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鐢�(ch菐n)鍝�姹傝臣浼佹キ(y猫)璩囪▕鏈冨睍渚涙噳

缍�(w菐ng)绔欏公鍔�鏈珯鏈嶅嫏鐧�(f膩)甯冮噰璩�浼佹キ(y猫)寤虹珯

鐧惧垎闆堕儴浠剁恫(w菐ng)渚涙眰鍟嗘渚涙噳淇℃伅閱�(y墨)钘ョ敓鐗╃郴绲�(t菕ng)婊呰弻鏌滈璀夊収瀹规湁鍝簺

閱�(y墨)钘ョ敓鐗╃郴绲�(t菕ng)婊呰弻鏌滈璀夊収瀹规湁鍝簺

2025-03-31

鐢�(ch菐n)鍝佸湒鐗�
鐢�(ch菐n)鍦帮細
涓婃捣/涓婃捣甯�
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鏈夋晥鏈熼倓鍓�180澶�

鐢�(ch菐n)鍝�瑭虫儏

婊呰弻鏌滈璀�

1.  婊呰弻鏌滅殑妲嬮€�

婊呰弻鏌滅殑绲愭涓昏鐐鸿厰楂旓紙鏌滃収鍙楀锛夈€佸竷姘村櫒锛堝櫞鐞冲惊鐠�(hu谩n)姘达級銆侀€插嚭鏂欓杸锛堝绺┖姘e瘑灏佽垏闆绘鍌冲嫊锛�銆佺啽浜ゆ彌鍣紙宸ユキ(y猫)钂告苯鑸嘡O姘翠綔鐔辨簮锛夈€佸惊鐠�(hu谩n)姘存车锛堟煖鍏х殑RO姘寸殑寰挵(hu谩n)锛夌瓑銆傝€屾粎鑿屾煖浣滅偤澹撳姏瀹瑰櫒锛岄倓蹇呴爤鏈夊畨鍏ㄩ檮浠讹紝鏈粎鑿屾煖鍖呮嫭澹撳姏閫i帠瑁濈疆銆佹韩搴﹂€i帠瑁濈疆锛堝彧鏈夋煖鍏ф矑鏈夌浉灏嶅鍔涘拰婧害閬斿埌瑕佹眰鏅傛墠鑳介枊闁€锛�銆佹煖鍏у畨鍏ㄩ枼锛堢暥鏌滃収澹撻亷澶ф檪鎺掔┖娉勫锛�銆佹墜鍕曟帓姘达紙鎺掓埃锛夐枼闁€锛堢暟甯告儏娉佷笅鎺掓斁鏌滃収鐨勬按鍜岀┖姘o級绛�銆�

2.  婊呰弻鏌滃伐浣滃師鐞�

鑴堝嫊鐪熺┖澹撳姏钂告埃婊呰弻鏌滃叾婊呰弻鍘熺悊鏄€氶亷鐪熺┖娉靛€熷姪姘寸殑娴佸嫊鎶藉嚭婊呰弻鏌滃鍏у喎绌烘埃锛屼娇鍏惰檿浜庤矤澹撶媭鎱�(t脿i)锛岀劧鍚庤几鍏ラ=鍜岀啽钂告埃锛屼娇鍏惰繀閫熺┛閫忓埌鐗╁搧鍏ч儴锛屽姝ゅ弽寰�3娆℃垨4娆°€傚湪楂樻韩鍜岄珮澹撳姏鐨勪綔鐢ㄤ笅浣垮井鐢熺墿铔嬬櫧璩畩鎬у嚌鍥鸿€屾粎娲婚仈鍒版粎鑿岃姹�?锛熷仺Y婊呰弻鏌滅殑鏁村€嬪伐浣滈亷绋�锛屽彲灏囧叾鍒嗙偤锛氾紙1锛夋敞姘撮殠娈�锛涳紙2锛夊崌婧殠娈碉紱锛�3锛夋粎鑿岄殠娈�锛涳紙4锛夐檷婧硠澹撻殠娈碉紱锛�5锛夋竻娲楅殠娈点€�

3.  婊呰弻鏌滅偤浠€涔堣椹楄瓑

鍦�92鐗圵HO鐨勮(gu墨)鑼冧腑鎻愬埌鎵€鏈夎ō鍌欏婊呰弻鏌�銆佺┖姘i亷婵剧郴绲�(t菕ng)銆佹按铏曠悊绯荤当(t菕ng)锛堝寘鎷捀椁炬按姗燂級鍧囨噳鎸夎▓鍔冮€茶椹楄瓑銆佺董璀峰拰鐩�(ji膩n)鎺�锛屼换浣曟粎鑿屾柟娉曞湪姝e紡閲囩敤鍓�锛岃┎鏂规硶灏嶇敘(ch菐n)鍝佺殑閬╃敤鎬т互鍙婃瘡涓€瑁濊級鏂瑰紡涓嬭婊呰弻鍝佺殑鎵€鏈夐儴浣嶆槸鍚﹂仈鍒拌(gu墨)瀹氭粎鑿岃姹傞兘鎳夌稉(j墨ng)閬庨璀夈€傛噳瀹氭湡閫茶鍐嶉璀�锛屾瘡鐣惰ō鍌欐湁閲嶅ぇ鏀硅畩鏅�锛屼篃闋堥€茶鍐嶉璀�銆�

鍦�98鐗堢殑GMP鎸囧崡鍜�2002骞寸増鐨勯璀夋寚鍗楀拰2005骞寸殑钘ュ吀涓棞浜庢粎鑿屾硶閮ㄥ垎涔熺郸鍑轰簡瑭崇窗鐨勮姹�锛岀啊鍠绱嶇偤涓€涓嬪咕鍊嬫柟闈細

锛�1锛夐爯纰鸿獚锛屽皪婊呰弻鏌滅殑鍩烘湰鍔熻兘鏄惁閬斿埌鍏徃鐨勮姹傞€茶纰鸿獚銆�

锛�2锛夊畨瑁濈⒑瑾�锛屽寘鎷枃浠剁⒑瑾�銆佸湒绱欐鏌ャ€佷富瑕佹姊伴儴浠舵鏌�銆佸畨鍏ㄧ郴绲�(t菕ng)妾㈡煡銆佸叕鐢ㄧ閬撻€f帴妾㈡煡銆佸剙鍣ㄥ剙琛ㄦ鏌ュ拰鏍℃銆佹帶鍒剁郴绲�(t菕ng)纭欢閮ㄥ垎妾㈡煡銆佹帶鍒剁郴绲�(t菕ng)杌熶欢鍔熻兘瀵︾従(xi脿n)妾㈡煡銆佸倷浠跺倷鍝佺殑妾㈡煡绛�銆�

锛�3锛夐亱琛岀⒑瑾嶏紝鍖呮嫭鍔熻兘娓│鍜屽熀鏈€ц兘鍙冩暩(sh霉)鐨勭⒑瑾�锛屼互鍙婂皪涓婅堪瀹夎纰鸿獚鍏у鐨勯亱琛屾檪鍕曟厠(t脿i)纰鸿獚锛屽悓鏅傛牴鎿�(j霉)瀵﹂殯鎯呮硜淇▊鎿嶄綔瑕�(gu墨)绋嬪拰灏嶆搷浣滀汉鍝¢€茶瀵︽搷鍩硅〒銆�

锛�4锛夋€ц兘纰鸿獚锛屽寘鎷璀夊剙鍣ㄧ殑鏍¢銆佺┖杓夌啽鍒嗗竷銆佹豢杓夌啽鍒嗗竷鍙婃豢杓夌啽绌块€忕殑瑭﹂銆傚叾涓�锛屾渶涓昏鐨勮 閲忔婧栨槸婊呰弻闅庢鍐烽粸鍜屽钩鍧囨韩搴︿箣宸皬浜�0.5鈩冨拰鏈€绲侳0鍊�>8銆�

4.  婊呰弻鏌滈璀�鐨勭洰鐨�

璁撴粎鑿屾煖鏇寸┅(w臎n)瀹氬湴宸ヤ綔鏄璀夌殑鐩殑锛岃€屼笉鏄彧闂滃績绲愯珫鏄惁鍚堟牸锛屾槸鍚﹀彲浠ョ敓鐢�(ch菐n)銆傞璀夌殑鏍稿績鎬濇兂鏄€氶亷椹楄瓑閬庣▼鐧�(f膩)鐝�(xi脿n)鍟忛锛屼簡瑙f粎鑿屾煖鐨勫闅涘伐浣滅媭娉侊紙鐗瑰垾鏄瘡骞寸殑鍐嶉璀夋洿鏄姝わ級锛屽緸鑰岃В姹哄晱椤岋紝鐐烘棩鍚庣殑缍鍜屾鏌ユ彁渚涗緷鎿�(j霉)鑸囧皪鐓�锛屾墠鑳界煡鏇夐€欏€嬫煖鎺у埗鏄惁鍚堢悊銆佺簿搴﹀浣�銆佹槸鍚﹀勾涔呭け淇瓑銆�

5.  婊呰弻鏌滅偤浠€涔堝仛BD娓│

婵曠啽婊呰弻椋藉拰钂告苯鍜屼笉椋藉拰钂告苯閲嬫斁鐨勬經鐔辨湁寰堝ぇ宸垾锛岀偤浜嗛璀夋粎鑿屾煖绌烘埃绉婚櫎鑳藉姏鑰岃獣鐢熶簡BD娓│銆傚鏋滆灏嶅叾閫茶婊呰弻鐨勮┍灏卞繀闋堥鍏堝皣鍖呰9鍏ч儴鐨勭┖姘f娊鍑轰締锛岀劧鍚庡皣钂告苯鎵撳叆鍒版粎鑿屽寘瑁圭殑鍏ч儴锛屽苟鍧囧嫽鍒嗗竷浜庡寘瑁瑰収鐨勫悇鍊嬮儴鍒�锛岀劧鍚庤捀姹芥墠鑳藉湪鐗瑰畾鐨勬韩搴﹀拰鏅傞枔涓嬬櫦(f膩)鎻叾婊呰弻鍔熻兘銆傛墍浠ョ偤浜嗚瓑鏄庢粎鑿屾煖绌烘埃绉婚櫎鑳藉姏鑰岃獣鐢熶簡BD鍖�銆侭D鍖呮斁鍦ㄨ厰楂斿彲鐢ㄦ粎鑿岀┖闁撶殑骞句綍涓績杌哥窔涓�锛岃窛闆㈣厰楂斿簳骞抽潰100--200mm鐨勯珮搴︼紝鐢盉D娓│鏀灦鏀拹銆�

6.  婊呰弻鏌滅殑椹楄瓑闋呯洰濡備笅锛�

锛�1锛夊畨瑁濈⒑瑾�

a. 鍩硅〒纰鸿獚

b. 鍏堟焙姊濅欢纰鸿獚

c. 娓│鍎€鍣ㄦ牎婧栫⒑瑾�

d. 瀹夎鐠�(hu谩n)澧冪⒑瑾�

e. 瑷倷閮ㄤ欢纰鸿獚

f. 鏂囦欢璩囨枡纰鸿獚

锛�2锛夐亱琛岀⒑瑾�

a. 閬嬭鍔熻兘鎿嶄綔纰鸿獚

b. 鍫辫鍔熻兘纰鸿獚

c. BD娓│纰鸿獚

d. 婧害鎺у埗鍋忓樊瑭﹂纰鸿獚

e. 绌鸿級鐔卞垎甯冭│椹楃⒑瑾�

锛�3锛夋€ц兘纰鸿獚

a. 鍩硅〒纰鸿獚

b. 鍏堟焙姊濅欢纰鸿獚

c. 娓│鍎€鍣ㄦ牎婧栫⒑瑾�

d. 婊胯級鐔卞垎甯冭│椹楃⒑瑾�

e. 鐔辩┛閫忚│椹楃⒑瑾�

f. 寰敓鐗╂寫鎴�(zh脿n)瑭﹂纰鸿獚

婊呰弻鏌滈璀�

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鎴戝€戞椿韬嶄簬瑷卞闂滈嵉甯傚牬闋樺煙锛屽緸绱拌優/鍩哄洜娌荤檪闋樺煙銆佹姉楂旇棩鏂瑰悜銆佸共绱拌優娌荤檪鍒扮柅鑻楃敓鐢�(ch菐n)绛夌敓鐗╁埗钘ラ牁鍩�锛屼竴鐩翠互渚嗛兘鏄湇绻炵敓鐗╅啱(y墨)钘ュ鎴跺鐝�(xi脿n)璁撯€滆畵鍒惰棩楂旂郴鏇村畨鍏�"鐐轰娇鍛�锛屾彁楂樻湇鍕欑殑鏁堢巼銆侀檷浣庤妤�(y猫)鐨勬垚鏈�銆佽笎琛屽ソ鐨勫鎴舵湇鍕欓珨椹椼€傝嚜涓诲搧鐗岋細鑿瓬锛堜笂娴凤級妾㈡脯鎶€琛撴湁闄愬叕鍙�銆佹兢鎭掕▓閲忔娓紙鍖椾含锛夋湁闄愬叕鍙�銆�



 

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