婀栧崡甯寖澶у纰╁＋鐮旂┒鐢熷叆瀛歌€冭│鑷懡椤岃€冭│澶х侗

鑰冭│绉戠洰浠ｇ⒓[    ]               鑰冭│绉戠洰鍚嶇ū锛氱窗鑳炵敓鐗╁

涓€銆佽€冭│鍏у鑸囪€冭│瑕佹眰

绱拌優鐢熺墿瀛�

锛堜竴锛夌窗鑳炵祼妲�銆佸姛鑳�

鑰冭│鍏у锛�

1銆佺窗鑳炵敓鐗╁鍩烘湰姒傚康

绱拌優鏄敓鐗╅珨鐨勫熀鏈祼妲嬪柈浣�锛岀窗鑳炵敓鐗╁鏄敓鍛界瀛哥殑鍒嗘敮锛屼互绱拌優鐐虹爺绌跺皪璞�锛屾彮绀虹敓鐗╅珨鐢熼暦鐧�(f膩)鑲层€佸垎鍖�銆佽“鑰佸拰姝讳骸鐨勮(gu墨)寰�銆�

鑰冭│瑕佹眰锛�

(1) 鎺屾彙绱拌優鐢熺墿瀛哥殑姒傚康

(2) 浜嗚В绱拌優鐢熺墿瀛哥櫦(f膩)灞曡定鍕㈣垏閲嶉粸闋樺煙

(3) 浜嗚В绱拌優鐢熺墿瀛哥殑鐧�(f膩)灞曠啊鍙�

2銆� 绱拌優鐢熺墿瀛哥爺绌舵柟娉�

鑰冭│鍏у

绱拌優鐢熺墿瀛哥殑鐧�(f膩)灞曞緢澶х▼搴︿緷璩翠簬鐮旂┒鎶€琛撶殑閫叉鑸囧剙鍣ㄨō鍌欑殑鏀归€�锛岀窗鑳炵敓鐗╁鐨勬妧琛撳緢澶�锛屽師鐞嗗拰鎿嶄綔姝ラ鍚勪笉鐩稿悓锛屾湁绱拌優鐨勫舰鎱�(t脿i)瑙€瀵�銆佺窗鑳炵殑鍒嗛洟鍜屽煿椁�(y菐ng)銆佺窗鑳炵殑绲勫垎鐨勫垎闆㈢磾鍖栧拰娓畾绛�銆�

鑰冭│瑕佹眰锛�

锛�1锛夋帉鎻″咕绋父鐢ㄥ厜瀛搁’寰彙鐨勪娇鐢ㄥ師鐞嗗強鏂规硶锛�

    锛�2锛夋帉鎻＄窗鑳炶瀺鍚堢殑姒傚康鍜屽熀鏈柟娉�锛�

    锛�3锛変簡瑙ｅ樊閫熼洟蹇冩硶鍜屽瘑搴︽搴﹂洟蹇冩硶鐨勬蹇靛拰鏂规硶銆�

锛�4锛変簡瑙ｆ斁灏勮嚜椤奖鑸囧厤鐤’寰彙鎶€琛撱€�

锛�5锛変簡瑙NA搴忓垪鍒嗘瀽鑸囨牳閰稿垎瀛愰洔浜�銆�

3銆佺窗鑳炶啘鍙婄墿璩殑璺ㄨ啘閬嬭几

鑰冭│鍏у

 绱拌優鑶滀笉鏄竴绋姊板睆闅滐紝瀹冧笉鍍呯偤绱拌優鐨勭敓鍛芥椿鍕曟彁渚涗簡绌�(w臎n)瀹氱殑鍏х挵(hu谩n)澧冿紝閭勮浣胯憲鐗╄唱杞夐亱銆佷俊铏熷偝閬�銆佺窗鑳炶瓨鍒ョ瓑澶氱ó寰╅洔鍔熻兘锛屽苟涓旇垏鐢熷懡绉戝涓殑瑷卞鍩烘湰鍟忛瀵嗗垏鐩搁棞銆傚洜姝�锛屾纰鸿獚璀樼窗鑳炶啘鐨勭祼妲嬭垏鍔熻兘灏嶆彮绀虹敓鍛芥椿鍕曠殑濂х鍏锋湁閲嶈鎰忕京銆傚柈浣嶈啘銆佺窗鑳炶啘銆佺敓鐗╄啘銆佽剛璩珨銆佽啘杞夐亱铔嬬櫧

鑰冭│瑕佹眰

锛�1锛夌啛鎮夌窗鑳炶啘鐨勫垎瀛愮祼妲嬫ā鍨嬬殑椤炲瀷鍜岃榛炲拰娑叉厠(t脿i)閼插祵妯″瀷

锛�2锛夌啛鎮夌窗鑳炶啘鐨勫寲瀛哥祫鎴愬強鍚勭祫鍒嗙殑鍒嗗瓙绲愭鐗归粸鍙婂叾鍔熻兘

锛�3锛夋帉鎻＄窗鑳炶啘鐨勪笉灏嶇ū鎬у拰娴佸嫊鎬�

锛�4锛夋帉鎻＄墿璩殑璺ㄨ啘閬嬭几

4銆佺窗鑳炴牳鑸囬伜鍌充俊鎭殑娴佸悜

鑰冭│鍏у

绱拌優鏍告槸鐪熸牳绱拌優鍏ф渶澶х殑绱拌優鍣�锛屾槸閬哄偝鐗╄唱鍎插瓨銆佸京鍒跺拰杞夐寗鐨勫牬鎵€锛屾槸绱拌優鐢熷懡娲诲嫊鐨勬帶鍒朵腑蹇�銆傛牳瀛斿京鍚堥珨銆佽Κ鏍歌泲鐧�銆佹牳瀹氫綅淇¤櫉銆佸父鏌撹壊璩垏鐣版煋鑹茶唱銆佹牳浠佺祫绻旇€�

鑰冭│瑕佹眰

锛�1锛夋帉鎻℃牳琚啘鐨勭祼妲嬬祫鎴�锛�

锛�2锛夌啛鎮夋牳瀛斿京鍚堥珨鐨勭祼妲嬫ā鍨�锛�

锛�3锛夋帉鎻℃牳瀛斿京鍚堥珨浣滅偤闆欏悜瑕按鎬ч€氶亾鎵€浠嬪皫鐨勭墿璩亱杓稿姛鑳姐€�

锛�4锛夋帉鎻℃煋鑹茶唱鐨勬蹇靛苟浜嗚В鏌撹壊璩殑鍖栧绲勬垚锛�

锛�5锛夋帉鎻℃牳浠佺殑鍖栧绲勬垚锛涙牳浠佺殑瓒呭井绲愭鍜屽姛鑳�

5銆佺窗鑳為鏋�

鑰冭│鍏у

绱拌優楠ㄦ灦鏄湡鏍哥窗鑳炶唱涓殑铔嬬櫧璩簴缍恫(w菐ng)鏋堕珨绯�锛屽皪绱拌優鐨勫舰鎱�(t脿i)銆佺窗鑳炵殑閬嬪嫊銆佺窗鑳炲収鐗╄唱鐨勯亱杓搞€佹煋鑹查珨鐨勫垎闆㈠拰绱拌優鍒嗚绛夎捣钁楅噸瑕佺殑浣滅敤銆傝笍杌婅鐐�銆佸井瑙€绲勭箶涓績銆佸井绠″拰寰挡鐨勭壒鐣版€ц棩鐗┿€佷笁绋窗鑳為鏋剁殑绲勬垚銆佸舰鎱�(t脿i)鐗瑰緛銆佸姛鑳�

鑰冭│瑕佹眰

锛�1锛夋帉鎻＄窗鑳為鏋剁殑姒傚康 

    锛�2锛夋帉鎻″井绲茬殑鍖栧绲勬垚銆佺祼妲嬬祫瑁�銆佸姛鑳�銆佸垎甯�銆佺祼鍚堣泲鐧藉強褰遍熆寰挡绲勮鐨勫洜绱�

锛�3锛夋帉鎻″井绠＄殑鍖栧绲勬垚銆佺祼妲嬬祫瑁�銆佸井绠＄殑鍔熻兘銆佸奖闊垮井绠＄祫瑁濈殑鍥犵礌銆佸井绠＄祼鍚堣泲鐧�

锛�4锛夌啛鎮夌簴姣涳紟闉瘺鐨勮秴寰祼妲嬭垏鍔熻兘锛�

锛�5锛夌啛鎮変腑闁撶簴缍殑鍒嗗竷銆佺祼妲嬭垏绲勮銆佺祼鍚堣泲鐧�

 锛�6锛夋帉鎻′笁绋優璩鏋朵箣闁撶殑鍏辨€у拰鐗瑰緛銆佺浉浜掑崝(xi茅)瑾垮強鍏朵粬绱拌優鍣ㄧ殑闂滅郴

6銆佺窗鑳炵殑鍏ц啘绯荤当(t菕ng) 

鑰冭│鍏у

鍏ц啘绯荤当(t菕ng)鏄窗鑳炲収閭ｄ簺鍦ㄧ祼妲�銆佸姛鑳藉強鍏剁櫦(f膩)鐢熶笂鐩镐簰瀵嗗垏闂滆伅(li谩n)鐨勮啘鎬х祼妲嬬窗鑳炲櫒鐨勭附绋便€備富瑕佸寘鎷細鍏ц唱缍�(w菐ng)銆侀珮鐖惧熀寰╁悎楂�銆佹憾閰堕珨銆佸悇绋綁閬嬪皬娉′互鍙婃牳鑶滅瓑鍔熻兘绲愭銆傚井绮掗珨銆佷俊铏熻偨鍋囪銆佸悇鍏ц啘绯荤当(t菕ng)绲勬垚鐨勬蹇楅叾

