
įŠēįŊ īŊ įŦŦ3芹 įĄåšåīŧINVALIDATEīŧ
ãįĄåšãĢããã¨ãããã¨ã¯ããĒããŖããã¨ãĢããã¨ãããã¨ã ã
ãčĩˇãããã¨ãčĩˇããĒããŖããã¨ãĢãããåēãįĩæãåēãĒããŖããã¨ãĢãããããã¯æŦæĨįĨãĢããã§ããĒããã¨ãŽã¯ãã ãŖããã ãį§ããĄã¯æ¸éĄãŽä¸ã§ããããæ¯æĨããŖãĻããããįĄåšãã¨ä¸čĄæ¸ãã°ãä¸įã¯ãģããŽå°ãã ãæ¸ãæãããéŊæ§ã¯æļãããæąãã¯ãĒããŖããã¨ãĢãĒãã
ãããĄã°ãããããįĄåšãĢã§ãããŽã¯ãæģãã äēēéã ãæģč ã¯æč°ããĒãã荿ŖãæąããĒããč¨ŧč¨å°ãĢįĢããĒããã ããįããĻããäēēéã¯ãéŊåãŽæĒããã¨ãããæģč ãŽä¸ãĢįŠããįŠãžããæģč ã¯éģãŖãĻãããčč˛ ãã
ã᏿˛ĸãããããĒããŽä¸ãĢããããããããããŽããŽãįŠãžããžãã
ãį§ãįŠããŽã§ã¯ãĒããäŧį¤žãããĒããŽä¸ãĢįŠãŋãĢãããį§ã¯ãã ããŽåąąãå´ŠããĒããããĢãä¸ããããŖã¨æ¯ããã ãã ã
âãâãâ
ãæģå¯ã¯åžŽįįŠãŠãã§ãŽæ°æĨãæåžãĢã˛ã¨ãžãéãããæįĩæĨãĢãŠããŦãšã¯Form 483ãįŊŽããĻããŖããããŽįŖæģč¨ŧčˇĄãŽææãĢã垎įįŠããŧãŋã¤ãŗãã°ãĒããŖãŽčĻŗå¯äēé ãå ããŖãäēé įŽãŽį´ã ãŖãã
ãäŧį¤žã¯æéå ãĢãããŽ483ã¸ãŽå῏ãåēãããæ¯æŖã¨äēé˛ãŽį´æãåŊįļããŽåįãį§ãæ¸ãããæŦįŠãŽäēåŽã ãã§éãĒãã
ãã ããããã§ã¯čļŗããĒããŖãã
ãæ°ãæåžãFDAã¯į§ããĄãŽåįããä¸ååãã¨čŠäžĄãããį´æãããæ¯æŖããéåģãŽããŧãŋã¤ãŗãã°ãĒããŖåéĄãŽæ šåššãĢåąããĻããĒããã¨ãč ãŖãĻãããŽã¯æįļãã§ã¯ãĒãæ šãŽãģãã ãããčĻæãããã¨ãããã¨ã ãŖãããããĻæŖåŧãĒWarning LetterãŽįēčĄãéåãããã
ãããŽéŖįĩĄãæĨãã¨ããä¸åŽ ã¯ããŽčąæãå°åˇããĻ寞įäŧč°ãŽæēãĢä¸Ļãšããäŧč°åޤãĢã¯åˇĨå ´éˇãŽæ˛ŧį°ã¨ãčŖŊé ãåčŗĒãčŦäēãŽč˛Ŧäģģč ããéãéĄã§åē§ãŖãĻããã
ãæéĸã¯ãį§ãäēæŗããã¨ããã ãŖãã
ãããŧãŋã¤ãŗãã°ãĒããŖãĢéĸããįĩįšįãĒæŦ éĨãįšãĢãéåģãŽįĄččŠĻé¨ãĢãããé¸čąčĒŋæģââAP-204ãŽããŽä¸äģļââãĢã¤ããĻãæ¤åēčãŽįąæĨčŠäžĄãčŖŊåæąæãŽå¯čŊæ§ãååãĢæ¤č¨ãããčŠĻé¨įŗģãŽæąæãĢéåŽãããĻãããåčŠĻé¨ãĢããåæ ŧãŽæĄį¨ãį§åĻįãĢæŖåŊåãããĻããĒããis not adequately justified. ããŽä¸čĄãé荺ãåŖ°ãĢåēããĻčĒãã ã¨ããäŧč°åޤãŽįŠēæ°ãéãæ˛ãã ã
ãããã¯ãã¨æ˛ŧį°ãäŊãåŖ°ã§č¨ãŖãããäēåš´åãŽčŠąã ãããäēåš´åãŽãAP-204ãŽã
ãã¯ããã¨ä¸åŽ ãįããã
ãäēåš´åãŽQAč˛Ŧäģģč ã¯čǰã ã
ãčǰããããĢã¯įããĒããŖããįãã¯å ¨åĄãããŖãĻããããã ã
ã᏿˛ĸããã§ããã¨ããããĻčŦäēãŽč˛Ŧäģģč ãč¨ãŖãããįĄåšåãŽæįĩæŋčĒãã᏿˛ĸãããŽįŊ˛åã§ãã
ãæ˛ŧį°ã¯å°ããŽããã éģãŖãĻãããããããããŖããã¨æ¤ åãŽčãĢäŊãé ãããį§ãĢã¯ããŽåäŊãŽæåŗããããŖããéãčˇįŠãčĒåãŽčŠããåĨãŽå ´æã¸į§ģãã¨ããŽåäŊã ã
ã᏿˛ĸããã¯ããããĒããã¨æ˛ŧį°ã¯č¨ãŖãããäēĄããĒãŖãæšãæĒãč¨ããŽã¯åŋãŗãĒãããäēåŽã¨ããĻåŊæãŽč˛Ŧäģģã¯į¸æ˛ĸãããĢããŖããäŧį¤žã¨ããĻããæ´įããããåžãĒããæŦäēēãåčĢã§ããĒãäģĨä¸ãæã ãåæãĢåēããã¨ãã§ãããFDAãĢã¯éåģãŽįĩåļäŊåļãŽåéĄã¨ããĻčĒŦæãããäģãŽäŊåļã¯å¤ããŖããã¨ã
ãį§ã¯æēãŽä¸ã§ä¸ĄæãéããĢįĩãã§ããã
ãäŧį¤žã¯čĒåãã᏿˛ĸãŽä¸ãĢæåãŽįŗãįŠãã ãį§ã¯äŊãč¨ãŖãĻããĒããčĒå°ãããĻããĒããį§ã¯ãã ãäēåš´åãŽčĒŋæģč¨é˛ãæŦįŠã ãã§éãĒãæ´ããĻįŊŽããĻãããã ãã ãããŽč¨é˛ã¯į¸æ˛ĸãŽįŊ˛åã§éããããĻãããįŊ˛åãŽããå ´æãĢč˛Ŧäģģã¯æĩããĻãããæ°´ãčĒįļã¨äŊãå ´æãĢæĩãããããĢã
ãį§ãč¨č¨ãããŽã¯č¨é˛ã ãã ãč¨é˛ã¯äēēãŽåŋãåæãĢããæšåã¸æĩããį§ã¯ããŽæĩããã¤ãããããå°ãã ãåžããčĒŋæ´ããã ãã ãåžããã¤ããč ãŽåã¯ãŠããĢãæ¸ããĻããĒããæ¸ããĻããĒãããŽã¯č˛ŦããããĒãã
ãã˛ã¨ã¤ãįŗãä¸ããžããã¨ãčŦäēãŽč˛Ŧäģģč ãåŖãéãããåŊŧã¯čĨãé ãĢæĩˇå¤ãŽčĻåļ寞åŋãããĻããįˇã§ãããŽå ´ã§ããĄã°ãäēæ ãŽéããæŖįĸēãĢæ¸Ŧããäēēéã ãŖãããWarning Letterã¸ãŽåįããžãä¸ååã¨å¤æãããã°ãæŦĄã¯čŧ¸å ĨčĻåã§ããAP-204ã ãã§ã¯ãĒããããŽåˇĨå ´ã§äŊãįĄčæŗ¨å°å¤ããšãĻãįąŗåŊã¸åēčˇã§ããĒããĒããžãããããĒãã°ãæĩˇå¤ãŽæĒįŊŽãįįąãĢåŊå åŊåąãåŋ ãåããæģå¯ããããĻââææĒãŽå ´åãæĨååæĸã§ãã
ãäŧč°åޤãéãžãčŋãŖãã
ãæĨååæĸãĢãĒãã°ãã¨čŦäēãŽč˛Ŧäģģč ã¯įļãããåŖ°ãå°ãæ ããĻããããããŽåˇĨå ´ãŽåäēįžäēēã¨ãéĸéŖäŧį¤žãããããéåãŽéŖå ãį¤žåŽ ãŽããįēãžã§åĢããĻįæ´ģãĢåŊąéŋãåēãžããæã ã¯čŦãäŊãŖãĻäēēãæ˛ģãäŧį¤žãŽã¯ãã§ããããããäģãčĒåããĄãŽč¨é˛ãŽã˛ã¨ã¤ã§ãčĒåããĄãŽįēãžã§ãæĸãããã¨ããĻããã
ãčǰããäŊãč¨ããĒããŖãã
ãį§ã¯ããŽæ˛éģãŽä¸ã§ä¸Ąæãįĩãã ãžãžåããĒããŖããčŦäēãŽč˛Ŧäģģč ãä¸Ļãšãæ°åã¯ãããšãĻæŦåŊãŽãã¨ã ãŖããåäēįžäēēãéåãŽéŖå ãį¤žåŽ ãŽįēããããã¯äēåš´åãį§ãčŖŊé å´ãŽæ°´ããčĒŋãšãĒããã¨æąēããããŽä¸įšããããžãŖãããĢã¤ãĒããŖãĻãããããŽå¤ãį§ãæĸããããĒããŖããŽãåãããŽã ãŖãããŠã¤ãŗãæĸããã°æļããčǰããŽäģäēãį§ã¯äēåš´åãäŊįžäēēãŽäģäēãåŽããããĢãã˛ã¨ã¤ãŽæŋããįĄåšãĢããããããĻäģãããŽäŊįžäēēãŽäŊåããŽįæ´ģããåãč¨é˛ãŽããã§æĸãžããã¨ããĻãããåŽããããĢé ããããŽããåŽãŖãã¯ããŽããšãĻãåŖããã¨ããĻããã
ãå¤é¨ãŽåãåãããšãã§ããã¨čŦäēãŽč˛Ŧäģģč ãč¨ãŖãããããŧãŋã¤ãŗãã°ãĒããŖãŽæ¯æŖãå°éãĢããŖãĻããįŦŦä¸č ãŽãŗãŗãĩãĢãŋãŗãããį¤žå ãŽäēēéã ãã§åįãæ¸ããĻãFDAã¯ããäŋĄããžãããåŽĸčĻŗæ§ãčĻããžãã
ãč˛ģį¨ã¯ãã¨æ˛ŧį°ãč¨ãŖãã
ãč˛ģį¨äēã ãŽč°čĢãããĻããäŊå°ã¯ãĒãã¨čããžããäŧį¤žãæŽãããŠãããã¨ãã芹ã§ãã
ãæ˛ŧį°ã¯ãéˇãæ¯ãåããããâĻâĻæé ããĻããã
ãįŦŦä¸č ãŽãŗãŗãĩãĢãŋãŗããį§ã¯ããŽč¨čãé ãŽé ãĢæ¸ãįãããåŽĸčĻŗįãĒå¤ãŽįŽããããžã§į§ãŽįŠčĒãčĒãã§ãããŽã¯ãį§ãŽãã¨ããčĒ åŽãĒæĄč°ˇãããã ã¨æãŖãĻããäēēéã°ããã ãŖããä¸åŽ ããæ˛ŧį°ãããŠããŦãšã§ãããį§ã¨ããäēēéãããį¨åēĻã¯äŋĄį¨ããããã§č¨é˛ãčĒãã§ãããã ãå¤ããæĨãäēēéã¯éããčǰãäŋĄį¨ããĒãįŽã§č¨é˛ã ããčĒããããã¯æ°ããį¨ŽéĄãŽč å¨ã ãŖããč å¨ã¯é ãŽé ãĢæ¸ãįããĻããã
ãæĄč°ˇãã¨ä¸åŽ ãį§ãčĻããããåãäēåš´åãžã§éĄãŖãĻįšæ¤ããĻãããĻãããåŊæãŽč¨é˛ãŽæ´åã¯ãåãããĄã°ãææĄããĻãããĒã
ãææĄããĻããžããã¨į§ã¯įããã
ãã§ã¯ã᏿˛ĸãããŽåŊæãŽå¤æãĢã¤ããĻãåŽĸčĻŗįãĢčĒŦæã§ããčŗæããåãŽãģãã§ãžã¨ããĻãããFDAã¸ãŽå῏ãĢæˇģããããŗãŗãĩãĢãĢãããŽčŗæãæ¸Ąãã
ãããããžããã
ãį§ã¯é ˇããã
ãäēĄããĒãŖãäēēãŽå¤æãåŽĸčĻŗįãĢčĒŦæããčŗæããããį§ããžã¨ãããããäģĨä¸į§ãĢã¨ãŖãĻéŊåãŽããåŊšåãã¯ãĒããŖããæģč ãŽåŧčˇäēēããããŽæģč ãæ˛ãããäēēéãäģģããããčǰãããŽåĨåĻããĢæ°ãĨããĒãã
ã᏿˛ĸãããį§ãããĒããčĒããžããããĒãã¯ãããäŊãč¨ããĒãããã
âãâãâ
ããŗãŗãĩãĢãŋãŗããŽæé ã¯é˛ãã§ãããã ãåŊŧããåŧãåãããŽã¯ãåčŗĒæåãŽåˇæ°ããįŖįŖäŊåļãŽåŧˇåãé¸čąåĻįãŽåč¨č¨ãĒãŠââčĻãããĢåčŗĒãŦãããŗãšãŽįĢãĻį´ãã ãŖããäēåš´åãŽAP-204ã§įžå ´ãĢäŊãčĩˇãããŠãŽčããŠãããåēãĻããĒãįĄåšã¨å¤æãããŽããããŽæčĄįãĒä¸čēĢãæ¸ãããŽã¯åŊæãŽč¨é˛ãããĄã°ãæˇąãįĨãäēēéããããĒããã¤ãžããį§ã ãŖãã
ãããããĻWarning Letterã¸ãŽå῏ãį§ãæ¸ããã¨ãĢãĒãŖããå¤é¨ãŽįŽã¯å Ĩããããããį§ãįŠčĒãæ¸ãåå°ã¯æŽãããã
ãWarning Letterã¸ãŽåįã¯æéããããåååäēåļæĨæĨäģĨå ãĢãææ¸ã§åįããĒããã°ãĒããĒãããããæąãããããŽã¯ãCAPAã˛ã¨ã¤ã§ã¯ãĒããŖããéåģãģįžå¨ãģæĒæĨãŽä¸ã¤ããããããĻåˇŽãåēãã¨č¨ãŖãĻããã
ãéåģãĢã¤ããĻã¯ãåŊæãŽããŧãŋãŽäŋĄé ŧæ§ãŽæŦ éĨããŠãŽããããĢãŠããžã§åãã§ãããŽãããã§ãĢåēčˇããå¸å ´ãĢããčŖŊåã¸ãŽåŊąéŋãžã§åĢããĻčŠäžĄãããã¨ãįžå¨ãĢã¤ããĻã¯ããĒããããčĩˇãããĒãčĻéãããããŽãã¨ããæ šæŦåå ãŽåæããããϿǿĨãĢã¤ããĻã¯ãčŠĻé¨ãŽäģįĩãŋã¨ãããįŖįŖãããŦãããŗãšãæ šãããäŊãæŋãããæ¯æŖæĒįŊŽč¨įģââCAPAââã
æ¸ããĒããã°ãæŦĄãæĨããæŦĄã¯čŧ¸å ĨčĻåīŧImport Alertīŧã ãįąŗåŊãéæą ããĄãŧããŽčŖŊåãåŊåĸã§æĸãããAP-204ã ãã§ã¯ãĒããåãåˇĨå ´ã§äŊãããšãĻãŽįĄčæŗ¨å°å¤ããįąŗåŊãŽå¸å ´ããᎠãåēãããããããĻããŽå ąãã¯ãåŋ ãæĩˇãæ¸ĄãŖãĻæģãŖãĻãããæĩˇå¤ã§čŧ¸å ĨčĻåãåããåˇĨå ´ããæĨæŦãŽčĻåļåŊåąãæžãŖãĻããã¯ãããĒããæģå¯ããããĻæĨååæĸåŊäģ¤ãåååŊäģ¤ãä¸éãŽæį´ããå§ãžãéŖéãŽæåžãĢã¯ãäŧį¤žãŽč§ŖäŊãåž ãŖãĻããã
ãä¸ã¤ãŽããĄãį§ãããĄã°ãæãããŽã¯æåãŽã˛ã¨ã¤ã ãŖããå¸č˛ŠåžãŽčŖŊåãĢåŊąéŋã¯ãĒããŖãããã¨ããéĄããŽåããããã¯äēåš´åãį§ãčŖŊé å´ãŽæ°´ããčĒŋãšãĒããã¨æąēããä¸įšãĢãžãŖããã¤ãĒããŖãĻãããããŽåããĢã ãã¯ãæŦåŊãŽįããæ¸ããããĢã¯ãããĒããŖãã
