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-凯时国际


uvprobe鏄叿鏈夊鍔熻兘锛屾搷浣滀究鎹风殑杞欢锛屼綔涓烘爣鍑嗛厤缃簬宀涙触uv-vis鍒嗗厜鍏夊害璁′腑銆傚綋涓嶤lass-agent杞欢閰嶅悎浣跨敤鏃讹紝鍙己鏈夊姏鏀寔part 11銆?/p>

鐗圭偣

鍏锋湁澶氱鏁版嵁澶勭悊鍜岃绠楀姛鑳界殑娴嬪畾妯″紡

鍔ㄥ姏瀛︽祴瀹?/p>

闄や簡鍏夎氨鍜屽厜搴︽ā寮忓锛岃繕鏈夊姩鍔涘妯″紡銆傜患鍚堟暟鎹鐞嗗姛鑳藉彲鎻愪緵缁欐瘡涓ā寮忋€?/p>


鑷敱鏍煎紡鐨勬姤鍛婂垱寤?/strong>

鑷敱鍒涘缓鎶ュ憡妯″紡

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glp/gmp鏀寔鍔熻兘

瀹¤杩借釜鍔熻兘

鍙彁渚涘箍娉涚殑glp/gmp 鏀寔鍔熻兘锛屽寘鎷畨鍏ㄦ€ц兘锛岃濡傜敤鎴锋巿鏉冧互鍙婃巿鏉冭缃紝瀵瑰師鏁版嵁鐨勫璁¤拷韪姛鑳姐€佹暟鎹鐞嗗巻鍙插拰浠櫒鐧诲叆銆?/p>

鍙笌閫夐厤class-agent杞欢鑱旂敤锛屾敮鎸丗da 21 cfr part 11鐨勮瀹氥€傚悓鏃朵娇鐢║vprobe閲囬泦鏁版嵁锛岃绠楀緱鍒扮殑鏁版嵁鍙互鑷姩鎴栨墜鍔ㄧ殑鏂瑰紡淇濆瓨鑷虫暟鎹簱銆?/p>

· 瀹夊叏鎬у姛鑳?/p>

褰撲娇鐢ㄥ畨鍏ㄦ€у姛鑳芥椂锛岀櫥闄嗛渶瑕佹彁渚涚‘璁ょ爜鍜屽瘑鐮侊紝鏀瑰杽鐨勮缃彲閫傜敤浜庡瘑鐮併€傚垎閰嶇粰涓嶅悓鐢ㄦ埛鐨勫姛鑳藉彈鍒颁笉鍚岀殑闄愬埗銆?/p>

· 瀹¤杩借釜鍔熻兘

鏁版嵁鍌ㄥ瓨鍦ㄧ洰褰曠粨鏋勪腑锛屽師濮嬫暟鎹粡杩囪绠楀拰鍏朵粬鏁版嵁澶勭悊鍚庯紝鏁版嵁灏嗕互鏂版暟鎹殑褰㈠紡鍌ㄥ瓨浜庣浉鍚屾枃浠朵腑锛屽巻鍙茶褰?鐢ㄦ埛锛屾棩鏈燂紝鎿嶄綔绛?涔熶細淇濆瓨鍦ㄦ鏂囦欢涓€?/p>

· 鏁版嵁灞ュ巻鍔熻兘

濡傛灉娴嬮噺鏁版嵁鍙戠敓鏀瑰彉锛屽垯灏嗘洿鏀瑰饱鍘嗚拷鍔犲埌鏁版嵁涓€?br /> 涓轰簡浣跨敤杩欎簺鍔熻兘锛?uvprobe蹇呴』瀹夎鍦ㄥ畨鍏ㄦā寮忔垨glp妯″紡涓嬨€?/p>

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