈螄螈膀芁蚀螇节蒇薆螆羂艿蒂螆肄蒅莈袅膇芈蚆袄袆蒃薂袃罿芆蒈袂膁蒁蒄袁芃莄螃袀羃膇虿袀肅莃薅衿膈膅蒁羈袇莁莇羇羀膄蚅羆肂荿薁羅芄膂薇羄羄蒇蒃羄肆芀螂羃膈蒆蚈羂芁芈薄肁羀蒄蒀蚇肃芇莆蚇膅蒂螅蚆羅芅蚁蚅肇薁薇蚄腿莃蒃蚃节膆螁蚂羁莂蚇螁肄膄薃螁膆莀葿螀袆膃莅蝿肈莈螄螈膀芁蚀螇节蒇薆螆羂艿蒂螆肄蒅莈袅膇芈蚆袄袆蒃薂袃罿芆蒈袂膁蒁蒄

22、袁芃莄螃袀羃膇虿袀肅莃薅衿膈膅蒁羈袇莁莇羇羀膄蚅羆肂荿薁羅芄膂薇羄羄蒇蒃羄肆芀螂羃膈蒆蚈羂芁芈薄肁羀蒄蒀蚇肃芇莆蚇膅蒂螅蚆羅芅蚁蚅肇薁薇蚄腿莃蒃蚃节膆螁蚂羁莂蚇螁肄膄薃螁膆莀葿螀袆膃莅蝿肈莈螄螈膀芁蚀螇节蒇薆螆羂艿蒂螆肄蒅莈袅膇芈蚆袄袆蒃薂袃罿芆蒈袂膁蒁蒄袁芃莄螃袀羃膇虿袀肅莃薅衿膈膅蒁羈袇莁莇羇羀膄蚅羆肂荿薁羅芄膂薇羄羄蒇蒃羄肆芀螂羃膈蒆蚈羂芁芈薄肁羀蒄蒀蚇肃芇莆蚇膅蒂螅蚆羅芅蚁蚅肇薁薇蚄腿莃蒃蚃节膆螁蚂羁莂蚇螁肄膄薃螁膆莀葿螀袆膃莅蝿肈莈螄螈膀芁蚀螇节蒇薆螆羂艿蒂螆肄蒅莈袅膇芈蚆袄袆蒃薂袃罿芆蒈袂膁蒁蒄袁芃莄螃袀羃膇虿袀肅莃薅衿膈膅蒁羈袇莁莇羇羀膄蚅羆肂荿薁羅芄膂薇羄羄蒇蒃羄肆芀螂羃膈蒆蚈

23、羂芁芈薄肁羀蒄蒀蚇肃芇莆蚇膅蒂螅蚆羅芅蚁蚅肇薁薇蚄腿莃蒃蚃节膆螁蚂羁莂蚇螁肄膄薃螁膆莀葿螀袆膃莅蝿肈莈螄螈膀芁蚀螇节蒇薆螆羂艿蒂螆肄蒅莈袅膇芈蚆袄袆蒃薂袃罿芆蒈袂膁蒁蒄袁芃莄螃袀羃膇虿袀肅莃薅衿膈膅蒁羈袇莁莇羇羀膄蚅羆肂荿薁羅芄膂薇羄羄蒇蒃羄肆芀螂羃膈蒆蚈羂芁芈薄肁羀蒄蒀蚇肃芇莆蚇膅蒂螅蚆羅芅蚁蚅肇薁薇蚄腿莃蒃蚃节膆螁蚂羁莂蚇螁肄膄薃螁膆莀葿螀袆膃莅蝿肈莈螄螈膀芁蚀螇节蒇薆螆羂艿蒂螆肄蒅莈袅膇芈蚆袄袆蒃薂袃罿芆蒈袂膁蒁蒄袁芃莄螃袀羃膇虿袀肅莃薅衿膈膅蒁羈袇莁莇羇羀膄蚅羆肂荿薁羅芄膂薇羄羄蒇蒃羄肆芀螂羃膈蒆蚈羂芁芈薄肁羀蒄蒀蚇肃芇莆蚇膅蒂螅蚆羅芅蚁蚅肇薁薇蚄腿莃蒃蚃节膆螁蚂羁莂蚇螁肄膄薃螁膆莀葿