ãåčŗĒäŋč¨ŧã¯æŦæĨãæŖč ãåŽãäģįĩãŋã ãį§ã¯ããŽäģįĩãŋãčĒåãåŽããããĢäŊŋãŖãĻãããäēåš´åã¯æŖč ãį į˛ãĢããĻããããĻããžã¯ãäŧį¤žããŽããŽãããĄã°ãæˇąãã¨ããããééŖããĢããĻãããã§ããäģæããģãŠéããĢåšãã
ãį§ã¯å῏ãŽčæĄãäŊæĨããããĻįĩãã ã
ãæéĸãŽčĄ¨åããŽä¸ģčĒã¯ãã¤ããĢãåŧį¤žã¯ãã ãŖããåŧį¤žã¯åŊæãŽããŧãŋã¤ãŗãã°ãĒããŖãģãŦãããŗãšãĢčåŧąæ§ãããŖããã¨ãčĒčããĻãããåŧį¤žã¯åŊæãčŠĻé¨ãåŽæŊããč ã¨ãããŽįĩæãŽčŠäžĄãģįĄåšåã夿ããč ã¨ãŽåŊšå˛åæãä¸ååã§ããŖããã¨ãčĒãããåŧį¤žã¯åŊæãŽåčŗĒč˛Ŧäģģč ãŽå¤æãããģãšã忤č¨ŧããââ
ãåŊæãŽåčŗĒč˛Ŧäģģč ã᏿˛ĸãŽãã¨ã ã
ãį§ã¯į¸æ˛ĸãŽåãį´æĨæ¸ããĒããŖããæ¸ãåŋ čĻããĒããŖããåŊæãŽåčŗĒč˛Ŧäģģč ãã¨æ¸ãã°ããŽæŋčĒãŽįŊ˛åã¯ã˛ã¨ã¤ãããĒããčĒãč ã¯čĒåã§ååãčŖããį§ã¯įĸãæžããĒããįĸãŽåãæšåãæ´ããã ãã ããã¨ã¯čĒãč ãŽįŽãåæãĢããĄãã¸éŖãã§ããã
ãåŊšå˛åæãä¸ååã ãŖããã¨ãã䏿ã¯ã¨ãããæ éãĢæ¸ãããäēåš´åãįĄččŠĻé¨ãåŽæŊãããŽããããŽéŊæ§ããåŊéŊæ§ãã¨čŠäžĄããĻįĄåšåãä¸ģå°ãããŽãåä¸äēēįŠã ãŖããčˇååæãŽæįŊãĒéåãããã¯æŦåŊãŽãã¨ã ãFDAãããĄã°ãåĢããã¨ã ã
ããã ãããŽãåãä¸äēēãŽäēēéããčǰã ãŖããããå῏ãĢã¯æ¸ããĒããæ¸ãã°į§ãŽåŊæãŽčˇåãĢčĄãåŊããããã ãį§ã¯åŊæãQCãŽã垎įįŠčŠĻé¨ãŽæ åŊč ã ãŖããåŽæŊãããŽããčŠäžĄããĻįĄåšã¨å¤æãããŽãââ
ãã ããį§ã¯ãããŽä¸ģčĒãæļãããåŊšå˛åæãä¸ååã§ããŖããã¨ããįļæ ã ããæ¸ãããčǰãããŽäēåŊšãå ŧããĻãããŽããã¨ããä¸ģčĒãæãããä¸ģčĒãŽãĒãæã¯čǰãåæãã§č˛ŦããĒããã ãé¸čąãĢã¯č˛Ŧããč˛ ãčǰããčĻããåæããŽãĒãæãčĒãã įŽã¯ãč¨é˛ãĢæŽãå¯ä¸ãŽåââæŋčĒãŽįŊ˛åãŽããæšåã¸čĒįļã¨åããŖãĻããã
ãä¸ģčĒãæããã¨ããäŊæĨããį§ã¯ããäŊįžåãããŖãĻãããã ãäģåēĻã°ããã¯ãæããä¸ģčĒãŽå ´æãĢčĒåãŽéĄããŊãŖããã¨įŠēããĻčĻããæ°ããããįŠēįŊãĢã¯æŦåŊã¯į§ãįĢãŖãĻãããįĢãŖãĻãããŽãĢãčǰãĢãčĻããĒããčĻããĒããããĢį§ãããŽįŠēįŊãäŊãŖããŽã ããã
ãį§ã¯ããŽįŠēįŊãäŊåēĻãčĒãŋčŋãããčĒãŋčŋãããŗããããĢįĢãŖãĻããã¯ããŽčĒåãå°ããã¤čããĒãŖãĻããæ°ããããä¸ģčĒãæļãã¨ã¯ãæããčǰããŽåå¨ãæļããã¨ã ãã ã䏿č°ãĒããŽã§ãäģäēēãæļãįļããĻããããĄãĢå ãĢæļããĻãããŽã¯ãæļããĻããį§čĒčēĢã ãŖããäēåš´ãããĻãį§ã¯č¨é˛ãŽä¸ããčĒåãä¸čĒãã¤æããĻããããããįŊ˛åã¯æļããĻããĒããæļãã°čˇĄãæŽããčŠĻé¨ãããæĄč°ˇãŽåã¯äģãæŽãŖãĻãããį§ãæãããŽã¯ãããŽåãĢįŊĒãįĩãŗã¤ããä¸čĒãŽãģãã ãæ°ãĨãã°ãåãč˛ ããšããį§ãã¯ããŠããĢãããĒããŖãããŠããĢãããĒãäēēéã¯ãčǰãĢãæãžããĒããã ããŠããĢãããĒãäēēéã¯ãããļãããįããĻããĒããŽã¨åãã ãŖãã
ãä¸åŽ ã¯į§ãŽčæĄãčĒãã§ããããæ¸ããĻãããã¨č¨ãŖãããåŽĸčĻŗįã§ãčĒ åŽã ãã¨ã
ãčĒ åŽãã¨ããč¨čãį§ã¯ãããããļãéˇãããã ãčĒåã¸ãŽč¤ãč¨čã¨ããĻčããĻãããčĒ åŽãĒč¨é˛ãčĒ åŽãĒčĒŋæģãčĒ åŽãĒéį¤ēãį§ãģãŠčĒ åŽã¨ããč¨čãéå ˇã¨ããĻäŊŋãããĒããĻããäēēéãããĒãã ããã
âãâãâ
ãããŽéąãĢį¤žå ãŽįŠēæ°ãå¤ãããŽã¯ãWarning Letterã ãã§ã¯ãĒããŖãã
ã厤äŧãŽæģããããææģãŽéåŋãåãã¯ãããã
ããããčĻå¯ãææģæšéãããããäŧį¤žãĢåããããã§ã¯ãĒãããã ãä¸åŽ ãŽã¨ããã¸æšããĻäēæ č´åãŽčĻčĢãæĨãĻãããŽåæ°ããåããŽį´°ããããå¤ããŖãĻãããčǰãčŖãŽéį¨åŖãæŠããããããŽå¤ãčǰããŠããĢããããåŽå ¨ãĢäēäģļã¨ããĻãŽįˇãįãåãã ãŖãã
ãããŽéåŋããĒãåžãããŽããį§ãĢã¯čĻåŊãã¤ããĻããããģãã§ããĒããæį°ãåēĻã ãĄãã¤ãããĻããããŽãæãããæãããįŠæĩã˛ãŧãå´ãŽãĢãĄãŠãŽæģč§ããããĻã厤äŧãããŽå¤ãčǰããåž ãŖãĻããã¨æãããåæéãŽįŠēįŊã
ãį¤žå ã¯ããã¤ãããäēæ ã§ã¯ãĒããŽãĒãäŊãĒãŽããčǰãã厤äŧããããŽéæŽĩãããããŽåãã¯čǰããã¨ããĒããåģä¸ããįĩĻæš¯åޤããåĢį æãæĩããĻããŖãã
ããããĻãæĩããŽčĄãįãå ã¯ãããĻãåãå ´æã ãŖãã
ã厤äŧã¯ããŽå¤ãčǰããåž ãŖãĻããã厤äŧã¯æãŽäŊããįĨãŖãĻããĻãããã襨ãĢåēããã¨ããĻããââãããžã§ã¯åããčǰããåãįĩĩãæããĻãããã§ã¯ã厤äŧãĢéģãŖãĻããĻãģãããŖããŽã¯čǰãã
ããģã¨ããŠãŽčˇåĄã¯ãäēåš´åãŽįį¸ãįĨããĒããããããä¸įŠãĒįŠēæ°ã¯čǰããæãåãŖãĻããââFDAãĢããžčŋŊãããĻããå¤ã䏿Ŗãããããããæ´ãããĻããĄã°ãå°ããŽã¯ãäŧį¤žãŽä¸ãŽãģãã ãæģå¯ã§čļŗå ãŽåžããããįĩåļéŖã ã
ãã ããäēēã ãŽįŽã¯čĒįļã¨ä¸ãåãããæ˛ŧį°ãåĢãä¸ãŽãģããã
ãį§ã¯ããŽæĩããæĸããĒããŖããæĸããįįąããĒããŖãã
