銆婅綆楁満鍖栫郴緇熴嬭鍥戒駭浠櫒闈復涓ュ郴鎸戞垬
2016-1-27 鏉ユ簮:涓浗鑱氬悎鐗╃綉 鐐瑰嚮嬈?/span>
鍏抽敭璇嶏細璁＄畻鏈哄寲緋葷粺 鍥戒駭浠櫒 GMP
2015騫?鏈?6鏃ワ紝CFDA鏇懼彂甯冣溿婅嵂鍝佺敓浜ц川閲忕鐞嗚鑼?2010騫翠慨璁?銆嬭綆楁満鍖栫郴緇熷拰紜涓庨獙璇佷袱涓檮褰曠殑鍏憡(2015騫寸54鍙?鈥?鍏朵袱涓檮褰曞垎鍒負鈥滆綆楁満鍖栫郴緇熲濆拰鈥滅‘璁や笌楠岃瘉鈥濄傚叕鍛婅嚜2015騫?2鏈?鏃ヨ搗瀹炴柦銆?/span>
綆鍗曟潵璇達紝娉曡瑕佹眰鍒惰嵂浼佷笟鎵鏈夌敤浜庢斁琛屼駭鍝併佷駭鐢熸暟鎹殑浠櫒錛岄兘蹇呴』鍏峰鈥滃璁¤拷韙濆姛鑳斤紝浠ヤ繚璇佹暟鎹畬鏁存?蹇呴』瀵圭郴緇熻闂強鎿嶄綔榪涜璁板綍錛屼互鏄劇ず鈥滀綍鏃剁敱璋佸洜浣曞師鍥犲仛鍑轟簡浠涔堝姩浣溾濄?/span>
鏂伴甯冪殑銆婅綆楁満鍖栫郴緇熴嬫硶瑙勯檮褰曟槸鍥藉唴娉曡涓庡浗闄呮帴杞ㄧ殑閲嶈涓姝ワ紝灝嗗～琛ュ浗鍐呭浜庤綆楁満鍖栫郴緇熻姹傜殑娉曡絀虹櫧錛屾槸瀹炵幇涓庡浗闄呮硶瑙勭洃綆℃満鏋勪箣闂寸浉浜掕鍙殑鍓嶆彁鏉′歡涔嬩竴銆?/span>
浠庡埗鑽紒涓氳嚜韜潵璇達紝鍘嗙粡2015騫村叏騫碈FDA棰戠箒鐨勯琛屾鏌ワ紝涓嶆柇鏈変紒涓欸MP璇佷功琚彇娑堬紝鍥藉唴GMP鐨勭洃綆″姏搴︽樉钁楁彁楂橈紝鏃犺浠庝繚璇佷駭鍝佽川閲忥紝榪樻槸浠庡簲瀵規鏌ョ殑瑙掑害鏉ヨ錛屼紒涓氶兘蹇呴』絎﹀悎銆婅綆楁満鍖栫郴緇熴嬫硶瑙勭殑瑕佹眰銆?/span>
娉曡榪樻彁鍑哄鐢靛瓙鏁版嵁瀹夊叏鎬х殑瑕佹眰銆傜數瀛愭暟鎹畨鍏ㄦт竴鑸垎涓洪昏緫瀹夊叏鎬у拰鐗╃悊瀹夊叏鎬с傞昏緫瀹夊叏鎬у嵆鏄氳繃杞歡鑷韓鐨勬潈闄愭帶鍒跺鏁版嵁鐨勮闂佸綍鍏ャ佷慨鏀瑰拰鍒犻櫎絳夋搷浣滐紝紜繚涓嶈浜轟負璇搷浣滄垨鏈夋剰鐨勭鏀硅涓鴻屽獎鍝嶆暟鎹畨鍏ㄣ傝岀墿鐞嗗畨鍏ㄦэ紝鍗蟲槸瀵規暟鎹瓨鍌ㄧ殑浠嬭川(濡傜‖鐩樸佸厜鐩樸佹湇鍔″櫒絳?榪涜淇濇姢錛岀‘淇濈郴緇熸湰韜笉浼氬洜涓虹墿鐞嗕粙璐ㄧ殑鎹熷潖鎴栨晠闅滈犳垚鏁版嵁涓㈠け銆?/span>
鍙﹀錛岃繕鍗曠嫭鍒楀嚭浜嗏滄暟鎹浠借姹傗濓紝榪欏皢鎻愰珮鍒惰嵂浼佷笟瀵規暟鎹浠界殑閲嶈錛屼笉璁烘槸浠ョ數瀛愭暟鎹綔涓轟富鏁版嵁錛岃繕鏄焊璐ㄦ墦鍗頒歡浣滀負涓繪暟鎹?/span>
