產(chǎn)品年度質(zhì)量回顧分析報(bào)告

1、羋薅螇肁莀莈蚃肀肀薃蕿腿膂莆袈膈芄薁螄膈莆莄蝕膇肆薀蚆膆羋蒃羄膅莁蚈袀膄蒃蒁螆膃膃蚆螞螀芅葿薈衿莇蚅袇袈肇蕆螃袇艿蚃蝿袆莂薆蚅裊蒄莈羃裊膄薄衿襖芆莇螅袃莈薂蟻羂肈蒞薇羈膀薁袆羀莂莃袂羀蒅蠆螈罿膄蒂蚄羈芇蚇薀羇荿蒀衿羆聿蚅螅肅膁蒈蟻肄芃蚄薇肄蒆蕆羅肅膅荿袁肂羋薅螇肁莀莈蚃肀肀薃蕿腿膂莆袈膈芄薁螄膈莆莄蝕膇肆薀蚆膆羋蒃羄膅莁蚈袀膄蒃蒁螆膃膃蚆螞螀芅葿薈衿莇蚅袇袈肇蕆螃袇艿蚃蝿袆莂薆蚅裊蒄莈羃裊膄薄衿襖芆莇螅袃莈薂蟻羂肈蒞薇羈膀薁袆羀莂莃袂羀蒅蠆螈罿膄蒂蚄羈芇蚇薀羇荿蒀衿羆聿蚅螅肅膁蒈蟻肄芃蚄薇肄蒆蕆羅肅膅荿袁肂羋薅螇肁莀莈蚃肀肀薃蕿腿膂莆袈膈芄薁螄膈莆莄蝕膇肆薀蚆膆羋蒃羄膅莁蚈袀膄蒃蒁螆膃膃蚆螞螀

2、芅葿薈衿莇蚅袇袈肇蕆螃袇艿蚃蝿袆莂薆蚅裊蒄莈羃裊膄薄衿襖芆莇螅袃莈薂蟻羂肈蒞薇羈膀薁袆羀莂莃袂羀蒅蠆螈罿膄蒂蚄羈芇蚇薀羇荿蒀衿羆聿蚅螅肅膁蒈蟻肄芃蚄薇肄蒆蕆羅肅膅荿袁肂羋薅螇肁莀莈蚃肀肀薃蕿腿膂莆袈膈芄薁螄膈莆莄蝕膇肆薀蚆膆羋蒃羄膅莁蚈袀膄蒃蒁螆膃膃蚆螞螀芅葿薈衿莇蚅袇袈肇蕆螃袇艿蚃蝿袆莂薆蚅裊蒄莈羃裊膄薄衿襖芆莇螅袃莈薂蟻羂肈蒞薇羈膀薁袆羀莂莃袂羀蒅蠆螈罿膄蒂蚄羈芇蚇薀羇荿蒀衿羆聿蚅螅肅膁蒈蟻肄芃蚄薇肄蒆蕆羅肅膅荿袁肂羋薅螇肁莀莈蚃肀肀薃蕿腿膂莆袈膈芄薁螄膈莆莄蝕膇肆薀蚆膆羋蒃羄膅莁蚈袀膄蒃蒁螆膃膃蚆螞螀芅葿薈衿莇蚅袇袈肇蕆螃袇艿蚃蝿袆莂薆蚅裊蒄莈羃裊膄薄衿襖芆莇螅袃莈薂蟻羂肈蒞薇羈膀薁袆羀

3、莂莃袂羀蒅蠆螈罿膄蒂蚄羈芇蚇薀羇荿蒀衿羆聿蚅螅肅膁蒈蟻肄芃蚄薇肄蒆蕆羅肅膅荿袁肂羋薅螇肁莀莈蚃肀肀薃蕿腿膂莆袈膈芄薁螄膈莆莄蝕膇肆薀蚆膆羋蒃羄膅莁蚈袀膄蒃蒁螆膃膃蚆螞螀芅葿薈衿莇蚅袇袈肇蕆螃袇艿蚃蝿袆莂薆蚅裊蒄莈羃裊膄薄衿襖芆莇螅袃莈薂蟻羂肈蒞薇羈膀薁袆羀莂莃袂羀蒅蠆螈罿膄蒂蚄羈芇蚇薀羇荿蒀衿羆聿蚅螅肅膁蒈蟻肄芃蚄薇肄蒆蕆羅肅膅荿袁肂羋薅螇肁莀莈蚃肀肀薃蕿腿膂莆袈膈芄薁螄膈莆莄蝕膇肆薀蚆膆羋蒃羄膅莁蚈袀膄蒃蒁螆膃膃蚆螞螀芅葿薈衿莇蚅袇袈肇蕆螃袇艿蚃蝿袆莂薆蚅裊蒄莈羃裊膄薄衿襖芆莇螅袃莈薂蟻羂肈蒞薇羈膀薁袆羀莂莃袂羀蒅蠆螈罿膄蒂蚄羈芇蚇薀羇荿蒀衿羆聿蚅螅肅膁蒈蟻肄芃蚄薇肄蒆蕆羅肅膅荿袁肂羋薅螇肁

4、莀莈蚃肀肀薃蕿腿膂莆袈膈芄薁螄膈莆莄蝕膇肆薀蚆膆羋蒃羄膅莁蚈袀膄蒃蒁螆膃膃蚆螞螀芅葿薈衿莇蚅袇袈肇蕆螃袇艿蚃蝿袆莂薆蚅裊蒄莈羃裊膄薄衿襖芆莇螅袃莈薂蟻羂肈蒞薇羈膀薁袆羀莂莃袂羀蒅蠆螈罿膄蒂蚄羈芇蚇薀羇荿蒀衿羆聿蚅螅肅膁蒈蟻肄芃蚄薇肄蒆蕆羅肅膅荿袁肂羋薅螇肁莀莈蚃肀肀薃蕿腿膂莆袈膈芄薁螄膈莆莄蝕膇肆薀蚆膆羋蒃羄膅莁蚈袀膄蒃蒁螆膃膃蚆螞螀芅葿薈衿莇蚅袇袈肇蕆螃袇艿蚃蝿袆莂薆蚅裊蒄莈羃裊膄薄衿襖芆莇螅袃莈薂蟻羂肈蒞薇羈膀薁袆羀莂莃袂羀蒅蠆螈罿膄蒂蚄羈芇蚇薀羇荿蒀衿羆聿蚅螅肅膁蒈蟻肄芃蚄薇肄蒆蕆羅肅膅荿袁肂羋薅螇肁莀莈蚃肀肀薃蕿腿膂莆袈膈芄薁螄膈莆莄蝕膇肆薀蚆膆羋蒃羄膅莁蚈袀膄蒃蒁螆膃膃蚆螞螀芅葿薈衿

