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CAPA - johokiko.co.jp

1 .. CAPA . CAPA . C A PA C A PA C A PA . 4 . P D C A C A PA = C h e c k = A c t i o n . =Plan Do =Check . PDCA . C A PA P D C A . C A PA .. C A PA .. C A PA .. 1 CAPA . 03. 3 . CA PA.. C A PA .. = .. C A PA .. 07.. 6 . CA PA.. 15. 10-12 . 3 CAPA .. C A PA C A PA C A PA .. 7 CAPA .. C A PA .. C A PA .. C A PA . C A PA .. C A PA .. 4 C A PA . G M P C A PA C A PA . I S O 9 0 0 1 C A PA G M P . GMP . C A PA .. 17.. CAPA . C A PA 4 . C A PA C A PA .. C A PA .. C A PA .. C A PA .. C A PA .. 20.. C A PA C A PA .. CAPA .. 3 .. 13-16 .. C A PA C A PA .. 22. 17/33.. PDPC .. 17 .. C A PA .. C A PA .. : .. Man,Media,Management, Mathine,Material,Method .. 4 .. 25. 22,23 . CAPA . C A PA .. C A PA .. C A PA .. 4 CAPA.

07 表3 問題の把握のプロセス 大ステップ 小ステップ ca pa 問題の検出 ① 発生してほしくない事象のリストアップ

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Transcription of CAPA - johokiko.co.jp

1 1 .. CAPA . CAPA . C A PA C A PA C A PA . 4 . P D C A C A PA = C h e c k = A c t i o n . =Plan Do =Check . PDCA . C A PA P D C A . C A PA .. C A PA .. C A PA .. 1 CAPA . 03. 3 . CA PA.. C A PA .. = .. C A PA .. 07.. 6 . CA PA.. 15. 10-12 . 3 CAPA .. C A PA C A PA C A PA .. 7 CAPA .. C A PA .. C A PA .. C A PA . C A PA .. C A PA .. 4 C A PA . G M P C A PA C A PA . I S O 9 0 0 1 C A PA G M P . GMP . C A PA .. 17.. CAPA . C A PA 4 . C A PA C A PA .. C A PA .. C A PA .. C A PA .. C A PA .. 20.. C A PA C A PA .. CAPA .. 3 .. 13-16 .. C A PA C A PA .. 22. 17/33.. PDPC .. 17 .. C A PA .. C A PA .. : .. Man,Media,Management, Mathine,Material,Method .. 4 .. 25. 22,23 . CAPA . C A PA .. C A PA .. C A PA .. 4 CAPA.

2 CAPA . 24 . CAPA . C A PA .. 1 .. 2 .. 32.. 3 .. 4 .. FDA CAPA . F DA Wa r n i n g L e t t e r C A PA 4 . C A PA .. 1 .. / .. 33.


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