閫氳繃鈥滃璁¤拷韙濆姛鑳斤紝鍙拷韙鏁版嵁鐨勮闂殑鏇存敼錛屾槸緇存姢緋葷粺瀹夊叏鐨勫叧閿?/span>
銆婅綆楁満鍖栫郴緇熴嬮檮褰曟槑紜鍙數瀛愭暟鎹拰鐢靛瓙絳懼悕錛岃繖鎰忓懗鐫鍘熷鏁版嵁鍙互涓嶇敤鍍忎互寰閭ｆ牱鎵撳嵃鍑烘潵鍐嶇鍚嶏紝鐩存帴瀵圭數瀛愭暟鎹繘琛岀鍚嶆槸鍚堣鐨勩傚湪涓嶄箙鐨勫皢鏉ワ紝鍒惰嵂浼佷笟鎴栧皢鐢變紶緇熺殑綰焊璐ㄨ褰曢愭笎杞悜鏇翠負鐏墊椿鐨勭數瀛愭暟鎹拰淇℃伅鐜銆?/span>
鏍規嵁銆婅綆楁満鍖栫郴緇熴嬮檮褰曠殑瑕佹眰錛岄櫎浜嗚壊璋辯被(LC鍜孏C)鏁版嵁錛屽疄楠屽涔熻紜繚闈炶壊璋辯被鏁版嵁鐨勫畨鍏ㄦу拰鍚堣鎬э紝姣斿璐ㄨ氨銆佺孩澶栥佹牳紓佺瓑浠櫒錛岃嚦灝戣淇濊瘉璇曢獙鏃墮棿鏃犳硶淇敼銆?/span>
濡備粖錛岃窛鍏憡寮濮嬪疄鏂藉凡榪戜袱涓湀錛岃櫧鐒跺洜緇忔祹鍘熷洜閮ㄥ垎浼佷笟鍙互寤舵湡鏂借錛屼絾榪欏凡緇忔槸澶у娍鎵瓚嬶紝鏈潵鎵鏈変紒涓氶兘蹇呴』絎﹀悎鏂扮増GMP瑕佹眰鎵嶅彲榪涜鐢熶駭銆傜洰鍓嶈繘鍙ｄ華鍣ㄧ殑鐩稿叧璁＄畻鏈哄寲緋葷粺鍔熻兘閮芥瘮杈冨畬澶囷紝浣嗕環鏍間笉鑿層備婦渚嬫潵璇達紝鍗佷竾鍒嗕箣涓鐨勫垎鏋愬ぉ騫籌紝鍏跺井鐢佃剳鎺у埗闈㈡澘鍙‘淇濇搷浣滆兘澶熻璁板綍錛屼絾浠鋒牸鍧囧湪鍗佷竾鍏冧漢姘戝竵浠ヤ笂錛屽浜庤嵂鍘傛潵璇達紝涓鍙板垎鏋愬ぉ騫蟲樉鐒朵笉鍙兘婊¤凍鏃ュ父鐢熶駭媯楠岀殑闇姹傦紝鍙兂鑰岀煡錛岀鍚堟柊娉曡鐨勮嵂鐗╁垎鏋愪華鍣ㄥ鏋滈兘閲囩敤榪涘彛浠櫒錛岃姳璐瑰繀鐒跺彲瑙?鍥戒駭浠櫒铏界劧鐗╃編浠峰粔錛屼絾鏄湪璁＄畻鏈哄寲緋葷粺涓婏紝鍗翠粛涓虹煭鏉匡紝涓虹鍚圙MP璁＄畻鏈哄寲緋葷粺瑕佹眰錛屽浗浜т華鍣ㄥ巶鍟嗗皢闈復涓ュ郴鎸戞垬銆?/span>
鍏嶈矗澹版槑錛氶儴鍒嗚祫鏂欐潵婧愪簬緗戠粶錛岃漿杞界殑鐩殑鍦ㄤ簬浼犻掓洿澶氫俊鎭強鍒嗕韓錛屽茍涓嶆剰鍛崇潃璧炲悓鍏惰鐐規垨璇佸疄鍏剁湡瀹炴э紝
涔熶笉鏋勬垚鍏朵粬寤鴻銆備粎鎻愪緵浜ゆ祦騫沖彴錛屼笉涓哄叾鐗堟潈璐熻矗銆傚娑夊強渚墊潈錛岃鑱旂郴鎴戜滑鍙婃椂淇敼鎴栧垹闄ゃ?br>閭錛歩nfo@polymer.cn
錛堣矗浠葷紪杈戯細xu錛?