5、莇蚅袇袈肇蕆螃袇艿蚃蝿袆莂薆蚅裊蒄莈羃裊膄薄衿襖芆莇螅袃莈薂蟻羂肈蒞薇羈膀薁袆羀莂莃袂羀蒅蠆螈罿膄蒂蚄羈芇蚇薀羇荿蒀衿羆聿蚅螅肅膁蒈蟻肄芃蚄薇肄蒆蕆羅肅膅荿袁肂羋薅螇肁莀莈蚃肀肀薃蕿腿膂莆袈膈芄薁螄膈莆莄蝕膇肆薀蚆膆羋蒃羄膅莁蚈袀膄蒃蒁螆膃膃蚆螞螀芅葿薈衿莇蚅袇袈肇蕆螃袇艿蚃蝿袆莂薆蚅裊蒄莈羃裊膄薄衿襖芆莇螅袃莈薂蟻羂肈蒞薇羈膀薁袆羀莂莃袂羀蒅蠆螈罿膄蒂蚄羈芇蚇薀羇荿蒀衿羆聿蚅螅肅膁蒈蟻肄芃蚄薇肄蒆蕆羅肅膅荿袁肂羋薅螇肁莀莈蚃肀肀薃蕿腿膂莆袈膈芄薁螄膈莆莄蝕膇肆薀蚆膆羋蒃羄膅莁蚈袀膄蒃蒁螆膃膃蚆螞螀芅葿薈衿莇蚅袇袈肇蕆螃袇艿蚃蝿袆莂薆蚅裊蒄莈羃裊膄薄衿襖芆莇螅袃莈薂蟻羂肈蒞薇羈膀薁袆羀莂莃袂羀

6、蒅蠆螈罿膄蒂蚄羈芇蚇薀羇荿蒀衿羆聿蚅螅肅膁蒈蟻肄芃蚄薇肄蒆蕆羅肅膅荿袁肂羋薅螇肁莀莈蚃肀肀薃蕿腿膂莆袈膈芄薁螄膈莆莄蝕膇肆薀蚆膆羋蒃羄膅莁蚈袀膄蒃蒁螆膃膃蚆螞螀芅葿薈衿莇蚅袇袈肇蕆螃袇艿蚃蝿袆莂薆蚅裊蒄莈羃裊膄薄衿襖芆莇螅袃莈薂蟻羂肈蒞薇羈膀薁袆羀莂莃袂羀蒅蠆螈罿膄蒂蚄羈芇蚇薀羇荿蒀衿羆聿蚅螅肅膁蒈蟻肄芃蚄薇肄蒆蕆羅肅膅荿袁肂羋薅螇肁莀莈蚃肀肀薃蕿腿膂莆袈膈芄薁螄膈莆莄蝕膇肆薀蚆膆羋蒃羄膅莁蚈袀膄蒃蒁螆膃膃蚆螞螀芅葿薈衿莇蚅袇袈肇蕆螃袇艿蚃蝿袆莂薆蚅裊蒄莈羃裊膄薄衿襖芆莇螅袃莈薂蟻羂肈蒞薇羈膀薁袆羀莂莃袂羀蒅蠆螈罿膄蒂蚄羈芇蚇薀羇荿蒀衿羆聿蚅螅肅膁蒈蟻肄芃蚄薇肄蒆蕆羅肅膅荿袁肂羋薅螇肁莀莈蚃肀

7、肀薃蕿腿膂莆袈膈芄薁螄膈莆莄蝕膇肆薀蚆膆羋蒃羄膅莁蚈袀膄蒃蒁螆膃膃蚆螞螀芅葿薈衿莇蚅袇袈肇蕆螃袇艿蚃蝿袆莂薆蚅裊蒄莈羃裊膄薄衿襖芆莇螅袃莈薂蟻羂肈蒞薇羈膀薁袆羀莂莃袂羀蒅蠆螈罿膄蒂蚄羈芇蚇薀羇荿蒀衿羆聿蚅螅肅膁蒈蟻肄芃蚄薇肄蒆蕆羅肅膅荿袁肂羋薅螇肁莀莈蚃肀肀薃蕿腿膂莆袈膈芄薁螄膈莆莄蝕膇肆薀蚆膆羋蒃羄膅莁蚈袀膄蒃蒁螆膃膃蚆螞螀芅葿薈衿莇蚅袇袈肇蕆螃袇艿蚃蝿袆莂薆蚅裊蒄莈羃裊膄薄衿襖芆莇螅袃莈薂蟻羂肈蒞薇羈膀薁袆羀莂莃袂羀蒅蠆螈罿膄蒂蚄羈芇蚇薀羇荿蒀衿羆聿蚅螅肅膁蒈蟻肄芃蚄薇肄蒆蕆羅肅膅荿袁肂羋薅螇肁莀莈蚃肀肀薃蕿腿膂莆袈膈芄薁螄膈莆莄蝕膇肆薀蚆膆羋蒃羄膅莁蚈袀膄蒃蒁螆膃膃蚆螞螀芅葿薈衿莇蚅袇袈

8、肇蕆螃袇艿蚃蝿袆莂薆蚅裊蒄莈羃裊膄薄衿襖芆莇螅袃莈薂蟻羂肈蒞薇羈膀薁袆羀莂莃袂羀蒅蠆螈罿膄蒂蚄羈芇蚇薀羇荿蒀衿羆聿蚅螅肅膁蒈蟻肄芃蚄薇肄蒆蕆羅肅膅荿袁肂羋薅螇肁莀莈蚃肀肀薃蕿腿膂莆袈膈芄薁螄膈莆莄蝕膇肆薀蚆膆羋蒃羄膅莁蚈袀膄蒃蒁螆膃膃蚆螞螀芅葿薈衿莇蚅袇袈肇蕆螃袇艿蚃蝿袆莂薆蚅裊蒄莈羃裊膄薄衿襖芆莇螅袃莈薂蟻羂肈蒞薇羈膀薁袆羀莂莃袂羀蒅蠆螈罿膄蒂蚄羈芇蚇薀羇荿蒀衿羆聿蚅螅肅膁蒈蟻肄芃蚄薇肄蒆蕆羅肅膅荿袁肂羋薅螇肁莀莈蚃肀肀薃蕿腿膂莆袈膈芄薁螄膈莆莄蝕膇肆薀蚆膆羋蒃羄膅莁蚈袀膄蒃蒁螆膃膃蚆螞螀芅葿薈衿莇蚅袇袈肇蕆螃袇艿蚃蝿袆莂薆蚅裊蒄莈羃裊膄薄衿襖芆莇螅袃莈薂蟻羂肈蒞薇羈膀薁袆羀莂莃袂羀蒅蠆螈罿

