鏃ュ寲鐢ㄥ搧鍑堝寲杌婇枔瑁濅慨瑷�(sh猫)瑷堟柟妗�-娲楁墜娑层€佹礂琛ｆ恫鐢熺敘(ch菐n)杌婇枔瑁濅慨瑷�(sh猫)瑷�
2銆佸│濂崇稉(j墨ng)鏈熻(w猫i)鐢熺敤鍝侊紙琛�(w猫i)鐢熷肪銆佽(w猫i)鐢熻(h霉)澧�銆佽(w猫i)鐢熸爴锛�锛�
3銆佸翱甯冪瓑鎺掓硠鐗╄(w猫i)鐢熺敤鍝乕灏胯げ銆佸翱甯冿紙澧�銆佺礄锛�銆侀殧灏垮]锛�
4銆佺毊鑶�銆侀粡鑶滆(w猫i)鐢熺敤鍝侊紙婵曠礄宸�銆佽(w猫i)鐢熸繒绱欏肪锛�
5銆侀毐褰㈢溂閺¤(h霉)鐞嗙敤鍝侊紙闅卞舰鐪奸彙璀�(h霉)鐞嗘恫銆侀毐褰㈢溂閺′繚瀛樻恫銆侀毐褰㈢溂閺℃竻娼斿姂锛夛紱
6銆佸│绉戣(w猫i)鐢熺敤鍝侊紙濂冲＋鎶�/鎶戣弻娲楀姂銆侀櫚閬撴礂娑诧級
7銆佸叾浠栫殑涓€娆℃€ц(w猫i)鐢熺敤鍝侊紙绱欏肪绱欍€佽(w猫i)鐢熸銆佸寲濡濇/绱�/宸俱€佹墜/鎸囧 銆佸彛缃┿€佺礄璩�(zh矛)椁愰２鍏�銆侀伩瀛曞锛�
GMP杌婇枔鏈夊暐瑕佹眰?GMP杌婇枔瑕�(gu墨)鑼冭姹傚涓嬶細
1銆佸湪娼斿噲鍗€(q奴)宸ヤ綔鐨勪汉鍝�(鍖呮嫭娓呮綌宸ュ拰瑷�(sh猫)鍌欑董淇伐)鎳�(y墨ng)鐣�(d膩ng)瀹氭湡鍩硅〒(x霉n)锛屼娇鐒¤弻鐢�(ch菐n)鍝佺殑鎿嶄綔绗﹀悎瑕佹眰銆�
2銆佹湭鍙楀煿瑷�(x霉n)鐨勫閮ㄤ汉鍝�(濡傚閮ㄦ柦宸ヤ汉鍝℃垨缍慨浜哄摗)鍦ㄧ敓鐢�(ch菐n)鏈熼枔闇€閫�(j矛n)鍏ユ綌鍑堝崁(q奴)鏅傦紝鎳�(y墨ng)鐣�(d膩ng)灏嶄粬鍊戦€�(j矛n)琛岀壒鍒ヨ┏绱�(x矛)鐨勬寚灏�(d菐o)鍜岀洠(ji膩n)鐫�銆�
3銆佸湪娼斿噲鍗€(q奴)鍏�(n猫i)閫�(j矛n)琛岃ō(sh猫)鍌欑董淇檪锛屽娼斿噲搴︽垨鐒¤弻鐙€鎱�(t脿i)閬埌鐮村锛屾噳(y墨ng)鐣�(d膩ng)灏嶈┎鍗€(q奴)鍩熼€�(j矛n)琛屽繀瑕佺殑娓呮綌銆佹秷姣掓垨婊呰弻锛屽緟鐩�(ji膩n)娓悎鏍兼柟鍙噸鏂伴枊濮嬬敓鐢�(ch菐n)鎿嶄綔銆�
4銆佺敓鐢�(ch菐n)瑷�(sh猫)鍌欐噳(y墨ng)鐣�(d膩ng)鍦ㄧ⒑瑾�(r猫n)鐨勫弮鏁�(sh霉)鑼冨湇鍏�(n猫i)浣跨敤銆�
5銆佺敤浜庣敓鐢�(ch菐n)鎴栨椹楃殑瑷�(sh猫)鍌欏拰鍎€鍣�锛屾噳(y墨ng)鐣�(d膩ng)鏈変娇鐢ㄦ棩蹇�锛岃閷勫収(n猫i)瀹瑰寘鎷娇鐢�銆佹竻娼�銆佺董璀�(h霉)鍜岀董淇儏娉佷互鍙婃棩鏈�銆佹檪闁撱€佹墍鐢熺敘(ch菐n)鍙婃椹楃殑鐢�(ch菐n)鍝佸悕绋卞拰鎵硅櫉绛�銆�
6銆侀櫎浜嗗皪瑷�(sh猫)鍌欎繚椁�(y菐ng)澶�锛屾洿閲嶈鐨勭洰鐨勬槸闃叉浜ゅ弶姹℃煋銆傚洜姝�锛屾瘡娆′娇鐢ㄥ畬鎴栦娇鐢ㄥ墠閮借灏嶈ō(sh猫)鍌欓€�(j矛n)琛屾竻娼斿拰娑堟瘨锛岀⒑淇濈鍚堣唱(zh矛)閲忔(bi膩o)婧�(zh菙n)銆�
7銆侀€�(j矛n)鍏ユ綌鍑堝崁(q奴)鐨勭墿鏂欏繀闋堝皪鍏跺鍖呰铏曠悊銆傚繀瑕佹檪锛岄倓鎳�(y墨ng)鐣�(d膩ng)閫�(j矛n)琛屾竻娼斻€佹秷姣�锛岀櫦(f膩)鐝�(xi脿n)澶栧寘瑁濇悕澹炴垨鍏朵粬鍙兘褰遍熆鐗╂枡璩�(zh矛)閲忕殑鍟忛锛屾噳(y墨ng)鐣�(d膩ng)鍚戣唱(zh矛)閲忕鐞嗛儴闁€鍫卞憡骞堕€�(j矛n)琛岃(di脿o)鏌ュ拰瑷橀寗銆�
8銆佺洓瑁濈敘(ch菐n)鍝佸強鐗╂枡鐨勫鍣ㄥ叿蹇呴爤鏄稉(j墨ng)閬庢秷姣掓粎鑿岀殑銆�
9銆佺墿鏂欏繀闋堟椹楀悎鏍煎悗鏂瑰彲浠ヤ娇鐢ㄣ€�
10銆佺墿鏂欑櫦(f膩)鏀句娇鐢ㄦ噳(y墨ng)鐣�(d膩ng)绗﹀悎鍏堥€�(j矛n)鍏堝嚭鍜岃繎鏁堟湡鍏堝嚭鐨勫師鍓�銆�
11銆佺墿鏂欐噳(y墨ng)鐣�(d膩ng)鎸夌収鏈夋晥鏈熻帛瀛�銆傝帛瀛樻湡鍏�(n猫i)锛屽鐧�(f膩)鐝�(xi脿n)灏嶈唱(zh矛)閲忔湁涓嶈壇褰遍熆鐨勭壒娈婃儏娉�锛屾噳(y墨ng)鐣�(d膩ng)閫�(j矛n)琛屽京(f霉)銆�
12銆佸皪婧害銆佹繒搴︽垨鍏跺畠姊濅欢鏈夌壒娈婅姹傜殑鐗╂枡鎳�(y墨ng)鎸夎(gu墨)瀹氭浠跺劜瀛樸€�
13銆佹枃浠舵噳(y墨ng)鐣�(d膩ng)鍒嗛瀛樻斁銆佹鐞嗗垎鏄�锛屼究浜庢煡闁�銆�
14銆佸師鐗堟枃浠跺京(f霉)鍒舵檪锛屼笉寰楃敘(ch菐n)鐢熶换浣曞樊閷�;寰�(f霉)鍒剁殑鏂囦欢鎳�(y墨ng)鐣�(d膩ng)娓呮櫚鍙鲸銆�
15銆佸垎鐧�(f膩)銆佷娇鐢ㄧ殑鏂囦欢鎳�(y墨ng)鐣�(d膩ng)鐐烘壒婧�(zh菙n)鐨勭従(xi脿n)琛屾枃鏈紝宸叉挙閵风殑鎴栬垔鐗堟枃浠堕櫎鐣欐獢鍌欐煡澶�锛屼笉寰楀湪宸ヤ綔鐝�(xi脿n)鍫村嚭鐝�(xi脿n)銆�
16銆佽垏鏈(gu墨)鑼冩湁闂�(gu膩n)鐨勬瘡闋呮椿鍕曞潎鎳�(y墨ng)鐣�(d膩ng)鏈夎閷�锛屼互淇濊瓑鐢�(ch菐n)鍝佺敓鐢�(ch菐n)銆佽唱(zh矛)閲忔帶鍒跺拰璩�(zh矛)閲忎繚璀夌瓑娲诲嫊鍙互杩芥函銆傝閷勬噳(y墨ng)鐣�(d膩ng)鐣欐湁濉鏁�(sh霉)鎿�(j霉)鐨勮冻澶犵┖鏍�銆傝閷勬噳(y墨ng)鐣�(d膩ng)鍙婃檪濉锛屽収(n猫i)瀹圭湡瀵�锛屽瓧璺℃竻鏅�銆佹槗璁€锛屼笉鏄撴摝闄�銆�
17銆佽閷勬噳(y墨ng)鐣�(d膩ng)淇濇寔娓呮綌锛屼笉寰楁挄姣€鍜屼换鎰忔秱鏀�銆傝閷勫～瀵殑浠讳綍鏇存敼閮芥噳(y墨ng)鐣�(d膩ng)绨芥敞濮撳悕鍜屾棩鏈燂紝骞朵娇鍘熸湁淇℃伅浠嶆竻鏅板彲杈�锛屽繀瑕佹檪锛屾噳(y墨ng)鐣�(d膩ng)瑾槑鏇存敼鐨勭悊鐢�銆傜敓鐢�(ch菐n)鍜屾椹楃殑瑷橀寗鎳�(y墨ng)鍙婃檪姝告獢銆�
18銆佷笉鍚岀┖姘ｆ綌鍑堝害绛夌礆浣跨敤鐨勫伐浣滄湇鎳�(y墨ng)鍒嗗垾娓呮礂銆佹暣鐞�锛屽繀瑕佹檪娑堟瘨鎴栨粎鑿�銆傚伐浣滄湇娲楁粚銆佹粎鑿屾檪涓嶆噳(y墨ng)甯跺叆闄勫姞鐨勯绮掔墿璩�(zh矛)銆傚伐浣滄湇鎳�(y墨ng)鍒跺畾娓呮礂鍛ㄦ湡銆�
19銆佸偝鏌撶梾鎮ｈ€�銆佺毊鑶氱梾鎮ｈ€�銆侀珨琛ㄦ湁鍌疯€呬笉鑳藉緸浜嬬洿鎺ユ帴瑙哥敘(ch菐n)鍝佺殑鎿嶄綔銆�
20銆侀€�(j矛n)鍏ユ綌鍑堝崁(q奴)鐨勪汉鍝′笉寰楀寲濡濆拰浣╁付椋剧墿(濡傛墜姗�(j墨))銆�
21銆佺敓鐢�(ch菐n)閬庣▼涓毃鏅備繚鎸佺従(xi脿n)鍫寸殑琛�(w猫i)鐢熷伐浣�锛屼笉寰楀嚭鐝�(xi脿n)鑷�銆佷簜銆佸樊鐨勫牬闈�銆�
22銆佸緸浜嬬劇鑿岃棩鍝佺敓鐢�(ch菐n)鐨勫摗宸ユ噳(y墨ng)鐣�(d膩ng)闅ㄦ檪鍫卞憡浠讳綍鍙兘灏�(d菐o)鑷存薄鏌撶殑鐣板父鎯呮硜锛屽寘鎷薄鏌撶殑椤炲瀷鍜岀▼搴︺€傜暥(d膩ng)鍝″伐鐢变簬鍋ュ悍鐙€娉佸彲鑳藉皫(d菐o)鑷村井鐢熺墿姹℃煋棰�(f膿ng)闅澶ф檪锛屾噳(y墨ng)鐣�(d膩ng)鐢卞皥妤�(y猫)鐨勪汉鍝￠噰鍙栭仼鐣�(d膩ng)?sh霉)鎷囪儳顭�?/p>
23銆佹綌鍑堝崁(q奴)鍙婃椹楀崁(q奴)绂佹鍚哥厵鍜岄２椋�锛岀姝㈠瓨鏀鹃鍝�銆侀２鏂�銆侀鐓欏拰鍊嬩汉鐢ㄥ搧绛夐潪鐢熺敘(ch菐n)鐢ㄧ墿鍝�銆�
24銆佽椁�(y菐ng)鎴愯壇濂界殑琛�(w猫i)鐢熺繏(x铆)鎱�锛屽仛鍒板嫟娲楁尽銆佸嫟娲楁墜銆佸嫟鍒儭瀛�銆佸嫟鍓寚鐢�銆佸嫟鎻涜。銆�
25銆佷笉寰楄８鎵嬬洿鎺ユ帴瑙哥敘(ch菐n)鍝佷互鍙婅ō(sh猫)鍌�銆傛噳(y墨ng)鐣�(d膩ng)鎸夌収鎿嶄綔瑕�(gu墨)绋嬫洿琛ｅ拰娲楁墜锛岀洝鍙兘娓涘皯灏嶆綌鍑堝崁(q奴)鐨勬薄鏌撴垨?q奴)鈶藉淮鐤氶５顬﹂湜宕堥瓲^(q奴)銆�
26銆佺暥(d膩ng)鐒¤弻鐢熺敘(ch菐n)姝ｅ湪閫�(j矛n)琛屾檪锛屾噳(y墨ng)鐣�(d膩ng)鐗瑰垾娉ㄦ剰娓涘皯娼斿噲鍗€(q奴)鍏�(n猫i)鐨勫悇绋椿鍕曘€傛噳(y墨ng)鐣�(d膩ng)娓涘皯浜哄摗璧板嫊锛岄伩鍏嶅妵鐑堟椿鍕曟暎鐧�(f膩)閬庡鐨勫井绮掑拰寰敓鐗┿€�
27銆佷换浣曢€�(j矛n)鍏ョ敓鐢�(ch菐n)鍗€(q奴)鐨勪汉鍝″潎鎳�(y墨ng)鐣�(d膩ng)鎸夌収瑕�(gu墨)瀹氭洿琛�銆傛瘡浣嶅摗宸ユ瘡娆￠€�(j矛n)鍏ユ綌鍑堝崁(q奴)锛屾噳(y墨ng)鐣�(d膩ng)鏇存彌鐒¤弻宸ヤ綔鏈�;鎴栨瘡鐝嚦灏戞洿鎻涗竴娆�銆�
28銆佹搷浣滄湡闁撴噳(y墨ng)鐣�(d膩ng)缍�(j墨ng)甯告秷姣掓墜濂�锛屽苟鍦ㄥ繀瑕佹檪鏇存彌鍙ｇ僵鍜屾墜濂�銆�
29銆佹竻娼斿ぉ鑺辨澘銆佸⒒澹�銆佽垏澧诲閫ｆ帴鐨勭墿楂�銆佺閬�銆佽嚭闈�銆佽ō(sh猫)鍌欍€佸湴闈�銆傚厛涓婂悗涓�銆佸厛閲屽悗澶�銆佸厛娓呮礂銆佸啀娓呮綌銆佸悗娑堟瘨锛屼笉瑕佸湪娓呮綌閬庣殑鍦伴潰涓婅蛋鍕�銆�
30銆佹噳(y墨ng)鐣�(d膩ng)鎸夌収鎿嶄綔瑕�(gu墨)绋嬪皪娼斿噲鍗€(q奴)閫�(j矛n)琛屾竻娼斿拰娑堟瘨銆備竴鑸儏娉佷笅锛屾墍閲囩敤娑堟瘨鍔戠殑绋鎳�(y墨ng)鐣�(d膩ng)澶氫簬涓€绋紝姣忔湀杓彌浣跨敤銆備笉寰楃敤绱绶氭秷姣掓浛浠ｅ寲瀛�(xu茅)娑堟瘨銆傛噳(y墨ng)鐣�(d膩ng)瀹氭湡閫�(j矛n)琛岀挵(hu谩n)澧冪洠(ji膩n)娓�锛屽強鏅傜櫦(f膩)鐝�(xi脿n)鑰愬彈鑿屾牚鍙婃薄鏌撴儏娉�銆�
31銆佹噳(y墨ng)鐣�(d膩ng)鐩�(ji膩n)娓秷姣掑姂鍜屾竻娼斿姂鐨勫井鐢熺墿姹℃煋鐙€娉�锛岄厤鍒跺悗鐨勬秷姣掑姂鍜屾竻娼斿姂鎳�(y墨ng)鐣�(d膩ng)瀛樻斁鍦ㄦ竻娼斿鍣ㄥ収(n猫i)锛岀従(xi脿n)鐢ㄧ従(xi脿n)閰�銆侫绱氭綌鍑堝崁(q奴)鎳�(y墨ng)鐣�(d膩ng)浣跨敤鐒¤弻鐨勬垨缍�(j墨ng)鐒¤弻铏曠悊鐨勬秷姣掑姂鍜屾竻娼斿姂銆�
32銆佹綌鍑堝崁(q奴)鍏�(n猫i)鎳�(y墨ng)鐣�(d膩ng)閬垮厤浣跨敤鏄撹劔钀界簴缍殑瀹瑰櫒鍜岀墿鏂�;鍦ㄧ劇鑿岀敓鐢�(ch菐n)鐨勯亷绋嬩腑锛屼笉寰椾娇鐢ㄦ椤炲鍣ㄥ拰鐗╂枡銆�
