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鍙嬫儏鎻愮ず锛氭湰绔欐彁渚涘叏鍦�400澶氭墍楂樼瓑闄㈡牎鎷涙敹纰╁＋銆佸崥澹爺绌剁敓鍏ュ(xu茅)鑰冭│姝峰勾鑰冪爺鐪熼銆佽€冨崥鐪熼銆佺瓟妗堬紝閮ㄥ垎瀛�(xu茅)鏍℃洿鏂拌嚦2012骞�锛�2013骞�锛涘潎鎻愪緵鏀惰不(f猫i)涓嬭級銆� 涓嬭級娴佺▼锛� 鑰冪爺鐪熼 榛�(di菐n)鎿娾€�鑰冪爺瑭﹀嵎鈥濃€濅笅杓�; 鑰冨崥鐪熼 榛�(di菐n)鎿娾€�鑰冨崥瑭﹀嵎搴�鈥� 涓嬭級
纰╁＋鐮旂┒鐢熸嫑鐢熻€冭│鍒濊│绉戠洰鑰冭│澶х侗
绉戠洰鍚嶇ū锛氳静(n贸ng)妤�(y猫)鐭ヨ瓨缍滃悎涓夛紙椋熷搧鍔犲伐鑸囧畨鍏級
涓€銆佽€冭│鐨勮寖鍦嶅強鐩(bi膩o)
鑰冭│鍏�(n猫i)瀹规兜钃嬮鍝佽(w猫i)鐢熷(xu茅)銆侀鍝佸畨鍏ㄧ鐞嗚垏娉曡(gu墨)銆侀鍝佸垎鏋愯垏妾㈤鎶€琛�(sh霉)绛夐
鍝佸姞宸ヨ垏瀹夊叏闋�(l菒ng)鍩熺殑涓诲共瑾茬▼銆�
瑕佹眰鑰冪敓姣旇純绯荤当(t菕ng)鍦颁簡瑙ｆ湁闂�(gu膩n)鐨勫熀鏈蹇�銆佸師鐞�锛屾帉鎻″熀鏈殑椋熷搧琛�(w猫i)鐢熷(xu茅)鐨�
瑭曞児鏂规硶浠ュ強闋�(y霉)闃叉帶鍒舵帾鏂姐€備簡瑙ｈ唱(zh矛)閲忕鐞嗛珨绯昏垏鎺у埗妯�(bi膩o)婧�(zh菙n)銆傛帉鎻￠鍝佷紒妤�(y猫)鑹ソ
鎿嶄綔瑕�(gu墨)鑼�(GMP)鐨勮姹�锛涢鍝佹坊鍔犲姂浣跨敤琛�(w猫i)鐢熸(bi膩o)婧�(zh菙n)涓昏瑕佹眰锛涢鍝佷腑鏈夋瘨鏈夊鐗�
璩�(zh矛)鏈€楂樻畼鐣欓檺閲忔(bi膩o)婧�(zh菙n)鐨勫収(n猫i)瀹广€傛帉鎻￠鍝佺嚐椁�(y菐ng)鎴愬垎鍒嗘瀽锛岄鍝佷腑姹℃煋鐗╄唱(zh矛)鐨勫垎鏋愶紝
椋熷搧娣诲姞鍔戠殑鍒嗘瀽绛夈€傝兘澶犻亱(y霉n)鐢ㄥ熀鏈師鐞嗗拰鏂规硶鍒嗘瀽銆佸垽鏂峰拰瑙ｆ焙鏈夐棞(gu膩n)瀵�(sh铆)闅涘晱椤�銆�
浜�銆佽€冭│褰㈠紡鑸囪│鍗风祼(ji茅)妲�(g貌u)
1锛庣瓟鍗锋柟寮忥細闁夊嵎锛岀瓎瑭�銆�
2锛庤│鍗峰垎?j菒n)?sh霉)锛氭豢鍒嗙偤 150 鍒嗭紝鍏朵腑椋熷搧琛�(w猫i)鐢熷(xu茅) 50 鍒�銆侀鍝佸畨鍏ㄧ鐞嗚垏娉曡(gu墨)
50 鍒�銆侀鍝佸垎鏋愯垏妾㈤ 50 鍒�銆�
3锛庤│鍗风祼(ji茅)妲�(g貌u)鍙婇鍨嬫瘮渚嬶細
瑭﹀嵎涓昏鍒嗙偤涓夊ぇ閮ㄥ垎锛屽嵆锛氬熀鏈蹇甸绱� 40%锛涘熀鏈悊璜栧垎鏋愰绱� 30%锛�
鐭ヨ瓨缍滃悎閬�(y霉n)鐢ㄩ绱� 30%銆�
涓�銆佽€冭│鍏�(n猫i)瀹硅榛�(di菐n)
锛堜竴锛夐鍝佽(w猫i)鐢熷(xu茅)
1. 绶掕珫
椋熷搧瀹夊叏琛�(w猫i)鐢熷(xu茅)锛涢鍝佸畨鍏ㄧ殑姝峰彶銆佺従(xi脿n)鐙€銆侀鍝佸畨鍏ㄨ(w猫i)鐢熷(xu茅)鐨勪富瑕佷换鍕�(w霉)銆�
2. 鐢熺墿鎬ф薄鏌撹垏椋熷搧瀹夊叏
椋熷搧涓殑鐢熺墿姹℃煋鐗╃殑绋锛岀窗(x矛)鑿屾薄鏌撹垏绱�(x矛)鑿屾瘨绱�銆侀湁鑿屾薄鏌撹垏闇夎弻姣掔礌銆�
甯歌鐨勪汉鐣滃叡鎮ｇ梾灏嶉鍝佸畨鍏ㄧ殑褰遍熆鍙婇爯(y霉)闃插皪绛�銆�
3. 鐠�(hu谩n)澧冩薄鏌撶墿鑸囬鍝佸畨鍏�
鐠�(hu谩n)澧冩薄鏌撹垏椋熷搧瀹夊叏鐨勯棞(gu膩n)绯伙紙鐠�(hu谩n)澧冩薄鏌撶墿銆佺┖姘ｆ薄鏌�銆佹按楂旀薄鏌撱€佸湡澹ゆ薄鏌�
绛夛級锛涚挵(hu谩n)澧冩薄鏌撶墿姹℃煋椋熷搧鐨勯€斿緫鍙婇爯(y霉)闃插皪绛�銆�
4. 鍖栧(xu茅)姹℃煋鑸囬鍝佸畨鍏ㄦ€�
椋熷搧涓殑鍖栧(xu茅)姹℃煋鐗╃殑绋锛岃静(n贸ng)钘ユ畼鐣�銆佺嵏钘ユ畼鐣�銆侀鍝佹坊鍔犲姂灏嶉鍝佸畨鍏�
鐨勫奖闊垮強闋�(y霉)闃插皪绛�銆�
5. 椋熷搧涓殑澶╃劧鏈夋瘨鐗╄唱(zh矛)
椋熷搧涓殑澶╃劧鏈夋瘨鐗╄唱(zh矛)绋锛屽父瑕嬬殑椋熷搧澶╃劧鏈夋瘨鐗╄唱(zh矛)鍙婇爯(y霉)闃插皪绛�銆�
6. 椋熷搧鍔犲伐閬庣▼涓殑瀹夊叏鑸囪(w猫i)鐢�
椋熷搧鍔犲伐閬庣▼涓殑瀹夊叏鑸囪(w猫i)鐢熷晱椤�锛屽嫊妞嶇墿椋熷搧鐨勫畨鍏ㄨ垏琛�(w猫i)鐢熷晱椤�銆�
7. 椋熷搧瀹夊叏鎬ц⿻鍍�
椋熷搧瀹夊叏鎬ц⿻鍍圭殑鍘熺悊銆佹柟娉�锛岄鍝佸畨鍏ㄦ€ц⿻鍍圭殑绋嬪簭銆�
8. 椋熷搧瀹夊叏绠＄悊
椋熷搧瀹夊叏绠＄悊鐨勬湁闂�(gu膩n)娉曞緥銆佹硶瑕�(gu墨)锛岄鍝佸畨鍏ㄧ鐞嗙殑鍘熺悊銆佹柟娉曪紝椋熷搧瀹夊叏绠�
鐞嗗強鎺у埗楂旂郴銆�
锛堜簩锛夐鍝佸畨鍏ㄧ鐞嗚垏娉曡(gu墨)
1. 椋熷搧妯�(bi膩o)婧�(zh菙n)鑸囨硶瑕�(gu墨)鐨勫熀绀�(ch菙)鐭ヨ瓨