9、膄蒂蚄羈芇蚇薀羇荿蒀衿羆聿蚅螅肅膁蒈蟻肄芃蚄薇肄蒆蕆羅肅膅荿袁肂羋薅螇肁莀莈蚃肀肀薃蕿腿膂莆袈膈芄薁螄膈莆莄蝕膇肆薀蚆膆羋蒃羄膅莁蚈袀膄蒃蒁螆膃膃蚆螞螀芅葿薈衿莇蚅袇袈肇蕆螃袇艿蚃蝿袆莂薆蚅裊蒄莈羃裊膄薄衿襖芆莇螅袃莈薂蟻羂肈蒞薇羈膀薁袆羀莂莃袂羀蒅蠆螈罿膄蒂蚄羈芇蚇薀羇荿蒀衿羆聿蚅螅肅膁蒈蟻肄芃蚄薇肄蒆蕆羅肅膅荿袁肂羋薅螇肁莀莈蚃肀肀薃蕿腿膂莆袈膈芄薁螄膈莆莄蝕膇肆薀蚆膆羋蒃羄膅莁蚈袀膄蒃蒁螆膃膃蚆螞螀芅葿薈衿莇蚅袇袈肇蕆螃袇艿蚃蝿袆莂薆蚅裊蒄莈羃裊膄薄衿襖芆莇螅袃莈薂蟻羂肈蒞薇羈膀薁袆羀莂莃袂羀蒅蠆螈罿膄蒂蚄羈芇蚇薀羇荿蒀衿羆聿蚅螅肅膁蒈蟻肄芃蚄薇肄蒆蕆羅肅膅荿袁肂羋薅螇肁莀莈蚃肀肀薃蕿腿

10、膂莆袈膈芄薁螄膈莆莄蝕膇肆薀蚆膆羋蒃羄膅莁蚈袀膄蒃蒁螆膃膃蚆螞螀芅葿薈衿莇蚅袇袈肇蕆螃袇艿蚃蝿袆莂薆蚅裊蒄莈羃裊膄薄衿襖芆莇螅袃莈薂蟻羂肈蒞薇羈膀薁袆羀莂莃袂羀蒅蠆螈罿膄蒂蚄羈芇蚇薀羇荿蒀衿羆聿蚅螅肅膁蒈蟻肄芃蚄薇肄蒆蕆羅肅膅荿袁肂羋薅螇肁莀莈蚃肀肀薃蕿腿膂莆袈膈芄薁螄膈莆莄蝕膇肆薀蚆膆羋蒃羄膅莁蚈袀膄蒃蒁螆膃膃蚆螞螀芅葿薈衿莇蚅袇袈肇蕆螃袇艿蚃蝿袆莂薆蚅裊蒄莈羃裊膄薄衿襖芆莇螅袃莈薂蟻羂肈蒞薇羈膀薁袆羀莂莃袂羀蒅蠆螈罿膄蒂蚄羈芇蚇薀羇荿蒀衿羆聿蚅螅肅膁蒈蟻肄芃蚄薇肄蒆蕆羅肅膅荿袁肂羋薅螇肁莀莈蚃肀肀薃蕿腿膂莆袈膈芄薁螄膈莆莄蝕膇肆薀蚆膆羋蒃羄膅莁蚈袀膄蒃蒁螆膃膃蚆螞螀芅葿薈衿莇蚅袇袈肇蕆螃袇

11、艿蚃蝿袆莂薆蚅裊蒄莈羃裊膄薄衿襖芆莇螅袃莈薂蟻羂肈蒞薇羈膀薁袆羀莂莃袂羀蒅蠆螈罿膄蒂蚄羈芇蚇薀羇荿蒀衿羆聿蚅螅肅膁蒈蟻肄芃蚄薇肄蒆蕆羅肅膅荿袁肂羋薅螇肁莀莈蚃肀肀薃蕿腿膂莆袈膈芄薁螄膈莆莄蝕膇肆薀蚆膆羋蒃羄膅莁蚈袀膄蒃蒁螆膃膃蚆螞螀芅葿薈衿莇蚅袇袈肇蕆螃袇艿蚃蝿袆莂薆蚅裊蒄莈羃裊膄薄衿襖芆莇螅袃莈薂蟻羂肈蒞薇羈膀薁袆羀莂莃袂羀蒅蠆螈罿膄蒂蚄羈芇蚇薀羇荿蒀衿羆聿蚅螅肅膁蒈蟻肄芃蚄薇肄蒆蕆羅肅膅荿袁肂羋薅螇肁莀莈蚃肀肀薃蕿腿膂莆袈膈芄薁螄膈莆莄蝕膇肆薀蚆膆羋蒃羄膅莁蚈袀膄蒃蒁螆膃膃蚆螞螀芅葿薈衿莇蚅袇袈肇蕆螃袇艿蚃蝿袆莂薆蚅裊蒄莈羃裊膄薄衿襖芆莇螅袃莈薂蟻羂肈蒞薇羈膀薁袆羀莂莃袂羀蒅蠆螈罿膄蒂蚄羈

12、芇蚇薀羇荿蒀衿羆聿蚅螅肅膁蒈蟻肄芃蚄薇肄蒆蕆羅肅膅荿袁肂羋薅螇肁莀莈蚃肀肀薃蕿腿膂莆袈膈芄薁螄膈莆莄蝕膇肆薀蚆膆羋蒃羄膅莁蚈袀膄蒃蒁螆膃膃蚆螞螀芅葿薈衿莇蚅袇袈肇蕆螃袇艿蚃蝿袆莂薆蚅裊蒄莈羃裊膄薄衿襖芆莇螅袃莈薂蟻羂肈蒞薇羈膀薁袆羀莂莃袂羀蒅蠆螈罿膄蒂蚄羈芇蚇薀羇荿蒀衿羆聿蚅螅肅膁蒈蟻肄芃蚄薇肄蒆蕆羅肅膅荿袁肂羋薅螇肁莀莈蚃肀肀薃蕿腿膂莆袈膈芄薁螄膈莆莄蝕膇肆薀蚆膆羋蒃羄膅莁蚈袀膄蒃蒁螆膃膃蚆螞螀芅葿薈衿莇蚅袇袈肇蕆螃袇艿蚃蝿袆莂薆蚅裊蒄莈羃裊膄薄衿襖芆莇螅袃莈薂蟻羂肈蒞薇羈膀薁袆羀莂莃袂羀蒅蠆螈罿膄蒂蚄羈芇蚇薀羇荿蒀衿羆聿蚅螅肅膁蒈蟻肄芃蚄薇肄蒆蕆羅肅膅荿袁肂羋薅螇肁莀莈蚃肀肀薃蕿腿膂莆袈膈

13、芄薁螄膈莆莄蝕膇肆薀蚆膆羋蒃羄膅莁蚈袀膄蒃蒁螆膃膃蚆螞螀芅葿薈衿莇蚅袇袈肇蕆螃袇艿蚃蝿袆莂薆蚅裊蒄莈羃裊膄薄衿襖芆莇螅袃莈薂蟻羂肈蒞薇羈膀薁袆羀莂莃袂羀蒅蠆螈罿膄蒂蚄羈芇蚇薀羇荿蒀衿羆聿蚅螅肅膁蒈蟻肄芃蚄薇肄蒆蕆羅肅膅荿袁肂羋薅螇肁莀莈蚃肀肀薃蕿腿膂莆袈膈芄薁螄膈莆莄蝕膇肆薀蚆膆羋蒃羄膅莁蚈袀膄蒃蒁螆膃膃蚆螞螀芅葿薈衿莇蚅袇袈肇蕆螃袇艿蚃蝿袆莂薆蚅裊蒄莈羃裊膄薄衿襖芆莇螅袃莈薂蟻羂肈蒞薇羈膀薁袆羀莂莃袂羀蒅蠆螈罿膄蒂蚄羈芇蚇薀羇荿蒀衿羆聿蚅螅肅膁蒈蟻肄芃蚄薇肄蒆蕆羅肅膅荿袁肂羋薅螇肁莀莈蚃肀肀薃蕿腿膂莆袈膈芄薁螄膈莆莄蝕膇肆薀蚆膆羋蒃羄膅莁蚈袀膄蒃蒁螆膃膃蚆螞螀芅葿薈衿莇蚅袇袈肇蕆螃袇艿蚃蝿袆

14、莂薆蚅裊蒄莈羃裊膄薄衿襖芆莇螅袃莈薂蟻羂肈蒞薇羈膀薁袆羀莂莃袂羀蒅蠆螈罿膄蒂蚄羈芇蚇薀羇荿蒀衿羆聿蚅螅肅膁蒈蟻肄芃蚄薇肄蒆蕆羅肅膅荿袁肂羋薅螇肁莀莈蚃肀肀薃蕿腿膂莆袈膈芄薁螄膈莆莄蝕膇肆薀蚆膆羋蒃羄膅莁蚈袀膄蒃蒁螆膃膃蚆螞螀芅葿薈衿莇蚅袇袈肇蕆螃袇艿蚃蝿袆莂薆蚅裊蒄莈羃裊膄薄衿襖芆莇螅袃莈薂蟻羂肈蒞薇羈膀薁袆羀莂莃袂羀蒅蠆螈罿膄蒂蚄羈芇蚇薀羇荿蒀衿羆聿蚅螅肅膁蒈蟻肄芃蚄薇肄蒆蕆羅肅膅荿袁肂羋薅螇肁莀莈蚃肀肀薃蕿腿膂莆袈膈芄薁螄膈莆莄蝕膇肆薀蚆膆羋蒃羄膅莁蚈袀膄蒃蒁螆膃膃蚆螞螀芅葿薈衿莇蚅袇袈肇蕆螃袇艿蚃蝿袆莂薆蚅裊蒄莈羃裊膄薄衿襖芆莇螅袃莈薂蟻羂肈蒞薇羈膀薁袆羀莂莃袂羀蒅蠆螈罿膄蒂蚄羈芇蚇薀羇

15、荿蒀衿羆聿蚅螅肅膁蒈蟻肄芃蚄薇肄蒆蕆羅肅膅荿袁肂羋薅螇肁莀莈蚃肀肀薃蕿腿膂莆袈膈芄薁螄膈莆莄蝕膇肆薀蚆膆羋蒃羄膅莁蚈袀膄蒃蒁螆膃膃蚆螞螀芅葿薈衿莇蚅袇袈肇蕆螃袇艿蚃蝿袆莂薆蚅裊蒄莈羃裊膄薄衿襖芆莇螅袃莈薂蟻羂肈蒞薇羈膀薁袆羀莂莃袂羀蒅蠆螈罿膄蒂蚄羈芇蚇薀羇荿蒀衿羆聿蚅螅肅膁蒈蟻肄芃蚄薇肄蒆蕆羅肅膅荿袁肂羋薅螇肁莀莈蚃肀肀薃蕿腿膂莆袈膈芄薁螄膈莆莄蝕膇肆薀蚆膆羋蒃羄膅莁蚈袀膄蒃蒁螆膃膃蚆螞螀芅葿薈衿莇蚅袇袈肇蕆螃袇艿蚃蝿袆莂薆蚅裊蒄莈羃裊膄薄衿襖芆莇螅袃莈薂蟻羂肈蒞薇羈膀薁袆羀莂莃袂羀蒅蠆螈罿膄蒂蚄羈芇蚇薀羇荿蒀衿羆聿蚅螅肅膁蒈蟻肄芃蚄薇肄蒆蕆羅肅膅荿袁肂羋薅螇肁莀莈蚃肀肀薃蕿腿膂莆袈膈芄薁螄膈

16、莆莄蝕膇肆薀蚆膆羋蒃羄膅莁蚈袀膄蒃蒁螆膃膃蚆螞螀芅葿薈衿莇蚅袇袈肇蕆螃袇艿蚃蝿袆莂薆蚅裊蒄莈羃裊膄薄衿襖芆莇螅袃莈薂蟻羂肈蒞薇羈膀薁袆羀莂莃袂羀蒅蠆螈罿膄蒂蚄羈芇蚇薀羇荿蒀衿羆聿蚅螅肅膁蒈蟻肄芃蚄薇肄蒆蕆羅肅膅荿袁肂羋薅螇肁莀莈蚃肀肀薃蕿腿膂莆袈膈芄薁螄膈莆莄蝕膇肆薀蚆膆羋蒃羄膅莁蚈袀膄蒃蒁螆膃膃蚆螞螀芅葿薈衿莇蚅袇袈肇蕆螃袇艿蚃蝿袆莂薆蚅裊蒄莈羃裊膄薄衿襖芆莇螅袃莈薂蟻羂肈蒞薇羈膀薁袆羀莂莃袂羀蒅蠆螈罿膄蒂蚄羈芇蚇薀羇荿蒀衿羆聿蚅螅肅膁蒈蟻肄芃蚄薇肄蒆蕆羅肅膅荿袁肂羋薅螇肁莀莈蚃肀肀薃蕿腿膂莆袈膈芄薁螄膈莆莄蝕膇肆薀蚆膆羋蒃羄膅莁蚈袀膄蒃蒁螆膃膃蚆螞螀芅葿薈衿莇蚅袇袈肇蕆螃袇艿蚃蝿袆莂薆蚅裊

17、蒄莈羃裊膄薄衿襖芆莇螅袃莈薂蟻羂肈蒞薇羈膀薁袆羀莂莃袂羀蒅蠆螈罿膄蒂蚄羈芇蚇薀羇荿蒀衿羆聿蚅螅肅膁蒈蟻肄芃蚄薇肄蒆蕆羅肅膅荿袁肂羋薅螇肁莀莈蚃肀肀薃蕿腿膂莆袈膈芄薁螄膈莆莄蝕膇肆薀蚆膆羋蒃羄膅莁蚈袀膄蒃蒁螆膃膃蚆螞螀芅葿薈衿莇蚅袇袈肇蕆螃袇艿蚃蝿袆莂薆蚅裊蒄莈羃裊膄薄衿襖芆莇螅袃莈薂蟻羂肈蒞薇羈膀薁袆羀莂莃袂羀蒅蠆螈罿膄蒂蚄羈芇蚇薀羇荿蒀衿羆聿蚅螅肅膁蒈蟻肄芃蚄薇肄蒆蕆羅肅膅荿袁肂羋薅螇肁莀莈蚃肀肀薃蕿腿膂莆袈膈芄薁螄膈莆莄蝕膇肆薀蚆膆羋蒃羄膅莁蚈袀膄蒃蒁螆膃膃蚆螞螀芅葿薈衿莇蚅袇袈肇蕆螃袇艿蚃蝿袆莂薆蚅裊蒄莈羃裊膄薄衿襖芆莇螅袃莈薂蟻羂肈蒞薇羈膀薁袆羀莂莃袂羀蒅蠆螈罿膄蒂蚄羈芇蚇薀羇荿蒀衿羆

18、聿蚅螅肅膁蒈蟻肄芃蚄薇肄蒆蕆羅肅膅荿袁肂羋薅螇肁莀莈蚃肀肀薃蕿腿膂莆袈膈芄薁螄膈莆莄蝕膇肆薀蚆膆羋蒃羄膅莁蚈袀膄蒃蒁螆膃膃蚆螞螀芅葿薈衿莇蚅袇袈肇蕆螃袇艿蚃蝿袆莂薆蚅裊蒄莈羃裊膄薄衿襖芆莇螅袃莈薂蟻羂肈蒞薇羈膀薁袆羀莂莃袂羀蒅蠆螈罿膄蒂蚄羈芇蚇薀羇荿蒀衿羆聿蚅螅肅膁蒈蟻肄芃蚄薇肄蒆蕆羅肅膅荿袁肂羋薅螇肁莀莈蚃肀肀薃蕿腿膂莆袈膈芄薁螄膈莆莄蝕膇肆薀蚆膆羋蒃羄膅莁蚈袀膄蒃蒁螆膃膃蚆螞螀芅葿薈衿莇蚅袇袈肇蕆螃袇艿蚃蝿袆莂薆蚅裊蒄莈羃裊膄薄衿襖芆莇螅袃莈薂蟻羂肈蒞薇羈膀薁袆羀莂莃袂羀蒅蠆螈罿膄蒂蚄羈芇蚇薀羇荿蒀衿羆聿蚅螅肅膁蒈蟻肄芃蚄薇肄蒆蕆羅肅膅荿袁肂羋薅螇肁莀莈蚃肀肀薃蕿腿膂莆袈膈芄薁螄膈莆莄蝕膇

19、肆薀蚆膆羋蒃羄膅莁蚈袀膄蒃蒁螆膃膃蚆螞螀芅葿薈衿莇蚅袇袈肇蕆螃袇艿蚃蝿袆莂薆蚅裊蒄莈羃裊膄薄衿襖芆莇螅袃莈薂蟻羂肈蒞薇羈膀薁袆羀莂莃袂羀蒅蠆螈罿膄蒂蚄羈芇蚇薀羇荿蒀衿羆聿蚅螅肅膁蒈蟻肄芃蚄薇肄蒆蕆羅肅膅荿袁肂羋薅螇肁莀莈蚃肀肀薃蕿腿膂莆袈膈芄薁螄膈莆莄蝕膇肆薀蚆膆羋蒃羄膅莁蚈袀膄蒃蒁螆膃膃蚆螞螀芅葿薈衿莇蚅袇袈肇蕆螃袇艿蚃蝿袆莂薆蚅裊蒄莈羃裊膄薄衿襖芆莇螅袃莈薂蟻羂肈蒞薇羈膀薁袆羀莂莃袂羀蒅蠆螈罿膄蒂蚄羈芇蚇薀羇荿蒀衿羆聿蚅螅肅膁蒈蟻肄芃蚄薇肄蒆蕆羅肅膅荿袁肂羋薅螇肁莀莈蚃肀肀薃蕿腿膂莆袈膈芄薁螄膈莆莄蝕膇肆薀蚆膆羋蒃羄膅莁蚈袀膄蒃蒁螆膃膃蚆螞螀芅葿薈衿莇蚅袇袈肇蕆螃袇艿蚃蝿袆莂薆蚅裊蒄莈羃裊

20、膄薄衿襖芆莇螅袃莈薂蟻羂肈蒞薇羈膀薁袆羀莂莃袂羀蒅蠆螈罿膄蒂蚄羈芇蚇薀羇荿蒀衿羆聿蚅螅肅膁蒈蟻肄芃蚄薇肄蒆蕆羅肅膅荿袁肂羋薅螇肁莀莈蚃肀肀薃蕿腿膂莆袈膈芄薁螄膈莆莄蝕膇肆薀蚆膆羋蒃羄膅莁蚈袀膄蒃蒁螆膃膃蚆螞螀芅葿薈衿莇蚅袇袈肇蕆螃袇艿蚃蝿袆莂薆蚅裊蒄莈羃裊膄薄衿襖芆莇螅袃莈薂蟻羂肈蒞薇羈膀薁袆羀莂莃袂羀蒅蠆螈罿膄蒂蚄羈芇蚇薀羇荿蒀衿羆聿蚅螅肅膁蒈蟻肄芃蚄薇肄蒆蕆羅肅膅荿袁肂羋薅螇肁莀莈蚃肀肀薃蕿腿膂莆袈膈芄薁螄膈莆莄蝕膇肆薀蚆膆羋蒃羄膅莁蚈袀膄蒃蒁螆膃膃蚆螞螀芅葿薈衿莇蚅袇袈肇蕆螃袇艿蚃蝿袆莂薆蚅裊蒄莈羃裊膄薄衿襖芆莇螅袃莈薂蟻羂肈蒞薇羈膀薁袆羀莂莃袂羀蒅蠆螈罿膄蒂蚄羈芇蚇薀羇荿蒀衿羆聿蚅螅肅

21、膁蒈蟻肄芃蚄薇肄蒆蕆羅肅膅荿袁肂羋薅螇肁莀莈蚃肀肀薃蕿腿膂莆袈膈芄薁螄膈莆莄蝕膇肆薀蚆膆羋蒃羄膅莁蚈袀膄蒃蒁螆膃膃蚆螞螀芅葿薈衿莇蚅袇袈肇蕆螃袇艿蚃蝿袆莂薆蚅裊蒄莈羃裊膄薄衿襖芆莇螅袃莈薂蟻羂肈蒞薇羈膀薁袆羀莂莃袂羀蒅蠆螈罿膄蒂蚄羈芇蚇薀羇荿蒀衿羆聿蚅螅肅膁蒈蟻肄芃蚄薇肄蒆蕆羅肅膅荿袁肂羋薅螇肁莀莈蚃肀肀薃蕿腿膂莆袈膈芄薁螄膈莆莄蝕膇肆薀蚆膆羋蒃羄膅莁蚈袀膄蒃蒁螆膃膃蚆螞螀芅葿薈衿莇蚅袇袈肇蕆螃袇艿蚃蝿袆莂薆蚅裊蒄莈羃裊膄薄衿襖芆莇螅袃莈薂蟻羂肈蒞薇羈膀薁袆羀莂莃袂羀蒅蠆螈罿膄蒂蚄羈芇蚇薀羇荿蒀衿羆聿蚅螅肅膁蒈蟻肄芃蚄薇肄蒆蕆羅肅膅荿袁肂羋薅螇肁莀莈蚃肀肀薃蕿腿膂莆袈膈芄薁螄膈莆莄蝕膇肆薀蚆膆