ãæį°ã¯åŽéãĢæ˛ŧį°ãč´åããããããæ˛ŧį°ã厤äŧãĢ寞ããĻãæģå¯ãŽåãĢäŊč¨ãĒãã¨ãč¨ããĒãã¨ããčļŖæ¨ãŽå§ããããĻãããã¨ããč¨ŧč¨ã褿°åēãã¨ãããããã¯ããļãæŦåŊãŽãã¨ã ãŖããæ˛ŧį°ã¯ããããįˇã ãäŧį¤žãåŽããããĒãäēēãŽåŖãåĄããĢããã
ãåģä¸ã§ãį§ã¯č´åãįĩããĻæģãŖãĻããæ˛ŧį°ã¨ããéãŖããåŊŧãŽéĄã¯į°č˛ã ãŖããį§ãčĻãĻãåŊŧã¯äŊããåãæ¨ãĻããããĢč¨ãŖãã
ãåčĢãããĒããį§ã厤äŧãįĒãčŊã¨ãã¨ã§ãč¨ããŽãã
ããžãããã¨į§ã¯ãã ãããĢįããããåˇĨå ´éˇãããããĒãã¨ããĒããããããĒãã
ãããã¯åã§ã¯ãĒããŖããį§ã¯æŦåŊãĢããæãŖãĻãããæ˛ŧį°ã¯åޤäŧãįĒãčŊã¨ããĻãĒãŠããĒãã厤äŧãčŊãĄãã¨ããæ˛ŧį°ã¯ããļãčĒåŽ ãĢããã
ã厤äŧãčŊãĄãã¨ããããŽæŋĄããéæŽĩãŽããĄã°ãä¸ãčĻä¸ãããĻãããŽã¯ãæ˛ŧį°ã§ã¯ãĒãã
ãį§ã ã
âãâãâ
ãå¤ãį§ã¯čĒåŽ ãŽæēã§ãäēã¤ãŽįŠčĒãįĩãŋįĢãĻãĻããã
ãã˛ã¨ã¤ã¯äŧį¤žãŽãããŽįŠčĒã᏿˛ĸīŧäēåš´åãŽå¤æãčǤãŖãč˛Ŧäģģč ãããã¯ããäŧį¤žãčĒåã§įĩãŋå§ããĻãããį§ã¯čŖåŧˇããã°ããã
ãããã˛ã¨ã¤ã¯ã厤äŧãŽãããŽįŠčĒã ãŖãã
ãčĻå¯ã¯ã厤äŧãŽæģãäģæŽēãŽæšåã¸åžãããã¨ããĻãããčǰããåŊŧãčŊã¨ãããããŽãčǰããã¯ä¸ãŽãģããŽäēēéã ã¨įãæãŖãĻãããã ãããŽįˇã¯åąãããææģãæˇąãžãã°ããã¤ãįŠæĩã˛ãŧããŽæģč§ãéãŖãäēēéãæŦæ ŧįãĢæĸãå§ãããæģč§ãéããäēēéãäēåš´åãįĨãŖãĻããäēēéãč¨é˛ãĢåŽãããĻããäēēéãããŽčŧĒã¯ãå°ããã¤å°ãããĒããå°ãããĒãŖãčŧĒãŽä¸åŋãĢčǰãããããį§ã¯įĨãŖãĻããã
ãã ããį§ã¯åĨãŽįŠčĒã፿ãããã¨ãĢããã
ãäģæŽēã§ã¯ãĒããčĒæģã
ãââ厤äŧã¯äēåš´åãŽãã¨ãããŖã¨ã˛ã¨ãã§æąããč¯åŋãŽåĩč˛ŦãĢčããããĒããĒãŖãĻãããåŊŧãŽæē帯ãĢã¯ãäēåš´åãŽæŋãŖãåšå°ãŽåįãæļããããĢæŽãŖãĻãããäēēã¯åŋãããããŽãæļããã ã厤äŧãĢã¯ãããã§ãããčĒåãĢįŊ°ãį§ãįļããĻãããââ
ãããã¯åã§ã¯ãĒããŖãã厤äŧã¯æŦåŊãĢåįãæļããĻããĒããŖãã厤äŧã¯æŦåŊãĢčĻããã§ãããį§ã¯ããŽæŦåŊãŽäēåŽãæžãéããåĨãŽįĩĩãæãã ãã§ããã
ãį§ã¯ããŽįĩĩãæŦįŠãŽäēåŽã ãã§įĩãã§ããŖãã
ããžãã厤äŧãŽæčŋãŽæ§åãåŊŧãåĄãã§ãããŽã¯ãįžå ´ãŽčǰããįĨãŖãĻãããčŖŊé ãŽįéˇãĢããã¨ãĒãč¨ãã°ããããã§ãåēãĻããããããäŊåš´ã厤äŧãããé ãåĸããĻãããå¤å¤ãŽãã¨ãã˛ã¨ãã§æŽãŖãĻããã¨ãããŖãããæģå¯ãæąēãžãŖãĻããã¯įŽãĢčĻããĻå æ°ããĒããŖããããŠããæŦåŊãŽč¨ŧč¨ã ãį§ã¯ãããéããã ãã§ãããéããĻãčĻæŠããįˇãŽčŧĒéãæŦįŠãŽč¨čã§æãã
ãæŦĄãĢåŽļæãŽč¨ŧč¨ãäŊŗåãããåäēãĢ芹ããã¨ãããæ¯å¤ãŽå¯č¨ãäŊããĢããŖã¨čŦãŖãĻãããį§ã¯ããããįŊǿǿãŽč¨ŧæ ã¨ããĻããŖã¨įĩĩãŽä¸å¤ŽãĢįŊŽãã
ããããĻåįãæļããããĢæŽãŖãäēåš´åãŽæŋããåŋããããĒãįˇãčĒåãįŊ°ãįļããĻããč¨ŧæ ã¨ããĻã
ãããšãĻãæŦįŠãŽäēåŽã ãŖããį§ã¯ä¸ã¤ã¨ããĻäŊã芹ãčļŗããĒããŖãããã ãããããčĒæģã¨ããįĩčĢãĢåããŖãĻä¸Ļãšį´ãããæŦįŠãŽæ˛ããŋããæŦįŠãŽčĻæŠããæŦįŠãŽč¨ŧč¨ãéããĻããããããããããĒã䏿ŦãŽįŠčĒãįĢãĄä¸ãããåãã˛ã¨ã¤ãã¤ãããĢãäēēã˛ã¨ããŽæģãŽæåŗã丸ãã¨æ¸ãæããã
ããããį§ãŽäģäēã ãŖããæģå¯å¯žåŋããäēåš´åãŽįĄåšåããããžåޤäŧãĢįãããã¨ããĻããčĒæģããæ šã¯åãã ãæŦįŠãŽč¨é˛ãįĩčĢãĢåããŖãĻä¸Ļãšį´ããã¨ãããã ããį§ã¯åæ°åš´ããŖãĻããã
ãčĒæģãĢã¯į¯äēēãããĒããį¯äēēãããĒããã°ãčǰãįãããĒãã
ãį§ã¯åޤäŧãŽãããŽįŠčĒããããįĩãŋįĢãĻããåŊŧãäēåēĻãäŊŋããã¨ãĢãĒããä¸åēĻįŽã¯äēåš´åãį§ãŽãæäŊããšã ãã¨ããč¨čãäŋĄããĻãããããŽåč¯ãããäēåēĻįŽã¯ããžãããŽåč¯ããããŽčĻæŠãã
ã厤äŧã¯ããäēēã ãŖããããäēēãģãŠįŠčĒãŽææãĢããããã
ããããčããĻããæãį§ã¯ãģããŽä¸įŦã ãæãæĸãããã ããæĸãžãŖãæã¯ãããĢãžãåãã ãããä¸åēĻæĸãžãŖãĻãåŋ ããžãåããĻããžããã¨ãį§ã¨ããæŠæĸ°ãŽäģæ§ã ãŖãã
âãâãâ
ãæį°ãį§ãč¨ĒããĻãããŽã¯ããŽæ°æĨåžã ãŖãã
ãäģåēĻã¯åŗéĸã¯åēããĒããŖããåŊŧã¯åŋæĨåŽ¤ãŽæ¤ åãĢæˇąãåē§ãããã°ããį§ãŽéĄãčĻãĻãããä¸é芹ãŽãããĢåŊŧã¯å§ããã
ãæģå¯ãŽãģãã¯čŊãĄįããžãããã
ãããããžã åŊåã¯ãã¨į§ãįããã¨ãæį°ã¯å°ããé ˇããã
ã厤äŧãããæčŋå æ°ãĒããŖãã§ããã
ãæĨããã¨į§ã¯æãŖããį§ãæĩãããæšåã¸ãæį°ãŽãģãããå ĨãŖãĻããã
ãæŖį´ãĢč¨ãã°ãã¨į§ã¯æ éãĢč¨čãé¸ãã ããããäŊåš´ãåĄãã§ãããããĢčĻãããã¨ããããžããããã âĻâĻäēēã¯éˇãäŊããæąããã¨ãããããéĄãĢãĒããŽãããããžããã