鑰冭│瑕佹眰

锛�1锛夋帉鎻℃牳绯栭珨鐨勫熀鏈鍨嬭垏鎴愬垎銆佺祼妲�銆佽垏铔嬬櫧璩悎鎴愭湁闂滅殑涓昏娲绘€ч儴

锛�2锛夋帉鎻℃牳绯栭珨鍦ㄨ泲鐧借唱鍚堟垚涓殑浣滅敤锛�

锛�3锛夋帉鎻″収璩恫(w菐ng)鐨勫舰鎱�(t脿i)绲愭鍙婇鍨�銆佸姛鑳姐€佽泲鐧借唱鍚堟垚鐨勪俊铏熻偨鍋囪銆傚叾浠栫窗鑳炲櫒鐨勯棞绯�

锛�4锛夋帉鎻￠珮鐖惧熀寰╁悎楂旂殑褰㈡厠(t脿i)绲愭鐗瑰緛銆佸寲瀛哥祫鎴愬強涓昏閰堕銆佸姛鑳�銆侀珮鐖惧熀楂斿湪绱拌優鍏ц啘娉￠亱杓镐腑鐨勪綔鐢�銆�

锛�5锛夋帉鎻℃憾閰堕珨鐨勭壒鎬�銆侀鍨嬪強鍔熻兘銆佸舰鎴愰亷绋嬪強鐩搁棞閰堕銆佽垏鐤剧梾鐨勯棞绯�锛�

锛堜簩锛夌窗鑳炵敓鐗╂椿鍕�

1銆佺窗鑳炵敓闀枫€佸垎瑁傚拰绱拌優鍛ㄦ湡

鑰冭│鍏у

绱拌優鍒嗚鏄窗鑳炵敓鍛芥椿鍕曠殑閲嶈鐗瑰緛涔嬩竴锛屾槸涓€鍊嬭Κ浠ｇ窗鑳炲舰鎴愬叐鍊嬪瓙浠ｇ窗鑳炵殑閬庣▼銆傜窗鑳炲垎瑁傛槸鍛ㄦ湡鎬ч€茶鐨�锛屽悇鍊嬫椹熼€茬▼鏄彲浠ヨ鎺х殑锛屾暣鍊嬬窗鑳炲懆鏈熸槸楂樺害鐨勬檪绌烘湁搴忔€у拰鍗�(xi茅)鍚屾€х殑銆傛湁绲插垎瑁�銆佹笡鏁�(sh霉)鍒嗚銆佺窗鑳炲懆鏈�銆佹垚鐔熶績閫插洜瀛�銆佺窗鑳炲懆鏈熻泲鐧�銆佺檶鍩哄洜銆佹姂鐧屽熀鍥�

鑰冭│瑕佹眰

锛�1锛夋帉鎻＄窗鑳炲娈栫殑鏂瑰紡銆�

锛�2锛夋帉鎻＄窗鑳炲懆鏈熺殑姒傚康锛涚窗鑳炲懆鏈熺殑鍒嗘湡锛涘悇鏅傜浉鐨勪富瑕佺敓鍖栨椿鍕�锛汫1鏈熺窗鑳炰笁绋定鍚�锛�

锛�3锛夋帉鎻℃湁绲插垎瑁傜殑鍩烘湰閬庣▼鍙婃閬庣▼涓煋鑹查珨閬嬪嫊鐨勫嫊鍔涙鍒讹紱

锛�4锛夌啛鎮夌敓娈栫窗鑳炵殑鐧�(f膩)鐢熼亷绋嬪強娓涙暩(sh霉)鍒嗚鐨勭敓鐗╁鎰忕京銆�

锛�5锛夋帉鎻＄敓闀峰洜瀛�銆佹姂绱犮€佺挵(hu谩n)鏍歌嫹閰�銆侀垼瑾跨礌銆佺窗鑳炲垎瑁傚懆鏈熷熀鍥�銆佸師鐧屽熀鍥犮€佹姉鐧屽熀鍥�銆傜窗鑳炲懆鏈熸帶鍒剁郴绲�(t菕ng)绛夊皪绱拌優鍛ㄦ湡鐨勮鎺т綔鐢�锛�

锛�6锛夌啛鎮夊悇瑾挎帶鍥犲瓙鐨勮绡€(ji茅)姗熺悊銆�

2銆佺窗鑳炵殑淇¤櫉杞夊皫

鑰冭│鍏у

澶氱窗鑳炵敓鐗╁€嬮珨鐨勭窗鑳炴瘡鏅傛瘡鍒婚兘鍦ㄦ帴鍙楀拰铏曠悊渚嗚嚜鑳炲収鍙婅優澶栫殑鍚勭ó淇¤櫉锛岄€欎簺绱拌優淇¤櫉鐨勫偝閬炲拰鏁村悎鍦ㄧ敓鍛戒腑鍏锋湁閲嶈浣滅敤锛屽畠涓嶅儏褰遍熆绱拌優鏈韩鐨勬椿鍕曡€屼笖浣垮柈鍊嬬窗鑳炲湪浠ｈ瑵銆侀亱鍕�銆佸娈栧拰鍒嗗寲绛夎鐐轰笂鑸囩窗鑳炵兢鍙婃楂旂殑鏁撮珨娲诲嫊淇濇寔鍗�(xi茅)瑾夸竴鑷�銆傚彈楂斻€佸彈楂旂殑绋銆佸彈楂旂殑鐗归粸銆乧AMP淇′娇楂旂郴銆乧GMP淇′娇楂旂郴

鑰冭│瑕佹眰

锛�1锛変簡瑙ｇ窗鑳炲淇¤櫉绋锛屽彈楂旂殑姒傚康銆�

锛�2锛夋帉鎻″彈楂旂ó椤炲強鐗归粸鍙婁粙灏庣殑淇¤櫉杞夊皫

锛�3锛夌啛鎮塆铔嬬櫧鍋惰伅(li谩n)鐨勪俊铏熻綁灏