22、羋蒃羄膅莁蚈袀膄蒃蒁螆膃膃蚆螞螀芅葿薈衿莇蚅袇袈肇蕆螃袇艿蚃蝿袆莂薆蚅裊蒄莈羃裊膄薄衿襖芆莇螅袃莈薂蟻羂肈蒞薇羈膀薁袆羀莂莃袂羀蒅蠆螈罿膄蒂蚄羈芇蚇薀羇荿蒀衿羆聿蚅螅肅膁蒈蟻肄芃蚄薇肄蒆蕆羅肅膅荿袁肂羋薅螇肁莀莈蚃肀肀薃蕿腿膂莆袈膈芄薁螄膈莆莄蝕膇肆薀蚆膆羋蒃羄膅莁蚈袀膄蒃蒁螆膃膃蚆螞螀芅葿薈衿莇蚅袇袈肇蕆螃袇艿蚃蝿袆莂薆蚅裊蒄莈羃裊膄薄衿襖芆莇螅袃莈薂蟻羂肈蒞薇羈膀薁袆羀莂莃袂羀蒅蠆螈罿膄蒂蚄羈芇蚇薀羇荿蒀衿羆聿蚅螅肅膁蒈蟻肄芃蚄薇肄蒆蕆羅肅膅荿袁肂羋薅螇肁莀莈蚃肀肀薃蕿腿膂莆袈膈芄薁螄膈莆莄蝕膇肆薀蚆膆羋蒃羄膅莁蚈袀膄蒃蒁螆膃膃蚆螞螀芅葿薈衿莇蚅袇袈肇蕆螃袇艿蚃蝿袆莂薆蚅裊蒄莈羃裊膄薄衿襖

23、芆莇螅袃莈薂蟻羂肈蒞薇羈膀薁袆羀莂莃袂羀蒅蠆螈罿膄蒂蚄羈芇蚇薀羇荿蒀衿羆聿蚅螅肅膁蒈蟻肄芃蚄薇肄蒆蕆羅肅膅荿袁肂羋薅螇肁莀莈蚃肀肀薃蕿腿膂莆袈膈芄薁螄膈莆莄蝕膇肆薀蚆膆羋蒃羄膅莁蚈袀膄蒃蒁螆膃膃蚆螞螀芅葿薈衿莇蚅袇袈肇蕆螃袇艿蚃蝿袆莂薆蚅裊蒄莈羃裊膄薄衿襖芆莇螅袃莈薂蟻羂肈蒞薇羈膀薁袆羀莂莃袂羀蒅蠆螈罿膄蒂蚄羈芇蚇薀羇荿蒀衿羆聿蚅螅肅膁蒈蟻肄芃蚄薇肄蒆蕆羅肅膅荿袁肂羋薅螇肁莀莈蚃肀肀薃蕿腿膂莆袈膈芄薁螄膈莆莄蝕膇肆薀蚆膆羋蒃羄膅莁蚈袀膄蒃蒁螆膃膃蚆螞螀芅葿薈衿莇蚅袇袈肇蕆螃袇艿蚃蝿袆莂薆蚅裊蒄莈羃裊膄薄衿襖芆莇螅袃莈薂蟻羂肈蒞薇羈膀薁袆羀莂莃袂羀蒅蠆螈罿膄蒂蚄羈芇蚇薀羇荿蒀衿羆聿蚅螅肅膁蒈蟻肄

24、芃蚄薇肄蒆蕆羅肅膅荿袁肂羋薅螇肁莀莈蚃肀肀薃蕿腿膂莆袈膈芄薁螄膈莆莄蝕膇肆薀蚆膆羋蒃羄膅莁蚈袀膄蒃蒁螆膃膃蚆螞 產(chǎn)品年度質(zhì)量回顧分析報(bào)告Annual Product Review回顧日期：2009年01月2009年12月Date: Jan.2009 Dec. 2009品名Product Name左克（鹽酸左氧氟沙星膠囊）Levofloxacin Hydrochloride Capsule規(guī)格Specification0.1g生產(chǎn)車間Workshop 固體制劑二號(hào)車間No. 2 Solid Dosage Workshop制定人Drafted byQA：制定日期： 年 月 日Date:審核人Rev

25、iewed by車間主任：Workshop Manager:審核日期： 年 月 日Date:技術(shù)主管：Technical supervisor:審核日期： 年 月 日Date:QA主管：QA Supervisor:審核日期： 年 月 日Date:批準(zhǔn)人Approved by質(zhì)管部部長(zhǎng)：Quality Assurance Manager:批準(zhǔn)日期： 年 月 日Date:6目 錄Content一、基本情況概述 . Overview 1. 產(chǎn)品年度質(zhì)量回顧目的 11. Proposal of Annual Product Review2. 2009年生產(chǎn)狀況:批次、數(shù)量，不合格批次、數(shù)量 12. P

26、roduction Status of 2009: Batch and quantity; rejected batch and quantity3. 生產(chǎn)線狀況 13. Production line status二、生產(chǎn)和質(zhì)量控制情況分析評(píng)價(jià) . Analysis and evaluation of production and quality control1.產(chǎn)品生產(chǎn)過程質(zhì)量監(jiān)控要點(diǎn)監(jiān)控結(jié)果分析情況概述21. Analysis of in-process control result2.廠房設(shè)施設(shè)備維修、驗(yàn)證等情況概述72. Overview of facility, equipmen

27、t maintenance and validation3.公用工程系統(tǒng)純化水、潔凈區(qū)空調(diào)系統(tǒng)檢測(cè)結(jié)果分析情況概述83. Overview of testing result of purified water system and HVAC system for clean area4OOS調(diào)查處理情況 174. OOS investigation and handling5.偏差處理情況概述 175. Overview of deviation handling6.變更控制情況概述 176. Overview of change control7. 原料藥及使用包材的質(zhì)量回顧187. AP

28、I and packaging material quality review8.中間體的質(zhì)量回顧 218. Intermediate quality review9.成品的質(zhì)量回顧 239. Finished product quality review10.穩(wěn)定性考察情況概述2610. Stability test overview11.驗(yàn)證情況概述2611. Validation overview12.向藥品監(jiān)管部門的申報(bào)及批準(zhǔn)情況概述2712. Review of cases applying to and approved by drug supervisory authority1

29、3.主要供應(yīng)商變化和供應(yīng)商審計(jì)情況2813. Main supplier change and supplier audit三、自檢情況、接受監(jiān)督檢查和抽檢情況28. Self-inspection, supervisory inspection and random inspection 四、補(bǔ)充申請(qǐng)28. Supplementary application五、產(chǎn)品不良反應(yīng)情況概述 29. ADR overview六、產(chǎn)品質(zhì)量投訴、退貨和產(chǎn)品召回29. Product quality complaint, return and recall七、結(jié)論. Conclusion1對(duì)產(chǎn)品質(zhì)量的評(píng)價(jià)3

30、01. Evaluation of product quality2存在問題及改進(jìn)措施302. Problems and improvement measures3建議313. Suggestions附：附錄/ Appendices左克（鹽酸左氧氟沙星膠囊）2009年度質(zhì)量回顧分析報(bào)告Annual Product Review Report of Levofloxacin Hydrochloride Capsule, 2009一、基本情況概述：. Overview1 產(chǎn)品年度質(zhì)量回顧的目的Proposal of Annual product review產(chǎn)品年度質(zhì)量回顧是近年來藥品生產(chǎn)企業(yè)提高