ãåã¯ã¤ããĒããŖãã厤äŧã¯æŦåŊãĢåĄãã§ãããį§ã¯ããŽįįąãįĨãŖãĻãããã ãããã¯åŖãĢããĒããŖããį§ããããįĨãŖãĻããããŠããããæį°ã¯č¨ããĒããŖãã
ãæąããããããæį°ã¯æå¸ŗãĢäŊãæ¸ãããĢč¨ãŖãããčĒæŽēãŽįˇãčããĻã¯ãããã§ãããããĄãããããŽå ´æãããŽæéãįēäŊįãĢãã¨ãããã¨ãããã
ãį§ã¯éģãŖãĻé ˇãããåĻåŽãč¯åŽãããĒããŖããåĻåŽããĒããã¨ãããĄã°ããããããčĻããã
ããã ããã¨æį°ã¯įļããããã˛ã¨ã¤ãåããĒããã§ããã
ãåããĒããããŽč¨čãį§ã¯æčŋãåĨãŽå ´æã§ãčããæ°ãããã᏿˛ĸãŽããŧããŽä¸ã ã
ãæããã§ãããã¨æį°ã¯č¨ãŖãããæãããĻãããčĒåã§éŖãŗéããäēēéãããĒãã§æãããæããã§ããæį´ãæ°ãĢããåŋ čĻããĒããæģãŦãã ãããæãããŽã¯æģãã æŦäēēãããĒããčǰãåĨãŽäēēéããã¨ããæãããčĒåãŽįãæļããããĢãããã¯čĒæŽēã¨ã¯į¸æ§ãæĒããã§ããã
ãį§ã¯čĄ¨æ ãå¤ãããĢæį°ãŽčŠąãčããĻããã
ãæį°ã¯æŖãããŖããæãããæãããŽã¯åޤäŧã§ã¯ãĒããį§ã ãčĒåããããĢããįãæļããããĢæãããããŽä¸æãããį§ãŽįĩãã čĒæģãŽįŠčĒãŽæãåŧąãįļãįŽãĢãĒãŖãĻãããį§ãŽįŠčĒãŽä¸ã§ãã ä¸ãæãäēåŽã¨æŖéĸãããļã¤ããå ´æããããããŽæããã ãŖãã
ãį§ã¯ãæ¸ æãŽč¨é˛ãĒãããã¨č¨ããããĻããããããã¯ããæĸãĢåēããĻãããå¤éæ¸ æãããŽåįˇãĢå ĨããĒããã¨ãæį°ã¯ã¨ããĢįĨãŖãĻããã
ãæããããŽã¯ãã¨æį°ã¯įļãããã厤äŧãããčŊãĄããã¨ã§ããčŊãĄãĻããæããããžã§ãŽããã ãããŽæãããŽãã°ãĢčǰããįĢãŖãĻããã
ãčŊãĄãããã¨ãĢã
ãį§ã¯ããŽč¨čãŽä¸ããčĒåãŽčļŗã§ããä¸åēĻæŠããã厤äŧãčļŗãæģãããĻčŊãĄããį§ã¯ããĄã°ãä¸ãčĻä¸ããããããããæãããæããã厤äŧãčŊãĄããã¨ãĢãæį°ãŽč¨čã¯ãį§ãŽããŽå¤ãŽčļŗåããã䏿ŠãééãããĢãĒããŖãĻããããĒããŖãĻããĒãããããŽčļŗåããŽä¸ģããããžįŽãŽåã§ãčļãåēããĻããį§ã ã¨ã¯ãžã æ°ãĨããĻããĒããŖããæ°ãĨããŽã¨ãč¨ŧæãããŽã¯éããåŊŧã¯ããļããããååã¯æ°ãĨããĻãããã ãæ°ãĨãã¯č¨é˛ã§ã¯ãĒãã
ãæĄč°ˇãããã¨æį°ã¯ãĩããĢåŖ°ãŽčĒŋåãå¤ããããã˛ã¨ã¤ã ãå¤ãĒãã¨ãč¨ããĻããã§ããã莿Ĩį ã§ãã
ããŠããã
ãããĒããŋãããĢãč¨é˛ãäŊãäģäēãããĻãäēēã¯ããããļãäēēããįãæļããŽã䏿ãã¨æããã§ããããŠããĢäŊãæŽããããįĨãŖãĻããããéãĢãããŠããæãã°æļããããįĨãŖãĻããåŊŧã¯į§ãŽįŽãčĻãããããŽæãããæããäēēéã¯ãããļããããããã¨ãįĨãŖãĻãäēēéã ãį´ äēēã¯æãããĒããĻæ°ãĢãįããĒãã
ãį§ã¯ããčļãä¸åŖéŖ˛ãã ã
ãåäēããããããã§ããããã¨į§ã¯č¨ãŖããããŠããĢäŊãæŽããããåãã ã
ããããæį°ã¯įŦãŖãããã ãããããããĻãã¤ããéãŖãĻãããã§ã
ãåŊŧã¯æš¯åãŋãįŊŽãããĩã¨įéĄãĢãĒãŖããããããžã§čŠąãã¨ãããããĻããŽäēēã¯č¨ããã§ãããį§ãįãŖãĻããã§ãããã¨ãåŋå¤ã ã¨æ°č˛ã°ãäēēããããããĒãã¯ä¸åēĻãč¨ããĒãã
ãč¨ãã°æĨŊã ãŖããįãŖãĻãããŽãã¨ãč¨ããĻåĻåŽãããã°ãäēēã¯ã˛ã¨ã¨ãåŽåŋãããã ãããŽä¸č¨ã¯į§ãŽåãã¯ãŖããįĩãŗã¤ãããį§ã¯įĸãæžããĒãã
ãįããŽãæ´ãããŽããåäēãããŽãäģäēã§ããããã¨į§ã¯č¨ãŖãããį§ã¯č¨ããããã¨ãĢįããã ãã§ãã
ãåŊŧã¯įĢãĄä¸ããŖãã
ãåĻãĒäēäģļã§ããã¨æį°ã¯č¨ãŖãããčĒæŽēãĢããĻã¯ãčǰãããããäģæŽēãĢããĻã¯ãčǰãæŧããĻããĒãããããæŧããã¨ããč¨ŧæ ããĒããčŊãĄããŽã¯æŦäēēã ãããĒãŽãĢãããĢčǰããããããããĢããããããéģãŖãĻįĢãĄåģãŖãã
ãããĻãéģãŖãĻãįĢãĄåģãŖãã
ãããã¯æŽēäēēã ããããį§ãĢã¯ããããĒããŖããæŗåžããããäŊã¨åŧãļãŽããæãä¸ãããĢãã čĻãĻããč ããåˇŽãåēããããæãåŧãŖčžŧããč ããæį°ã¯ããļãããŽįããæĸããĻããããããĻããŽįããĢããĄã°ãčŋãå ´æãĢįĢãŖãĻããäēēéããåŊŧãĢé ãä¸ããĻčĻéããŽį¤ŧãããĻããã
âãâãâ
ããžã æ´ããĻããĒãč¨é˛ããã˛ã¨ã¤æŽãŖãĻããã
ã᏿˛ĸãŽéãããŧãã
ãããŽãåããĒãįšããŽé ãããã¯į§ãŽããĄã°ãčŋããĢããåąéēã ãŖããäēåš´åã᏿˛ĸãį§ãŽčĒŦæãĢįããæãŖãããŽč¨ŧæ ã ããæĄč°ˇãããŽčĒŦæãĢã¯ãã˛ã¨ã¤ãåããĒãįšããããââåæãã ãį§ãŽåããããĢæ¸ããĻããã
ãäēåš´éãį§ã¯ä¸åēĻãæļããĒããŖããæŽãæšã ãã§ããšãĻãæãŖãĻãããã ãããŽä¸é ãŽåã§ã ãã¯ãæããĻįãããĻããžãããã¨ããčĄåãĢãããããããŽããŧããĢã¯ãį§ãŽåãč¨é˛ãããĻããã
ãããã§ããį§ã¯ããŽæãäŊŋããĒããããŽããŧãã¯ããį§ã ããŽããŽã§ã¯ãĒããæĸãĢäŊåãčĻãĻãããįˇåã¯į¸æ˛ĸãŽéēåã¨ããĻææĄããĻãããããžããä¸é ã ããæļããĻããã°ãæļããĻãããã¨čĒäŊãåĢãŗåŖ°ãĢãĒããæļããã¨ã¯ããĄã°ãįŽįĢã¤ãįŖæģč¨ŧ补ãéˇåš´æąãŖãĻããį§ãčǰããããįĨãŖãĻãããã¨ã ãŖãã
ãį§ã¯ââčĒãŋæŋããã
ã᏿˛ĸãä¸ģį¯ãĒããäēåš´åãŽå¤æãčǤãŖãåŧĩæŦäēēãĒããããŽãåããĒãįšããããã¨ããé ãĢãŠãŽãããĒæåŗãæããããã
ãããã¯ã᏿˛ĸčĒčēĢãŽč¯åŋãŽåģãã ã
ãčĒåãããããæŋčĒãããã¨ããĻãã夿ãĢãčĒåã§åŧãŖãããŖãĻãããåããĒãįšãããã¨æ°ãĨããĒãããããã§ãįŋæĨãããĢįŊ˛åãããæ°ãĨããĻããĻãĒãæŋčĒããäēēéãããŽåå¤ãã˛ã¨ãããŧããĢæ¸ãã¤ããčŋˇããããčĒãã°ããŽé ã¯į§ãæãįĸã§ã¯ãĒããĒãã᏿˛ĸãŽįŊĒãŽčĒįŊãĢãĒãã
ãåãä¸é ãåãä¸čĄãŽæåãčĒãŋæšãå¤ããã ãã§įĸãŽåããå¤ããã
ãį§ã¯į¸æ˛ĸãŽããŧããæļããĒãã¨æąēããããããŠãããį§ã¯ããããFDAã¸ãŽå῏ãŽåččŗæãĢåĢãããã¨ãĢãããåŊæãŽQAč˛Ŧäģģč ãčĒããŽå¤æãĢã¤ããĻå įįãĒč¨é˛ãæŽããĻããã¨ããĻãčĒ åŽãĒäŧį¤žã¯éŊåãŽæĒãč¨é˛ãé ããĒããé ããĒããã¨ãããĄã°ãčĒ åŽãĢčĻããã
ãį§ã¯é ããĒããã¨ã§ããĄã°ãæˇąãé ãã
ããĩã¨ã᏿˛ĸãĢåããĻäŧãŖãæĨãŽãã¨ãæãåēããã
ãį§ããžã QCãŽčŠĻé¨åޤã§įŊčĄŖãŽčĸãčŠĻčŦã§æąããĻããé ã ãåŊæãŽåčŗĒįŽĄįčǞéˇã ãŖã᏿˛ĸããåšå°ãŽåãĢįĢã¤į§ãŽæå ãåžããããŽããčžŧãã§č¨ãŖãã
ãæĄč°ˇãããããŋã¯æãããã
ãčĒãããããŽã ã¨į§ã¯æãŖããã ã᏿˛ĸãįļããč¨čã¯éãŖãã
ãæãããäēēéãģãŠč¨é˛ãčģŊãčĻããĄã ãčĒåãŽč ãäŋĄããĻããããããã ããããããããŋãŽæããŠãã ãæŖãããĻãããããæŖããã¨č¨ŧæãããŽã¯ããŋãŽæãããĒããč¨é˛ã ãč¨é˛ã ãããã¨ããããŋãåŽãŖãĻãããã
ãč¨é˛ã ãããããŋãåŽãŖãĻãããã
ãããŽč¨čããį§ã¯ããļã᏿˛ĸãæŗåãããĒããŖãæšåãĢč˛ãĻãã᏿˛ĸã¯ãč¨é˛ãããäēēãåŽãįžãĢãĒãã¨æãããį§ã¯ããããäēēãæ˛ããéīŧãããīŧãĢå¤ãããåãč¨čããį§ããĄã¯æŖå寞ãŽããŽãäŊãŖãã
ãããã˛ã¨ã¤æãåēããã¨ãããã᏿˛ĸãäēĄããĒãååš´ãģãŠåãŽãã¨ã ããã§ãĢįŠããĻįžå ´ãéã芹ãåēãĻããé ãåŊŧã¯åģä¸ã§į§ãåŧãŗæĸããĻããč¨ãŖãã
ãæĄč°ˇãããããŋãĢã˛ã¨ã¤ã ãč¨ãŖãĻãããããã¨ãããŖãĻãã
ãį§ã¯čēĢæ§ãããAP-204ãŽãã¨ãæåžãĢåãåēãã¤ãããã¨æãŖããã ã᏿˛ĸãč¨ãŖããŽã¯ãžãã§éããã¨ã ãŖãã
ãããŋã¯ããļããį§ãčĻãĻããä¸ã§ããĄã°ãč¨é˛ãŽããžãäēēéã ãã ããåŋé ãĒãã ããããžãč¨é˛ãããžãã¨ããäēēã¯č¨é˛ãŽãģããæŦåŊã§ãčĩˇãããã¨ãŽãģããåã ã¨æããããĢãĒããéãĒãã ããããããžããĒãã ããčĩˇãããã¨ãæŦåŊã ãč¨é˛ã¯ããŽåŊąãĢãããĒããããã ãã¯åŋããĒãã§ããã
ãį§ã¯ããã¯ããã¨įããã
ã᏿˛ĸã¯ããäģĨä¸ã¯äŊãč¨ããĒããŖããåŊŧãæŦåŊãĢAP-204ãŽãã¨ãįĨãŖãĻãããŽããããŽæåžãŽč¨čãį§ã¸ãŽčĻåã ãŖããŽãããã ãŽčããåčŗĒåąãŽįš°ãč¨ã ãŖããŽããäģãããããĒããããããĒããã¨ã¯æ¸ããĒãããã ãåŊŧãŽč¨ãŖããčĩˇãããã¨ãæŦåŊã ãã¨ããä¸č¨ã ãã¯ããĒããäēåš´ããŖãäģãį§ãŽä¸ã§æļãããĢãããį§ãããĄã°ãæļããããŖãä¸č¨ã ãã ããæļããĒããŽãããããĒãã
ã᏿˛ĸã¯æåžãžã§č¨é˛ãäŋĄããĻãããã ããããåŊŧã¯äēåš´åãį§ãŽæ´ããč¨é˛ãäŋĄããĻããžãŖããåŊŧãæŦēãããŽã¯ãģãã§ããĒããåŊŧčĒčēĢãŽį§ãĢ寞ããæãã ãŖãã
ããããĻããžãį§ã¯åŊŧãéēããæåžãŽč¨é˛ââããŽéãããŧãââããåŊŧčĒčēĢãæ˛ããéãĢå¤ãããã¨ããĻãããč¨é˛ã ããããŋãåŽãŖãĻããããã¨æããĻãããäēēããããŽäēēčĒčēĢãŽč¨é˛ã§čŦããã¨ããĻããã
ãæĒããã¨ãããĻãããã¨ããæčĻã¯ãããããļãåãĢããæ¸ãããĒããĒãŖãĻãããã ãããŽå¤ã ãã¯ãããæ¸ãŖãã¯ããŽå ´æãåĨåĻãĢįãã ãįãŋã¯ãããĢåŧãããįãŋã¯ãã¤ããããĢåŧãããããããļãį§ã¨ããäēēéãŽãããĄã°ããããã¨ããã ãŖããįãžãĒããã¨ã§ã¯ãĒããįãã§ãäŊã˛ã¨ã¤æãæĸããĒããã¨ã ã
ãįŋæĨãį§ã¯äŊåãåŧãã ã
ã᏿˛ĸãããŽããŧãããåŽļæãĢãčŋãããåãĢå 厚ãč¨é˛åããĻãããããæģå¯éĸéŖã§åį §ããå¯čŊæ§ããããå ¨é ãšããŖãŗããĻãįŽé˛ãäŊãŖãĻãģãããé ŧãããã
ãį§ããã§ãããã¨äŊåã¯å°ãéãįŊŽããĻč¨ããã
ããããč¨é˛ãŽæąãã¯åãããĄã°ãäŋĄé ŧã§ããã
ãäŊåã¯ãã°ããį§ãčĻãĻãããäŊããįĸēããããããĒįŽã ãŖããããããã
ãããããžãããã¨ãéããĢé ˇããã
ãį§ã¯åąéēãĒããŧããčĒåãŽįŽĄįãŽčŧĒãŽä¸ãĢå ĨããããšããŖãŗãįŽé˛ããį§ãŽæį¤ēã§į§ãŽå῏ãŽãããĢäŊãããã᏿˛ĸãŽæēæã¨ããĻæ´ããããã
ãäŊåãĢäģģãããŽã¯ãåŊŧåĨŗãæãå 叺éĸã§æŖį´ã ããã ãŖããæŖį´ãĒäēēéãäŊãŖãč¨é˛ã¯įãããĒããį§ã¯åŊŧåĨŗãŽæŖį´ãããį§ãŽįŠčĒãŽããĄã°ãå¤å´ãŽä¸å¤ĢãĒå čŖ į´ãĢãããã¨ããĻããã
ãæŖį´ãã¯ä¸ĄåãŽåã ããã¤ãį§ã¯äŊåãĢã¤ããĻããæãŖããã¨ããããããŽåããããĻãŠãĄããåããŽããããŽæãŽį§ã¯ãžã įĨããĒããŖãã
âãâãâ
ãäŊåã¯ããåããã
ãããŧããŽįŽé˛ã¯ãå 叺éĸãĢã§ããããŖãĻããŖããé ãã¨ãŽæĨäģãå 厚ãŽčĻį´ãåŊŧåĨŗã¯į¸æ˛ĸãŽåãä¸åãčĒãŋéŖã°ããĒããŖããåŽļåēčåãŽããããŽč¨é˛ãžã§ä¸å¯§ãĢæžãŖãã
ãį§ã¯ããŽäģäēãļããæēčļŗããĻčĻãĻããããããģãŠæŖįĸēãĒįŽé˛ãããã°ã᏿˛ĸãŽãå įãŽč¨é˛ãã¯ããæŦįŠãããčĻããã
ããã ãåŊŧåĨŗãããĄã°ãéˇãæãæĸããĻãããŽã¯ãAP-204ãŽé ã§ããįĄåšåãŽč¨é˛ã§ããĒããŖããåŽļåēčåãŽããããŽé ã ãŖããåŊŧåĨŗã¯ããŽéåąãĒæ Ŋåšč¨é˛ãŽæĨäģããäŊåēĻãæã§ããŠãŖãĻããã
ãæĄč°ˇãããã¨ããã¨ãäŊåãč¨ãããã᏿˛ĸãããŖãĻäēĄããĒãåãŽäēåš´ãããããŠããĒãæ§åã§ããããį¤žå¤ãĢåēããããããããŠããã¸äŊããéããããã¨ããŖããã¨ã¯ã
ãåĨåĻãĒåãã ãŖããįŽé˛ãŽäŊæãĢãããĒãã¨ã¯čĻããĒãã
ããããééĸã¯åĸããĻããããã ããã¨į§ã¯įãããããĒãããããĒãã¨ãã
ããããããŽé ã ãįå§ããģãã¨éãæ°ãããĻãã¨åŊŧåĨŗã¯ãžãæĨäģãĢįŽãæģããããč¨é˛äŋãŽįãŋãããĒããŽã§ãã
ãå 叺éĸãĒåãŽãã¤ããŽį´°ããã ãããããŽé ãŽįå§ããŠãã§ããããã¨ã ãŖããį§ã¯ããæãŖãã
ãįŽé˛ã ãã§ã¯ãĒããŖãã
ãäŊåã¯į¸æ˛ĸãŽããŧããĢåēãĻããAP-204ãŽįĄččŠĻé¨ãŽäģļãčŖãĨããããã ã¨č¨ãŖãĻãäēåš´åãŽéĸéŖč¨é˛ãžã§éãã¯ãããĻãããåŊæãŽį°åĸãĸããŋãĒãŗã°ãŽč¨é˛ã፿°´ãŽãĸããŋãĒãŗã°ãŽč¨é˛ãåéĸčãŽååŽããŧãŋãã¤ãŗããĨããŧãŋãŽæ¸ŠåēĻč¨é˛ãæģå¯ãŽå¤ãčŖŊé ፿°´ãŽč¨é˛ãæįŗģåãĢä¸ĻãšãĻããããŽã¨ããŽæã¤ããŽãžãžââį§ãäēåš´åãĢãã˛ã¨ã¤ãã¤é¸ãã§é įŊŽããããŽč¨é˛ããĄããåŊŧåĨŗã¯ããžã˛ã¨ã¤ãã¤čĒåãŽæã§ä¸Ļãšį´ããĻããã
ã᏿˛ĸé¨éˇãŽããŧããŽč¨čŋ°ã¨åŊæãŽč¨é˛ãįĒãåãããĻããã°ãã¨åŊŧåĨŗã¯č¨ãŖãããå῏ãŽčŖãĨããĢãĒããžãããã
ããĒããã¨į§ã¯įãããåŊŧåĨŗãŽããŖãĻãããã¨ã¯į§ãŽįŠčĒãčŖåŧˇããäŊæĨãĢčĻãããã ããį§ã¯æĸããĒããŖãããããæåŋãããæ°äēēããããžã§čĒåã§ã
ããã ãåŊŧåĨŗãŽä¸Ļãšæšã¯į§ãŽä¸Ļãšæšã¨ã¯é įĒãéãŖãã
ãį§ã¯ãã¤ããįĄåšäēįąãããč¨é˛ãä¸ĻãšããįĩčĢãå ãĢããŖãĻãããæ¯ããč¨é˛ãåžããĢįŊŽããã
ãäŊåã¯éã ãŖããåŊŧåĨŗã¯ãč¨é˛ãåēæĨäēãŽčĩˇããé ãĢæéãŠãããĢä¸ĻãšãĻãããéŊæ§ãåēãæĨãååŽãčŋãŖãĻããæĨãįĄåšåãæąēãžãŖãæĨãåčŠĻé¨ãŽæĨãåēčˇãŽæĨããããĻãããŽæéčģ¸ãŽããĄã°ãį̝ãĢãå¸č˛ŠåžãŽæčĄįãŽæåãŽįäžãŽæĨãįŊŽããĻããã
ãä¸åēĻį§ã¯åŊŧåĨŗãĢč¨ãããã¨ããããäŊæ°ãĒãå čŧŠã¨ããĻãŽä¸é芹ãŽã¤ããã ãŖãã
ãåã¯ãŠãããĻãã¤ãæéãŽé ãĢä¸Ļãšããã ãįĩčĢããä¸ĻãšããģããčĒãäēēãĢã¯åããããããã
ãäŊåã¯æãæĸããĻãå°ãčããĻããįããã
ãįĩčĢããä¸Ļãšãã¨ãããŽįĩčĢãæŖããčĻããĻããžãããã§ããã¨åŊŧåĨŗã¯č¨ãŖãããįĩčĢãå ãĢįŊŽãã¨ãåžããŽč¨é˛ã¯ãããļããŽįĩčĢãčĒŦæãããããĢãããĢãããããĢčĻãããã§ãæéãŽé ãĢä¸Ļãšãã¨ãč¨é˛ã¯ãã čĩˇããé ãĢãããĢããã ããĢãĒããžãããŠãŽč¨é˛ãįĩčĢãŽåŗæšãããĒããâĻâĻããããã¨ãããžãĢįĩčĢãŽããã ããĢįŊŽãããč¨é˛ãã˛ã¨ã¤ã ãæĩŽããĻčĻãããã§ãããĒãã§ãããĢãããããŖãĻããã
ãį§ã¯ãåŊŧåĨŗãŽæ¨ĒéĄãčĻãĻããã
ãčǰãĢæããŖããã ããã¯ãã¨į§ã¯č¨ããã
ãæããŖãĻãĒãã§ããåŊŧåĨŗã¯å°ããįŦãŖããããã ãäēēãŽäŊãŖãįŠčĒãããŖããã°ãããĻčĩˇããé ãĢæģããŽãæããåĨŊãã§ãããããã¨ãããŽäēēãäŊãé ããããŖããŽããããžãĢčĻãããã§ãã
ãį§ã¯äŊãč¨ããĒããŖãã
ãįĩčĢããä¸Ļãšãã¨įŠčĒãĢãĒããæéãŠãããĢä¸Ļãšãã¨čĩˇãããã¨ãĢãĒãã
ãį§ãäēåš´åãĢäŊãŖããŽã¯ãįŠčĒã ãŖããåŊŧåĨŗãããžäŊãŖãĻãããŽã¯ãčĩˇãããã¨ã ãŖãã
ãããŽéããŽããããĢãį§ã¯ããŽã¨ãæ°ãĨãããæ°ãĨããĻæ°ãĨããĒããĩãããããįŠčĒãč§ŖäŊããæšæŗã¯ã˛ã¨ã¤ãããĒããįĩčĢããįĩãžããããŽããæéãŽé ãĢä¸Ļãšį´ããã¨ã ãããããã°įĩčĢãŽãããĢįŊŽãããč¨é˛ã ãããåē§ããŽæĒãįŗãŽãããĢæĩŽãä¸ããŖãĻãããåŊŧåĨŗã¯į§ãŽįŠčĒãčŖãĨããĻãããŽã§ã¯ãĒããŖããį§ãŽįŠčĒãããŖã¨ã°ãããĻãããį§ãŽįŽãŽåã§ãį§ãŽč¨ąå¯ãåžãĻãį§ãŽæį¤ēã§ã
ãä¸åēĻã ãåĨåĻãĒãã¨ãããŖãã
ãįŽé˛ãŽä¸ãŽãããŽãåããĒãįšããŽé ãŽčĻį´æŦãäŊåã¯ãããĢããæ¸ããĻããã
ãAP-204įĄččŠĻé¨ãĢã¤ããĻã᏿˛ĸé¨éˇãæĄč°ˇæ°ãŽčĒŦæã¸ãŽįåãč¨čŧãįŋæĨãæŦäēēãĢįĸēčĒäēåŽãäģĨåžãæŦäģļãŽč¨čŧãĒããã
ãæŖįĸēã ãŖããä¸åãŽčǤãããĒããŖãã