娉曞緥娉曡(gu墨)鐨勫熀鏈蹇�锛屾垜鍦嬬殑绔嬫硶閬庣▼鍜岄鍝佹硶寰嬫硶瑕�(gu墨)鐨勯珨绯诲拰娣垫簮銆傞鍝�
娉曞緥娉曡(gu墨)鐨勬蹇点€侀仼鐢ㄨ寖鍦�銆侀鍝佽鏀垮煼(zh铆)娉曡垏鐩�(ji膩n)鐫ｃ€�
2. 涓湅鐨勯鍝佹硶寰嬫硶瑕�(gu墨)
鎴戝湅椋熷搧娉曞緥娉曡(gu墨)鐨勪富瑕佸収(n猫i)瀹瑰強鍏剁祼(ji茅)妲�(g貌u)锛屻€婁腑鑿汉姘戝叡鍜屽湅椋熷搧瀹夊叏娉曘€嬬殑涓�
瑕佸収(n猫i)瀹�銆傛硶寰嬫硶瑕�(gu墨)灏嶉鍝佺敓鐢�(ch菐n)鐨勮姹傘€�
3. 鍦嬮殯鍜岀櫦(f膩)閬�(d谩)鍦嬪椋熷搧妯�(bi膩o)婧�(zh菙n)鑸囨硶瑕�(gu墨)
鍦嬮殯椋熷搧娉曞緥娉曡(gu墨)鐨勫熀鏈娉�锛屽叾瀵�(sh铆)璩�(zh矛)鎬ц姹�锛涙湁闂�(gu膩n)鐧�(f膩)閬�(d谩)鍦嬪椋熷搧妯�(bi膩o)婧�(zh菙n)鍜屾硶
寰嬫硶瑕�(gu墨)楂旂郴锛學TO/TBT 鍗�(xi茅)瀹氬拰 WTO/SPS 鍗�(xi茅)璀颁富瑕佸収(n猫i)瀹�銆傞噰鐢ㄥ湅闅涙(bi膩o)婧�(zh菙n)鐨勫師鍓囧拰
鏂规硶锛�
4. 椋熷搧妯�(bi膩o)婧�(zh菙n)鐭ヨ瓨
妯�(bi膩o)婧�(zh菙n)鐨勫垎椤炲拰妯�(bi膩o)婧�(zh菙n)楂旂郴锛涙(bi膩o)婧�(zh菙n)鍜屾(bi膩o)婧�(zh菙n)鍖栫殑鍩烘湰姒傚康鍜屽熀鏈壒寰�锛涙(bi膩o)婧�(zh菙n)鐨勭祼(ji茅)妲�(g貌u)銆�
鍒跺畾妯�(bi膩o)婧�(zh菙n)鐨勫熀鏈師鍓囧拰涓€鑸▼搴忋€�
5. 鎴戝湅鐨勯鍝佹(bi膩o)婧�(zh菙n)
椋熷搧鍩虹(ch菙)妯�(bi膩o)婧�(zh菙n)锛涚啛鎮夌稜鑹查鍝佹(bi膩o)婧�(zh菙n)銆佹湁姗�(j墨)椋熷搧妯�(bi膩o)婧�(zh菙n)銆佺劇鍏椋熷搧銆佷繚鍋ラ鍝�
妯�(bi膩o)婧�(zh菙n)銆佽蓟鐓ч鍝佹(bi膩o)婧�(zh菙n)鐨勭浉闂�(gu膩n)鍏�(n猫i)瀹�銆傞鍝佹椹楁柟娉曟(bi膩o)婧�(zh菙n)銆侀鍝佹坊鍔犲姂妯�(bi膩o)婧�(zh菙n)銆侀鍝佹祦
閫氭(bi膩o)婧�(zh菙n)銆�
6. 椋熷搧璩�(zh矛)閲忕鐞嗛珨绯�
椋熷搧鑹ソ鐢熺敘(ch菐n)瑕�(gu墨)鑼冿紙GMP锛夌殑鍏�(n猫i)瀹�锛屽(sh铆)鏂� GMP 鐨勬剰缇╋紝琛�(w猫i)鐢熸(bi膩o)婧�(zh菙n)鎿嶄綔绋嬪簭鐨�
鍏�(n猫i)瀹�锛孒ACCP 楂旂郴鐨勪竷澶у師鐞嗗強椋熷搧鐢熺敘(ch菐n)涓殑鎳�(y墨ng)鐢ㄥ(sh铆)渚�銆�
锛堜笁锛夐鍝佸垎鏋愯垏妾㈤
1. 椋熷搧鍒嗘瀽鐨勫熀鏈煡璀�
椋熷搧鍒嗘瀽閲囬泦妯ｅ搧鐨勬剰缇╋紝瑭︽ǎ姝ｇ⒑閲囧彇銆佸埗鍌欏強闋�(y霉)铏曠悊绛夌殑鏂规硶銆�
2. 椋熷搧鍒嗘瀽鐨勪竴鑸柟娉�
椋熷搧鍒嗘瀽涓墿鐞嗗垎鏋愮殑鍩烘湰鏂规硶鈥旀瘮閲嶆硶銆佹姌鍏夋硶鑸囨棆鍏夋硶銆傚垎鏋愬師鐞嗗強鍎€
鍣ㄧ殑涓昏閮ㄤ欢妲�(g貌u)閫�銆�
3. 椋熷搧涓竴鑸垚鍒嗙殑妾㈤
椋熷搧涓竴鑸嚐椁�(y菐ng)鎴愬垎锛堟按鍒�銆佺伆鍒�銆侀吀搴︺€佽剛椤�銆佺⒊姘村寲鍚堢墿銆佽泲鐧借唱(zh矛)銆佺董
鐢熺礌绛夛級鐨勬脯瀹氬師鐞嗗強鏂规硶銆�
4. 椋熷搧娣诲姞鍔戠殑妾㈤
椋熷搧涓富瑕佹坊鍔犲姂鐨勬脯瀹氬師鐞嗗強鏂规硶銆�
5. 閲嶉噾灞殑妾㈤
涓昏鐨勯噸閲戝爆灏嶄汉楂旂殑鍗卞鍙婇檺閲忥紝骞剧ó閲嶉噾灞厓绱犲父鐢ㄧ殑娓畾鏂规硶鍙婂師鐞�銆�
6. 椋熷搧涓静(n贸ng)钘ユ畼鐣欓噺鐨勬椹�
鏈夋(j墨)姘静(n贸ng)钘ユ畼鐣欓噺鍙婇粌鏇查湁姣掔礌鐨勬娓師鐞嗗強鏂规硶銆�
鍏嶈铂(z茅)鑱叉槑锛氭湰鏂囩郴杞�(zhu菐n)杓夎嚜缍�(w菐ng)绲�(lu貌)锛屽鏈変镜鐘�锛岃珛鑱�(li谩n)绯绘垜鍊戠珛鍗冲埅闄�锛屽彟锛氭湰鏂囧儏浠ｈ〃浣滆€呭€嬩汉瑙€榛�(di菐n)锛岃垏鏈恫(w菐ng)绔欑劇闂�(gu膩n)銆傚叾鍘熷壍(chu脿ng)鎬т互鍙婃枃涓櫝杩版枃瀛楀拰鍏�(n猫i)瀹规湭缍�(j墨ng)鏈珯璀夊(sh铆)锛屽皪鏈枃浠ュ強鍏朵腑鍏ㄩ儴鎴栬€呴儴鍒嗗収(n猫i)瀹�銆佹枃瀛楃殑鐪熷(sh铆)鎬�銆佸畬鏁存€с€佸強鏅傛€ф湰绔欎笉浣滀换浣曚繚璀夋垨鎵胯锛岃珛璁€鑰呭儏浣滃弮鑰�锛屽苟璜嬭嚜琛屾牳瀵�(sh铆)鐩搁棞(gu膩n)鍏�(n猫i)瀹�銆�
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鏂囩珷鎼滅储
鎮ㄧ従(xi脿n)鍦ㄧ殑浣嶇疆锛� 