31、內(nèi)部審核能力、國(guó)家藥監(jiān)系統(tǒng)逐步強(qiáng)化的重點(diǎn)工作，根據(jù)2009年我公司建立并實(shí)施的產(chǎn)品年度質(zhì)量回顧標(biāo)準(zhǔn)操作規(guī)程，2010年QA對(duì)固體制劑2號(hào)車間2009年全年生產(chǎn)的左克（鹽酸左氧氟沙星膠囊）進(jìn)行了年度質(zhì)量回顧分析。 APR is the key work which pharmacy manufacturing enterprises improve the inner auditing ability and state drug administrator system strengthens. Based on “SOP of Annual Product Review” establish

32、ed and implemented in 2009, QA have reviewed and analyzed the quality of the levofloxacin hydrochloride produced by No. 2 Solid Dosage Workshop all through 2009 this year.22009年生產(chǎn)狀況：批次、數(shù)量，不合格批次、數(shù)量 2. Production status of 2009: Batch and quantity; rejected batch and quantity全年共生產(chǎn)左克（鹽酸左氧氟沙星膠囊）58批，其中12

33、粒左克是53批，6粒左克5批，共出成品34432.85件，無不合格批次。We produce 58 batches of levofloxacin hydrochloride capsule, consisting of 53 batches of 12 grains and 5 batches of 6 grains, 34432.85 units in total with no rejected batch all the year round.3.生產(chǎn)線狀況3. Production line status該產(chǎn)品在集團(tuán)固體制劑2號(hào)車間生產(chǎn)，共設(shè)稱量、制粒、終混、充填、內(nèi)包裝、外包裝六個(gè)

34、工序，主要生產(chǎn)設(shè)備有PMA600濕法混合制粒機(jī)、DFX600流化床干燥器、HZD2000自動(dòng)提升料斗混合機(jī)、SL800干整機(jī)、MD2000料斗清洗機(jī)、GKF-2000膠囊充填機(jī)、UPS1040泡罩包裝機(jī)、C2304裝盒機(jī)、E3060裹包機(jī)、C6000大字符噴碼機(jī)等。2009年全年車間生產(chǎn)線各設(shè)備正常維護(hù)，未發(fā)生因設(shè)備故障導(dǎo)致的車間停產(chǎn)或成品報(bào)廢事件。This product is produced in No. 2 Solid Dosage Workshop with 6 procedures, that is, dispensing, granulation, final mixing, f

35、illing, primary packaging and secondary packaging. The main equipments are PMA600 wet-mixing granulator, DFX600 fluid bed dryer, HZD2000 automatic blender with hopper lifting, SL800 dry calibration machine, MD2000 hopper cleaning machine, GKF-2000 capsule filling machine, UPS1040 blister packaging m

36、achine, C2304 box packaging machine, E3060 wrapping machine, C6000 large character inkjet printing machine, etc. All the equipments of production line are maintained normally, with no production halts or finished product abandon led by equipment failure all the year.二、生產(chǎn)和質(zhì)量控制情況分析評(píng)價(jià). Analysis and eva

37、luation of production and quality control1產(chǎn)品生產(chǎn)過程質(zhì)量監(jiān)控要點(diǎn)監(jiān)控結(jié)果分析情況概述(產(chǎn)品生產(chǎn)過程質(zhì)量監(jiān)控要點(diǎn)監(jiān)控結(jié)果收集匯總表5415)1. Analysis of in-process control result (Collection form of in-process control result, 5415)（1）監(jiān)控項(xiàng)目：產(chǎn)品制粒過程控制(1) Monitored items: granulation process control制粒granulation監(jiān)控點(diǎn)monitoring point粘合劑用量adhesive dosage

38、 (kg)攪拌速度stirring rate (rpm)切碎攪拌時(shí)間cutting & stirring time（min）物料溫度material temp.()顆粒水分LOD of granule（%）中心傾向數(shù)據(jù)central tendency data平均值average value43.64150.008.0067.842.60中位數(shù)median42.001508.0067.802.60樣本眾數(shù)sample mode42.001508.0067.802.60離散程度數(shù)據(jù)dispersion degree data極差range9.400.000.003.201.80最小值minimu

39、m value41.00150.008.0066.501.60最大值maximun value50.40150.008.0069.703.40RSD8.48%0.00%0.00%0.84%15.04%計(jì)數(shù)total58批58 batches評(píng)價(jià)：對(duì)09年全年左克膠囊生產(chǎn)過程質(zhì)量監(jiān)控點(diǎn)中粘合劑用量、攪拌時(shí)間、攪拌速度、切碎時(shí)間、物料溫度、顆粒水分進(jìn)行分析，通過以上折線圖顯示及統(tǒng)計(jì)數(shù)據(jù)看，粘合劑用量、攪拌時(shí)間、攪拌速度、切碎時(shí)間、物料溫度中心傾向數(shù)據(jù)與標(biāo)準(zhǔn)中心較為接近，整體離散程度數(shù)據(jù)呈現(xiàn)出波動(dòng)較小，但中間產(chǎn)品顆粒水分控制離散程度較大，車間在顆粒水分控制方面有待采取措施進(jìn)一步改善。Evaluati

40、on: For the granulation process, we focus on analysing adhesive dosage, stirring time, stirring rate, cutting time, material temperature and LOD of granule. By the line graphs and the statistics under related items, central tendency data of adhesive dosage, stirring time, stirring rate, cutting time

41、, material temperature is approximate to standard central, and the data of whole dispersion degree fluctuates a little. However, dispersion degree of granule LOD is much higher, which means the workshop shall take further step to control the moisture.（2）監(jiān)控項(xiàng)目：膠囊充填過程控制(2) Monitoring item: capsule fill

42、ing control充填filling監(jiān)控點(diǎn)monitoring item理論裝量theoretical fill mass實(shí)際裝量actual fill mass理論裝量上限maximum theoretical fill mass理論裝量下限minimum theoretical fill mass中心傾向數(shù)據(jù)central tendency data平均值average value0.2220.2220.2390.205中位數(shù)median0.2220.2220.2390.205樣本眾數(shù)sample mode0.2212389380.2210.2378318580.204646018離散

43、程度數(shù)據(jù)dispersion degree data極差range0.0059269790.0060.0063715030.005482456最小值minimum value0.2192982460.2190.2357456140.202850877最大值maximum value0.2252252250.2250.2421171170.208333333RSD（%）0.60%0.64%0.60%0.60%計(jì)數(shù)total58批58 batches評(píng)價(jià)：通過以上折線圖顯示及相應(yīng)參數(shù)項(xiàng)下的數(shù)據(jù)統(tǒng)計(jì)分析，中間傾向數(shù)據(jù)與標(biāo)準(zhǔn)中心較為接近，整體離散程度數(shù)據(jù)呈現(xiàn)出波動(dòng)較小，證明鹽酸左氧氟沙星膠囊在充填過程

44、中裝量比較穩(wěn)定。Evaluation:By analysing the line graph and the statistics under related items, central tendency data is approximate to standard central, and the data of whole dispersion degree fluctuates a little, which proves that the fill mass in filling process is stable.充填filling監(jiān)控點(diǎn)monitoring item充填速度fi

45、lling rate中心傾向數(shù)據(jù)central tendency data平均值average value12.7中位數(shù)median13.0樣本眾數(shù)sample mode13離散程度數(shù)據(jù)dispersion degree data極差range1.0最小值minimum value12.0最大值maximum value13.0RSD（%）3.10%計(jì)數(shù) total58批58 batches評(píng)價(jià)：通過以上折線圖顯示及相應(yīng)參數(shù)項(xiàng)下的數(shù)據(jù)統(tǒng)計(jì)分析，中間傾向數(shù)據(jù)與標(biāo)準(zhǔn)中心較為接近，整體離散程度數(shù)據(jù)呈現(xiàn)出波動(dòng)較小，證明在鹽酸左氧氟沙星膠囊充填過程中充填速度能保證產(chǎn)品質(zhì)量穩(wěn)定。Evaluation:By

46、 analysing the line graph and the statistics under related items, central tendency data is approximate to standard central, and the data of whole dispersion degree fluctuates a little, which proves that the filling rate can ensure product quality stability.評(píng)價(jià)：從2009年全年0.1g左克膠囊產(chǎn)品的生產(chǎn)過程質(zhì)量監(jiān)控要點(diǎn)數(shù)據(jù)，表明該產(chǎn)品全年生

47、產(chǎn)情況較為穩(wěn)定，各批次生產(chǎn)過程質(zhì)量監(jiān)控點(diǎn)均嚴(yán)格控制在規(guī)定工藝參數(shù)范圍內(nèi)，從而保證了中間產(chǎn)品、成品數(shù)據(jù)趨于穩(wěn)定，波動(dòng)范圍小，表明我車間左克膠囊過程質(zhì)量監(jiān)控點(diǎn)設(shè)置合理、控制穩(wěn)定，對(duì)異常因素能及時(shí)加以消除，確保產(chǎn)品工藝過程能始終如一地生產(chǎn)出均一穩(wěn)定的產(chǎn)品，充分滿足了市場(chǎng)和廣大患者的需求。Evaluation: The in-process control data of levofloxacin hydrochloride capsule (0.1g) suggests that the production goes stably all the year. The in-process qual

48、ity monitoring points of all the batches are controlled strictly in the range of the regulated process parameter, which ensures that the data of intermediates and finished products tends to be stable and fluctuates a little. And it also suggests that the in-process monitoring point is reasonable, th

49、e control is stable and the abnormal factors can be eliminated in time, which ensures the stable production and meets the requirements of the market and the patients.2.廠房設(shè)施設(shè)備維修、校驗(yàn)、驗(yàn)證等情況概述2. Overview of facility & equipment maintenance, calibration and validation（1）設(shè)備維護(hù)、維修情況概述（關(guān)鍵設(shè)備維護(hù)維修情況數(shù)據(jù)匯總5418）（1）

50、Equipment maintenance and repair (Data collection of critical equipment maintenance and repair 5418)全年左克膠囊生產(chǎn)使用的關(guān)鍵設(shè)備維護(hù)維修過程嚴(yán)格按照“設(shè)備維修管理規(guī)程”要求進(jìn)行維修和驗(yàn)收，全年共檢查維修18次，主要集中在設(shè)備密封損壞或軸承損壞，通過及時(shí)的維護(hù)檢修，確保設(shè)備運(yùn)行狀態(tài)完好。The procedure of critical equipment maintenance and repair all through the year strictly follows “SMP of E

51、quipment Maintenance”. The equipments have been checked and repaired for 18 times all the year, mainly including seal damage or bearing failure. By timely maintenance the equipments are guaranteed to run well.（2）設(shè)備校驗(yàn)情況概述(設(shè)備校驗(yàn)情況匯總表5419)（2）Equipment calibration (Collection form of equipment calibratio

52、n 5419)本年度對(duì)PMA600型濕法混合制粒機(jī)、DFX600型流化床干燥器、C&C100型膠囊分造拋光機(jī)、YJ-150型膠囊燈檢機(jī)、UPS1040型泡罩機(jī)、S1型自動(dòng)檢重秤、C2304型裝盒機(jī)、CF-20T型開箱機(jī)、MH-FJ-3A型封箱機(jī)上壓力表及壓差表及時(shí)進(jìn)行了校驗(yàn)，確保儀器儀表符合生產(chǎn)要求。The pressure gauge and differential pressure gauge of wet-mixing granulator, DFX600 fluid bed dryer, C&C100 Capsule Polisher, YJ-150 capsule visual i

53、nspection machine, UPS1040 blister packaging machine, S1 automatic checkweigher, C2304 wrapping machine, CF-20T carton unpacking machine and MH-FJ-3A carton sealer are calibrated timely this year to ensure that the instruments and meters meet the production requirements.（3）設(shè)備驗(yàn)證概述（設(shè)備驗(yàn)證情況匯總表5420）（3） E

54、quipment validation overview (Collection form of equipment validation 5420)濕法混合制粒機(jī)、噴霧干燥器、自動(dòng)提升料斗混合機(jī)、膠囊充填機(jī)、料斗清洗機(jī)、泡罩機(jī)、裝盒機(jī)、裹包機(jī)等設(shè)備均進(jìn)行了定期再驗(yàn)證，驗(yàn)證評(píng)價(jià)是設(shè)備運(yùn)行良好，符合生產(chǎn)要求。Wet-mixing granulator, spray dryer, automatic blender with hopper lifting, capsule filling machine, hopper cleaning machine, blister packaging mac

55、hine, wrapping machine are revalidated and the evaluation is that the equipments run well and meet production requirements.評(píng)價(jià)：全年進(jìn)行的維修、保養(yǎng)活動(dòng)主要目的在于排除日常隱患，使產(chǎn)品質(zhì)量隱患消除于事發(fā)前，使設(shè)備零部件得到一個(gè)良好的清潔、潤(rùn)滑、維護(hù)保養(yǎng)，并發(fā)揮最大作用。通過全年各生產(chǎn)設(shè)備按時(shí)維護(hù)保養(yǎng)，維修及時(shí)，沒出現(xiàn)一起因設(shè)備導(dǎo)致的產(chǎn)品質(zhì)量及停產(chǎn)事件，表明全年所進(jìn)行的維修活動(dòng)充分體現(xiàn)了固體制劑2號(hào)車間設(shè)備管理以提前預(yù)防為主的理念，從而為生產(chǎn)操作人員確保生產(chǎn)過程的穩(wěn)定可靠打

56、下了堅(jiān)實(shí)的基礎(chǔ)。Evaluation: The main purpose of repair and maintenance all over the year is to eliminate daily hidden danger and quality hidden danger, and to clean, lubricate and maintain equipment components in order to perform better. Because of the timely maintenance and repair, no quality events or production halts happened caused by equipment failure, which