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婊呰弻鏌滈(y脿n)璀�

1.  婊呰弻鏌滅殑妲�(g貌u)閫�

婊呰弻鏌滅殑绲�(ji茅)妲�(g貌u)涓昏鐐鸿厰楂旓紙鏌滃収(n猫i)鍙楀锛夈€佸竷姘村櫒锛堝櫞鐞冲惊鐠�(hu谩n)姘达級銆侀€�(j矛n)鍑烘枡闁€锛堝绺┖姘ｅ瘑灏佽垏闆绘(j墨)鍌冲嫊(d貌ng)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�銆佸惊鐠�(hu谩n)姘存车锛堟煖鍏�(n猫i)鐨凴O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�锛屾湰婊呰弻鏌滃寘鎷鍔涢€ｉ帠瑁濈疆銆佹韩搴﹂€ｉ帠瑁濈疆锛堝彧鏈夋煖鍏�(n猫i)娌掓湁鐩稿皪澹撳姏鍜屾韩搴﹂仈(d谩)鍒拌姹傛檪(sh铆)鎵嶈兘闁嬮杸锛夈€佹煖鍏�(n猫i)瀹夊叏闁ワ紙鐣�(d膩ng)鏌滃収(n猫i)澹撻亷澶ф檪(sh铆)鎺掔┖娉勫锛�銆佹墜鍕�(d貌ng)鎺掓按锛堟帓姘ｏ級闁ラ杸锛堢暟甯告儏娉佷笅鎺掓斁鏌滃収(n猫i)鐨勬按鍜岀┖姘ｏ級绛�銆�

2.  婊呰弻鏌滃伐浣滃師鐞�

鑴堝嫊(d貌ng)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(d貌ng)鎶藉嚭婊呰弻鏌滃鍏�(n猫i)鍐风┖姘�锛屼娇鍏惰檿浜庤矤(f霉)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�(n猫i)閮�锛屽姝ゅ弽寰�(f霉)3娆℃垨4娆�銆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�(zh矛)璁婃€у嚌鍥鸿€屾粎娲婚仈(d谩)鍒版粎鑿岃姹�?锛熷仺Y(ji茅)婊呰弻鏌滅殑鏁村€�(g猫)宸ヤ綔閬庣▼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�锛涳紙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�銆�

3.  婊呰弻鏌滅偤浠€涔堣椹�(y脿n)璀�

鍦�92鐗圵HO鐨勮(gu墨)鑼冧腑鎻愬埌鎵€鏈夎ō(sh猫)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�(j墨)锛夊潎鎳�(y墨ng)鎸夎▓(j矛)鍔冮€�(j矛n)琛岄(y脿n)璀�銆佺董璀�(h霉)鍜岀洠(ji膩n)鎺э紝浠讳綍婊呰弻鏂规硶鍦ㄦ寮忛噰鐢ㄥ墠锛岃┎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(d谩)鍒拌(gu墨)瀹氭粎鑿岃姹傞兘鎳�(y墨ng)缍�(j墨ng)閬庨(y脿n)璀�銆傛噳(y墨ng)瀹氭湡閫�(j矛n)琛屽啀椹�(y脿n)璀�锛屾瘡鐣�(d膩ng)瑷�(sh猫)鍌欐湁閲嶅ぇ鏀硅畩鏅�(sh铆)锛屼篃闋堥€�(j矛n)琛屽啀椹�(y脿n)璀�銆�

鍦�98鐗堢殑GMP鎸囧崡鍜�2002骞寸増鐨勯(y脿n)璀夋寚鍗楀拰2005骞寸殑钘ュ吀涓棞(gu膩n)浜庢粎鑿屾硶閮ㄥ垎涔熺郸鍑轰簡瑭崇窗(x矛)鐨勮姹�锛岀啊鍠绱嶇偤涓€涓嬪咕鍊�(g猫)鏂归潰锛�

锛�1锛夐爯(y霉)纰鸿獚(r猫n)锛屽皪婊呰弻鏌滅殑鍩烘湰鍔熻兘鏄惁閬�(d谩)鍒板叕鍙哥殑瑕佹眰閫�(j矛n)琛岀⒑瑾�(r猫n)銆�

锛�2锛夊畨瑁濈⒑瑾�(r猫n)锛屽寘鎷枃浠剁⒑瑾�(r猫n)銆佸湒绱欐鏌�銆佷富瑕佹(j墨)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�(sh铆)鐝�(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(y霉n)琛岀⒑瑾�(r猫n)锛屽寘鎷姛鑳芥脯瑭﹀拰鍩烘湰鎬ц兘鍙冩暩(sh霉)鐨勭⒑瑾�(r猫n)锛屼互鍙婂皪涓婅堪瀹夎纰鸿獚(r猫n)鍏�(n猫i)瀹圭殑閬�(y霉n)琛屾檪(sh铆)鍕�(d貌ng)鎱�(t脿i)纰鸿獚(r猫n)锛屽悓鏅�(sh铆)鏍规摎(j霉)瀵�(sh铆)闅涙儏娉佷慨瑷傛搷浣滆(gu墨)绋嬪拰灏嶆搷浣滀汉鍝￠€�(j矛n)琛屽(sh铆)鎿嶅煿瑷�(x霉n)銆�

锛�4锛夋€ц兘纰鸿獚(r猫n)锛屽寘鎷(y脿n)璀夊剙鍣ㄧ殑鏍￠(y脿n)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﹂(y脿n)銆傚叾涓�锛屾渶涓昏鐨勮　閲忔(bi膩o)婧�(zh菙n)鏄粎鑿岄殠娈靛喎榛�(di菐n)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(y脿n)璀�鐨勭洰鐨�

璁撴粎鑿屾煖鏇寸┅(w臎n)瀹氬湴宸ヤ綔鏄(y脿n)璀夌殑鐩殑锛岃€屼笉鏄彧闂�(gu膩n)蹇冪祼(ji茅)璜栨槸鍚﹀悎鏍�锛屾槸鍚﹀彲浠ョ敓鐢�(ch菐n)銆傞(y脿n)璀夌殑鏍稿績鎬濇兂鏄€氶亷椹�(y脿n)璀夐亷绋嬬櫦(f膩)鐝�(xi脿n)鍟忛锛屼簡瑙ｆ粎鑿屾煖鐨勫(sh铆)闅涘伐浣滅媭娉侊紙鐗瑰垾鏄瘡骞寸殑鍐嶉(y脿n)璀夋洿鏄姝わ級锛屽緸鑰岃В姹哄晱椤�锛岀偤鏃ュ悗鐨勭董璀�(h霉)鍜屾鏌ユ彁渚涗緷鎿�(j霉)鑸囧皪鐓�锛屾墠鑳界煡鏇夐€欏€�(g猫)鏌滄帶鍒舵槸鍚﹀悎鐞�銆佺簿搴﹀浣曘€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(y脿n)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�(j矛n)琛屾粎鑿岀殑瑭卞氨蹇呴爤棣栧厛灏囧寘瑁瑰収(n猫i)閮ㄧ殑绌烘埃鎶藉嚭渚�锛岀劧鍚庡皣钂告苯鎵撳叆鍒版粎鑿屽寘瑁圭殑鍏�(n猫i)閮�锛屽苟鍧囧嫽鍒嗗竷浜庡寘瑁瑰収(n猫i)鐨勫悇鍊�(g猫)閮ㄥ垎锛岀劧鍚庤捀姹芥墠鑳藉湪鐗瑰畾鐨勬韩搴﹀拰鏅�(sh铆)闁撲笅鐧�(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鍖呫€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�(y脿n)璀夐爡(xi脿ng)鐩涓嬶細

锛�1锛夊畨瑁濈⒑瑾�(r猫n)

a. 鍩硅〒(x霉n)纰鸿獚(r猫n)

b. 鍏堟焙姊濅欢纰鸿獚(r猫n)

c. 娓│鍎€鍣ㄦ牎婧�(zh菙n)纰鸿獚(r猫n)

d. 瀹夎鐠�(hu谩n)澧冪⒑瑾�(r猫n)

e. 瑷�(sh猫)鍌欓儴浠剁⒑瑾�(r猫n)

f. 鏂囦欢璩囨枡纰鸿獚(r猫n)

锛�2锛夐亱(y霉n)琛岀⒑瑾�(r猫n)

a. 閬�(y霉n)琛屽姛鑳芥搷浣滅⒑瑾�(r猫n)

b. 鍫�(b脿o)璀﹀姛鑳界⒑瑾�(r猫n)

c. BD娓│纰鸿獚(r猫n)

d. 婧害鎺у埗鍋忓樊瑭﹂(y脿n)纰鸿獚(r猫n)

e. 绌鸿級鐔卞垎甯冭│椹�(y脿n)纰鸿獚(r猫n)

锛�3锛夋€ц兘纰鸿獚(r猫n)

a. 鍩硅〒(x霉n)纰鸿獚(r猫n)

b. 鍏堟焙姊濅欢纰鸿獚(r猫n)

c. 娓│鍎€鍣ㄦ牎婧�(zh菙n)纰鸿獚(r猫n)

d. 婊胯級鐔卞垎甯冭│椹�(y脿n)纰鸿獚(r猫n)

e. 鐔辩┛閫忚│椹�(y脿n)纰鸿獚(r猫n)

f. 寰敓鐗╂寫鎴�(zh脿n)瑭﹂(y脿n)纰鸿獚(r猫n)

  鍏徃鑳屾櫙浠嬬垂锛�

鑿瓬&婢ゆ亽鏄皥娉ㄤ簬鐐虹敓鐗╁埗钘ヨ妤�(y猫)鎻愪緵瀵�(sh铆)椹�(y脿n)瀹ゅ剙鍣ㄨ▓(j矛)閲忔牎婧�(zh菙n)銆丟MP椹�(y脿n)璀夋湇鍕�(w霉)/3Q椹�(y脿n)璀�/瑷�(sh猫)鍌欑⒑瑾�(r猫n)/寤犳埧椹�(y脿n)璀夌殑灏堟キ(y猫)鏈嶅嫏(w霉)鍟嗐€傛垜鍊戠郸鍒惰棩瀹㈡埗瑙ｆ焙鐨勬槸涓€绔欏紡QC/QA/宸ョ▼/椹�(y脿n)璀夌瓑浜嬫キ(y猫)閮ㄧ殑璩�(zh矛)鎺у鍖呮湇鍕�(w霉)銆�

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