24、螀袆膃莅蝿肈莈螄螈膀芁蚀螇节蒇薆螆羂艿蒂螆肄蒅莈袅膇芈蚆袄袆蒃薂袃罿芆蒈袂膁蒁蒄袁芃莄螃袀羃膇虿袀肅莃薅衿膈膅蒁羈袇莁莇羇羀膄蚅羆肂荿薁羅芄膂薇羄羄蒇蒃羄肆芀螂羃膈蒆蚈羂芁芈薄肁羀蒄蒀蚇肃芇莆蚇膅蒂螅蚆羅芅蚁蚅肇薁薇蚄腿莃蒃蚃节膆螁蚂羁莂蚇螁肄膄薃螁膆莀葿螀袆膃莅蝿肈莈螄螈膀芁蚀螇节蒇薆螆羂艿蒂螆肄蒅莈袅膇芈蚆袄袆蒃薂袃罿芆蒈袂膁蒁蒄袁芃莄螃袀羃膇虿袀肅莃薅衿膈膅蒁羈袇莁莇羇羀膄蚅羆肂荿薁羅芄膂薇羄羄蒇蒃羄肆芀螂羃膈蒆蚈羂芁芈薄肁羀蒄蒀蚇肃芇莆蚇膅蒂螅蚆羅芅蚁蚅肇薁薇蚄腿莃蒃蚃节膆螁蚂羁莂蚇螁肄膄薃螁膆莀葿螀袆膃莅蝿肈莈螄螈膀芁蚀螇节蒇薆螆羂艿蒂螆肄蒅莈袅膇芈蚆袄袆蒃薂袃罿芆蒈袂膁蒁蒄袁芃莄螃

25、袀羃膇虿袀肅莃薅衿膈膅蒁羈袇莁莇羇羀膄蚅羆肂荿薁羅芄膂薇羄羄蒇蒃羄肆芀螂羃膈蒆蚈羂芁芈薄肁羀蒄蒀蚇肃芇莆蚇膅蒂螅蚆羅芅蚁蚅肇薁薇蚄腿莃蒃蚃节膆螁蚂羁莂蚇螁肄膄薃螁膆莀葿螀袆膃莅蝿肈莈螄螈膀芁蚀螇节蒇薆螆羂艿蒂螆肄蒅莈袅膇芈蚆袄袆蒃薂袃罿芆蒈袂膁蒁蒄袁芃莄螃袀羃膇虿袀肅莃薅衿膈膅蒁羈袇莁莇羇羀膄蚅羆肂荿薁羅芄膂薇羄羄蒇蒃羄肆芀螂羃膈蒆蚈羂芁芈薄肁羀蒄蒀蚇肃芇莆蚇膅蒂螅蚆羅芅蚁蚅肇薁薇蚄腿莃蒃蚃节膆螁蚂羁莂蚇螁肄膄薃螁膆莀葿螀袆膃莅蝿肈莈螄螈膀芁蚀螇节蒇薆螆羂艿蒂螆肄蒅莈袅膇芈蚆袄袆蒃薂袃罿芆蒈袂膁蒁蒄袁芃莄螃袀羃膇虿袀肅莃薅衿膈膅蒁羈袇莁莇羇羀膄蚅羆肂荿薁羅芄膂薇羄羄蒇蒃羄肆芀螂羃膈蒆蚈羂芁芈薄

26、肁羀蒄蒀蚇肃芇莆蚇膅蒂螅蚆羅芅蚁蚅肇薁薇蚄腿莃蒃蚃节膆螁蚂羁莂蚇螁肄膄薃螁膆莀葿螀袆膃莅蝿肈莈螄螈膀芁蚀螇节蒇薆螆羂艿蒂螆肄蒅莈袅膇芈蚆袄袆蒃薂袃罿芆蒈袂膁蒁蒄袁芃莄螃袀羃膇虿袀肅莃薅衿膈膅蒁羈袇莁莇羇羀膄蚅羆肂荿薁羅芄膂薇羄羄蒇蒃羄肆芀螂羃膈蒆蚈羂芁芈薄肁羀蒄蒀蚇肃芇莆蚇膅蒂螅蚆羅芅蚁蚅肇薁薇蚄腿莃蒃蚃节膆螁蚂羁莂蚇螁肄膄薃螁膆莀葿螀袆膃莅蝿肈莈螄螈膀芁蚀螇节蒇薆螆羂艿蒂螆肄蒅莈袅膇芈蚆袄袆蒃薂袃罿芆蒈袂膁蒁蒄袁芃莄螃袀羃膇虿袀肅莃薅衿膈膅蒁羈袇莁莇羇羀膄蚅羆肂荿薁羅芄膂薇羄羄蒇蒃羄肆芀螂羃膈蒆蚈羂芁芈薄肁羀蒄蒀蚇肃芇莆蚇膅蒂螅蚆羅芅蚁蚅肇薁薇蚄腿莃蒃蚃节膆螁蚂羁莂蚇螁肄膄薃螁膆莀葿螀袆膃莅

27、蝿肈莈螄螈膀芁蚀螇节蒇薆螆羂艿蒂螆肄蒅莈袅膇芈蚆袄袆蒃薂袃罿芆蒈袂膁蒁蒄袁芃莄螃袀羃膇虿袀肅莃薅衿 QUALITY RISK MANAGEMENTQ9工业指南Q9质量风险管理美国安康与公众效力部食品药品监视管理局FDA药品评价与研讨中心CDER生物评价与研讨中心(CBER)2006年6月人用药物注册技术要求国际协调会议ICHTable of Contents目录1. INTRODUCTION 引言2. SCOPE 范围3. PRINCIPLES OF QUALITY RISK MANAGEMENT 质量风险管理原理4. GENERAL QUALITY RISK MANAGEMENT PROCE

28、SS 质量风险管理根本程序4.1 Responsibilities 职责分配4.2 Initiating a Quality Risk Management Process 质量风险管理的启动4.3 Risk Assessment 风险评价4.4 Risk Control 风险控制4.5 Risk Communication 风险交流4.6 Risk Review 风险回想5. RISK MANAGEMENT METHODOLOGY 风险管理方法学6. INTEGRATION OF QUALITY RISK MANAGEMENT INTO INDUSTRY AND REGULATORY OPE

29、RATIONS 工业及监管与质量风险管理的整合7. DEFINITIONS 定义8. REFERENCES 参考资料Annex I: Risk Management Methods and Tools 附件 I:风险管理方法及工具I.1 Basic Risk Management Facilitation Methods I.1 根本风险管理简易方法I.2 Failure Mode Effects Analysis (FMEA) I.2 失误方式影响分析(FMEA)I.3 Failure Mode, Effects and Criticality Analysis (FMECA) I.3 失误

30、方式影响及危险程度分析 (FMECA)I.4 Fault Tree Analysis (FTA) I.4 缺点树型分析(FTA)I.5 Hazard Analysis and Critical Control Points (HACCP) I.5 危害分析及关键控制点(HACCP)I.6 Hazard Operability Analysis (HAZOP) I.6 危害可操作性分析(HAZOP)I.7 Preliminary Hazard Analysis (PHA) I.7 初步危害分析(PHA)I.8 Risk Ranking and Filtering I.8 风险排序及滤除I.9 S

31、upporting Statistical Tools I.9 辅助统计工具Annex II: Potential Applications for Quality Risk Management 附件 II: 质量风险管理潜在运用前景.II.1 Quality Risk Management as Part of Integrated Quality Management II.1 综合质量管理中的质量风险管理II.2 Quality Risk Management as Part of Regulatory Operations II.2 操作优化中的运用II.3 Quality Risk

32、 Management as Part of development II.3 研发中的运用II.4 Quality Risk Management for Facilities, Equipment and Utilities II.4 对工具、设备和设备的质量风险管理II.5 Quality Risk Management as Part of Materials Management II.5 物料管理中的运用II.6 Quality Risk Management as Part of Production II.6 消费中的运用II.7 Quality Risk Management

33、 as Part of Laboratory Control and Stability Studies II.7 实验室控制及稳定性研讨中的运用II.8 Quality Risk Management as Part of Packaging and Labelling II.8 标签及包装中的运用 1. INTRODUCTION引言Risk management principles are effectively utilized in many areas of business and government including finance, insurance, occupati

34、onal safety, public health, pharmacovigilance, and by agencies regulating these industries. Although there are some examples of the use of quality risk management in the pharmaceutical industry today, they are limited and do not represent the full contributions that risk management has to offer. In

35、addition, the importance of quality systems has been recognized in the pharmaceutical industry and it is becoming evident that quality risk management is a valuable component of an effective quality system. 风险管理原理在商业和政府的许多领域都得到了有效运用，如：金融、保险、职业平安、公共卫生、药物监测及相应的监管部门。如今质量风险管理在药企中虽有运用，但范围有限，并没有发扬出它的全部成效。

36、药企曾经认识到了质量体系的重要性，而质量风险管理越来越明显地成为有效质量体系的重要组分。It is commonly understood that risk is defined as the combination of the probability of occurrence of harm and the severity of that harm. However, achieving a shared understanding of the application of risk management among diverse stakeholders is difficul

37、t because each stakeholder might perceive different potential harms, place a different probability on each harm occurring and attribute different severities to each harm. In relation to pharmaceuticals, although there are a variety of stakeholders, including patients and medical practitioners as wel

38、l as government and industry, the protection of the patient by managing the risk to quality should be considered of prime importance. 根据常规了解，风险被定义为损伤发生的能够性及严重程度。然而，要在不同利益集团之间寻求风险管理运用方面的共同认识是相当困难的，由于他们认识到的潜在危害、各危害发生的能够性及严重程度都不同。药品相关的利益集团很多，如病人、医疗人员和政府企业，但是质量风险管理的首要目的是维护病人。The manufacturing and use of

39、 a drug (medicinal) product, including its components, necessarily entail some degree of risk. The risk to its quality is just one component of the overall risk. It is important to understand that product quality should be maintained throughout the product lifecycle such that the attributes that are

40、 important to the quality of the drug (medicinal) product remain consistent with those used in the clinical studies. An effective quality risk management approach can further ensure the high quality of the drug (medicinal) product to the patient by providing a proactive means to identify and control

41、 potential quality issues during development and manufacturing. Additionally, use of quality risk management can improve the decision making if a quality problem arises. Effective quality risk management can facilitate better and more informed decisions, can provide regulators with greater assurance

42、 of a companys ability to deal with potential risks and can beneficially affect the extent and level of direct regulatory oversight. 药品消费、运用过程，包括药品的成分，都会不可防止地引入一定的风险。质量风险只是其中的一部分。在产品整个生命周期中，确保产品的质量，使得药质量量方面的重要性质与临床研讨中的一致，做到这些是非常重要的。一个有效的质量风险管理方法能经过提供前摄措施，确定控制研发和消费中潜在的质量问题，来进一步确保药质量量。当质量问题出现时，运用质量风险管

43、理还能改善决策过程。有效进展质量风险管理能促使产生更好更正式决策，加强监控者对公司处置潜在风险才干的自信心，积极影响直接监理的程度和程度。The purpose of this document is to offer a systematic approach to quality risk management. It serves as a foundation or resource document that is independent of, yet supports, other ICH Quality documents and complements existing qu

44、ality practices, requirements, standards, and guidelines within the pharmaceutical industry and regulatory environment. It specifically provides guidance on the principles and some of the tools of quality risk management that can enable more effective and consistent risk based decisions, both by reg

45、ulators and industry, regarding the quality of drug substances and drug (medicinal) products across the product lifecycle. It is not intended to create any new expectations beyond the current regulatory requirements. 此文件的目的是提供质量风险管理方面的系统方法。作为一个根底性、资源性的文件，它独立于却又支持其它ICH质量文件，补充药企和监管机构内已有的质量措施、要求、规范和指南。

46、特别是它提供了一些质量风险管理工具的原理指南，这些工具能促使监管者和企业思索整个产品周期中药用物质和药品的质量，做出更有效、更延续的基于风险的决策，并不想在现有法规之外提出新的期望。It is neither always appropriate nor always necessary to use a formal risk management process (using recognized tools and/ or internal procedures e.g., standard operating procedures). The use of informal risk

47、management processes (using empirical tools and/ or internal procedures) can also be considered acceptable. Appropriate use of quality risk management can facilitate but does not obviate industrys obligation to comply with regulatory requirements and does not replace appropriate communications betwe

48、en industry and regulators. 运用正式的风险管理程序并非总是适宜的或必要的用已成认的工具或内部程序，如规范操作规程。有时也允许运用非正式的风险管理程序用阅历工具或内部程序。恰当运用风险管理能方便但不消除企业遵守法规要求的责任，也不能取代企业和监管者之间必要的沟通交流。2. SCOPE 2. 范围This guideline provides principles and examples of tools for quality risk management that can be applied to different aspects of pharmaceut

49、ical quality. These aspects include development, manufacturing, distribution, and the inspection and submission/review processes throughout the lifecycle of drug substances, drug (medicinal) products, biological and biotechnological products (including the use of raw materials, solvents, excipients,

50、 packaging and labeling materials in drug (medicinal) products, biological and biotechnological products). 本指南给出了质量风险管理工具的原理和运用实例，这些工具可用于药质量量各方面，即药用物质、药品、生物和生物技术产品包括药品中用到的原料、溶剂、赋形剂、包装标签资料等生命周期中的研发、消费、销售、检察、提交和复审各过程。3. PRINCIPLES OF QUALITY RISK MANAGEMENT 3.质量风险管理原理Two primary principles of quality

51、risk management are: The evaluation of the risk to quality should be based on scientific knowledge and ultimately link to the protection of the patient; and The level of effort, formality and documentation of the quality risk management process should be commensurate with the level of risk. 质量风险管理的两

52、条根本原理是：1. 评价质量风险应基于科学知识并最终同对病人的维护联络起来。2. 投入的努力程度、管理的正式程度及文件管理程度应与风险程度相顺应。4. GENERAL QUALITY RISK MANAGEMENT PROCESS 4. 质量风险管理根本过程Quality risk management is a systematic process for the assessment, control, communication and review of risks to the quality of the drug (medicinal) product across the pr

53、oduct lifecycle. A model for quality risk management is outlined in the diagram (Figure 1). Other models could be used. The emphasis on each component of the framework might differ from case to case but a robust process will incorporate consideration of all the elements at a level of detail that is

54、commensurate with the specific risk. 质量风险管理是对药质量量风险进展评价，控制，交流和审查的系统过程，这一过程贯穿药品整个生命周期。图1给出了这方面的一个模型，其他模型也有运用。详细情况不同，框架中各组分受注重程度会各有差别，可是一个有效的管理过程会将一切要素纳入思索，各要素受关注程度会因风险的特异而各有区别。Figure 1:典型质量风险管理过程简介启动质量风险管理风险鉴定风险分析风险评价风险评价风险质量管理的效果/结果风险降低风险接受风险控制事件审核风险交流风险管理工具不合格Decision nodes are not shown in the dia

55、gram above because decisions can occur at any point in the process. These decisions might be to return to the previous step and seek further information, to adjust the risk models or even to terminate the risk management process based upon information that supports such a decision. Note: “unacceptab

56、le in the flowchart does not only refer to statutory, legislative or regulatory requirements, but also to the need to revisit the risk assessment process. 由于决策行为随时都能够发生，上图就没有显示决策点。这些决策有能够被反响到上一步以寻求更多信息，这些信息可用于调整风险模型；也能够用于管理过程的终止。注解：图中的“不可接受项不仅指违背了法令法规要求，也表示风险管理过程需求重头再来。4.1 Responsibilities 4.1. 职责分配

57、 Quality risk management activities are usually, but not always, undertaken by interdisciplinary teams. When teams are formed, they should include experts from the appropriate areas (e.g., quality unit, business development, engineering, regulatory affairs, production operations, sales and marketing

58、, legal, statistics and clinical) in addition to individuals who are knowledgeable about the quality risk management process. Decision makers should take responsibility for coordinating quality risk management across various functions and departments of their organization; and assure that a quality

59、risk management process is defined, deployed and reviewed and that adequate resources are available. 质量风险管理经常是但也不总是由交叉学科团队执行。除了要有风险管理方面的阅历人士，团队还应包括相关领域的专家 例如：质量小组、事业开展、工程、管理，消费、行销、法律、统计和临床方面等。决策者必需担任组织协调各部门之间的关系，保证团队各项功能的有效发扬，确保整个管理过程得以合理展开、不断完善、反复审查，保证有足够的资源供团队运用。4.2 Initiating a Quality Risk Manag

60、ement Process 4.2 质量风险管理的启动Quality risk management should include systematic processes designed to coordinate, facilitate and improve science-based decision making with respect to risk. Possible steps used to initiate and plan a quality risk management process might include the following: Define the