ãã ãį§ã¯ããäģĨåžãæŦäģļãŽč¨čŧãĒããã¨ããä¸č¨ãĢããĒããįŽãæĸããã
ãããã¯ãããŽæĨãå°ä¸ãŽäŋįŽĄåēĢã§ããŧããæåžãžã§čĒãã ã¨ããį§čĒčēĢãæ°ãĨãããã¨ã¨åãã ãŖãã᏿˛ĸã¯ããŽåžãAP-204ãĢã¤ããĻäēåēĻã¨æ¸ããĒããŖããããŽæ˛éģãŽæåŗãį§ã¯äēéããĢčĒãã ãį´åžããããæ¸ããĒãã¨æąēãããã
ãäŊåã¯ããŽæ˛éģãĢãããããčĻį´ãŽä¸ã§č§ĻããĻãããæ¸ãããĻããĒããã¨ãæ¸ããĻããã
ãč¨é˛äŋã¯éå¸¸ãæ¸ãããĻããĒããã¨ã¯æ¸ããĒããæ¸ããĻãããã¨ã ããč¨é˛ããããĒãŽãĢåŊŧåĨŗã¯ããäģĨåžãæŦäģļãŽč¨čŧãĒããã¨ããä¸å¨ãč¨é˛ããã
ãä¸å¨ãĢæ°ãĨãäēēéãæ˛éģãč¨é˛ããäēēéã
ãį§ã¨åãįŽãæã¤äēēéã ã
ãį§ã¯ããŽä¸įŦãčä¸ãŽããŖã¨åĨĨãŽãģãã§äŊããåˇãããĒããŽãæãããã ãį§ã¯ããŽæčĻããããĢããžãŖããčãããã ãã¨æããã¨ãĢãããåŊŧåĨŗã¯ãã å 叺éĸãĒã ãã ãåĒį§ãĒæ°äēēãããäģĨä¸ãŽæåŗã¯ãĒãã
ãčĻããĻããĻã¯ãããĒããã¨ã¯ããããĢåŋãããį§ã¯ãã¤ãããããĻããã
ãããŽæĨį§ã¯ã˛ã¨ã¤åŋãããã¨ãĢæąēãããäŊåãŽįŽé˛ãŽãããŧããĢã¯æ¸ããĻãĒããŖãããŽä¸č¨ãã
ããããĒãŽãĢãåŋããã¨æąēãããã¨čĒäŊãããžããžã čĻããĻãããåŋããããĒããŖããŽã ã
âãâãâ
ãããŽéąãŽéæãŽå¤ã ãŖãã
ãæŽæĨãŽäēēåŊąããžã°ããĢãĒãŖãé ãäŊåãį§ãŽå¸ãžã§æĨããæãĢčãį´ãŽããĄã¤ãĢãæãŖãĻãããéģåã§ã¯ãĒããį´ã ãŖãã
ãæĄč°ˇãããã¨åŊŧåĨŗã¯äŊãåŖ°ã§č¨ãŖãããå°ãããæéããã§ãããããã§ã¯ãĒããĻã
ãį§ã¯åŊŧåĨŗãŽéĄãčĻãããã¤ããŽå 叺éĸãĒč¨é˛äŋãŽéĄã§ã¯ãĒããŖããããŖã¨åĨĨãŽãäŊããæąēæãããããĒäēēãŽéĄã ãŖãã
ãį§ããĄã¯čǰãããĒãå°äŧč°åޤãĢå ĨãŖããåŊŧåĨŗã¯ããĸãåžãæãĢéãããéããéŗãããããĢéãã ãŖãã
ããããã¨åŊŧåĨŗã¯į´ãŽããĄã¤ãĢãæēãĢįŊŽããããäēåš´åãŽãAP-204ãŽããããŽæŖč ãĒãšãã§ããå¸č˛ŠåžãŽåŽå ¨æ§å ąåããã¨ãĢį§ããžã¨ããžããã
ãåãŽįšæ¤į¯å˛ãããĒããã¨č¨ãŖãã¯ãã ã
ãã¯ããã¨åŊŧåĨŗã¯č¨ãŖãããã§ããčĻãĻãģãããĻã
ãį§ã¯ããĄã¤ãĢãéããã
ãįäžãŽä¸čϧã ãŖããæŗ¨å°į¨čŖŊå¤AP-204ãå¸č˛Šåžãåä¸ãããå¨čžēã§å ąåããããæčĄįãŽįäžãæĨäģãåš´éŊĸãæ§åĨãčģĸ帰ãããã¤ããŽčĄãŽčģĸå¸°ãŽæŦãĢãåãäēæåãä¸Ļãã§ããã
ãæģäēĄãæģäēĄãæģäēĄã
ãį§ã¯ããŽä¸čϧãä¸ããä¸ã¸čĒãã ãčĒããĩãããããŽã§ã¯ãĒããæŦåŊãĢčĒãã ãäēåš´åãį§ãįĄåšãĢããã¯ããŽããŽæŋãããäēēãŽåŊĸãããĻãããĢä¸Ļãã§ãããåš´éŊĸãæ§åĨãčģĸ帰ãį§ãį´ãŽä¸ã§ããĒããŖããã¨ããĢããããŽããåĨãŽį´ãŽä¸ã§ãããŖããã¨ãã¨ããĻįĸēåŽããĻãããč¨é˛ã¯įĄåšãĢã§ãããã ãč¨é˛ãæããĻããįžåŽã¯įĄåšãĢãĒããĒããį§ã¯ããŖã¨ãããŽäēã¤ãåãããŽã ã¨æãčžŧããã¨ããĻãããéãŖããį§ãįĄåšãĢã§ãããŽã¯į´ãŽä¸ãŽæ°åãč¨åˇã ãã ãŖããããããæããĻããäēēããĄã¯ãå¸č˛ŠåžãŽä¸įã§ã˛ã¨ã¤ãã¤åããĻããŖãã
ãįĄåšåãĢã¯åčŠĻé¨ããããã ããããĢä¸Ļãã äēæåãĢã¯åčŠĻé¨ããĒãã
ããããĻãããŽä¸čϧãŽä¸ãŽããä¸čĄã§į§ãŽįŽã¯æĸãžãŖãããããæŖįĸēã§ã¯ãĒããį§ãŽįŽãæĸãããŽã¯ãããŽä¸čĄãããŖã¨čĻã¤ããĻããäŊåãŽčĻįˇãŽãģãã ãŖãã
ãåĨŗæ§ãä¸åäēæŗãčģĸ帰ãæģäēĄã
ãå§ã¯ãĒããåŽå ¨æ§å ąåãĢæŖč ãŽæ°åã¯čŧããĒãããããĢãããŽã¯åŋååãããããã ãŽåąæ§ãŽä¸Ļãŗã ãããčĒåãĢč¨ãčãããĒããããį§ã¯įŽãããããã
ãäŊåã¯ãžã ããŽä¸čĄãčĻã¤ããĻããã
ãæĄč°ˇãããã¨åŊŧåĨŗã¯č¨ãŖããåŖ°ã¯éããĻããĒããŖããéããĻããĒããã¨ãããĄã°ãæããããŖãã
ãããŽäēēããĄã¯ãã¨åŊŧåĨŗã¯įļããããåčŠĻé¨ã§åæ ŧãããããã§äēĄããĒãŖããã§ããä¸åēĻčãåēãĻãįĄåšãĢãããĻãããä¸åēĻčŠĻé¨ããĻãåæ ŧããããŽãããã§ã
ãį§ã¯äŊãč¨ããĒããŖãã
ãåŊŧåĨŗã¯ããŽä¸čĄããįŽãéĸããĒããŖãã
ãįĄåšåãŖãĻãã¨äŊåã¯ãããããããĢč¨ãŖãããããŖããčǰãŽãããŽããŽãĒãã§ããããã
ãį§ã¯ããŽåããĢįããĒããŖããįããã°åŖ°ããã¤ããŽåŖ°ã§ãĒããĒãããã ãŖãã
ãããŽå¤į§ã¯åããĻčĒåãŽäŊãŖãįŠčĒãŽä¸ãĢãčĒåãŽįĨããĒãä¸čĄããžããčžŧãã§ãããŽãæããããåĨŗæ§ãä¸åäēæŗãæģäēĄããããŽä¸čĄã¯äēåš´åããããŖã¨ãããĢããŖããį§ãčĻãĒããŖãã ãã§ããããĻäģãããŽä¸čĄãį§ãŽåãĢåŽåãįĩãŗãį§ã¨åãįŽã§ãį§ãŽįŠčĒãčĩˇããé ãĢä¸Ļãšį´ãã¯ãããĻããã
âãâãâ
īŧįŦŦ3芹ãģäēīŧ
ãéŖčŧå芹ã¸ãŽãĒãŗã¯ã
ãģįŦŦ1芹ã æģå¯īŧINSPECTIONīŧ
ãģįŦŦ2芹ã åčŠĻé¨īŧRETESTīŧ
ãģįŦŦ4芹ãÂ æ¯æŖæĒįŊŽīŧCAPAīŧ
ãģæįĩ芹ãé¸čąīŧDEVIATIONīŧ
ãããŦã¸ãŗã
