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CMA&CNAS鍙婂痉鍥紻akks&缇庡浗A2LA锛圛SO17025锛夊疄楠屽璁よ瘉璁ゅ彲鐢宠鐮斾慨鐝紙绾夸笂缃戠粶鐩存挱锛堻/a>鍩硅鏃堕棿锛 2023-11-23 鑷 2023-11-24缁撴潫 鍩硅鍦扮偣锛涓浗绾夸笂缃戠粶鐩存挱锛堣鎯呭挩璇㈠鏈嶏級 |
 寰俊鎵竴鎵?/p> 浼氬煿鍔ㄦ€侀兘鐭ユ檽 |
鍚勬湁鍏冲崟浣嶏細
闅忕潃鍥藉唴鍒惰嵂琛屼笟瀵圭爺鍙?amp;QC瀹為獙瀹わ紙鎴栫О锛氭娴嬩腑蹇?鍒嗘瀽瀹為獙瀹わ級鐨勫叧娉ㄥ拰鎶曞叆鎸佺画澧炲姞锛屽疄楠屽纭欢鏈変簡璐ㄩ璺冦€備絾QC瀹為獙瀹ょ殑绠＄悊鍜岃繍钀ユ按骞宠繕鏄瘮杈冩瑺缂恒€傜敱浜庡疄楠屽绠＄悊缂轰箯绯荤粺鎬х殑鎬濊€冨拰绛栧垝锛屽疄楠屽鐨勮蒋瀹炲姏鎴愪负瑙勮寖鍖栧拰鍥介檯鍖栫鐞嗙殑杞倠锛屽紑濮嬪紩璧蜂笟鐣岀殑鍏虫敞锛涘緢澶氬埗鑽ご閮ㄤ紒涓氱殑QC瀹為獙瀹わ紙涔熷寘鍚爺鍙戝疄楠屽锛夛紝宸插紑濮嬪紩杩汭SO 17025 瀹為獙瀹ょ鐞嗕綋绯伙紝骞舵寜鐓SO17025浣撶郴杩涜杩愯惀鍜岀鐞嗭紝鑾峰緱CNAS璁ゅ彲銆傛埅姝㈢洰鍓嶏紝鑾峰緱CNAS17025 璁ゅ彲鐨勫疄楠屽鏈?涓囧瀹讹紝鑾峰緱CMA锛堟楠屾娴嬫満鏋勮祫璐ㄨ瀹氾級鏈?涓囧瀹躲€備富瑕佸寘鎷細浜嬩笟鍗曚綅&鐮旂┒闄€€佷紒涓氱殑QC瀹為獙瀹?amp;鐮斿彂鏈烘瀯锛岀涓夋柟鐙珛CRO鏈烘瀯閫氳繃寮曞叆ISO 17025瀹為獙瀹ょ鐞嗕綋绯伙紝鎻愬崌鍒惰嵂浼佷笟QC瀹為獙瀹ょ殑杩愯惀鍜岀鐞嗘按骞筹紝宸叉垚涓哄埗鑽涓氬叡璇嗭紝涔熸垚涓篞C瀹為獙瀹ゅ彂灞曠殑瓒嬪娍銆侟/p>
鐢宠瀹為獙瀹よ璇佽鍙細
鍥藉唴鐢宠锛欳NAS锛堜腑鍥藉浗瀹惰鍙鍛樹細锛夛紝CMA锛堟楠屾娴嬫満鏋勮祫璐ㄨ瀹氾級
鍥藉鐢宠锛欴akks(寰峰浗璁ゅ彲濮?銆乁KAS锛堣嫳鍥界殗瀹惰鍙锛夈€丄2LA锛堢編鍥借鍙崗浼氾級锛汓/p>
濡備綍閫氳繃ISO17025绠＄悊浣撶郴鐨勭郴缁熸€ф€濈淮锛岄闄╃鐞嗙瓑鍚勭璐ㄩ噺绠＄悊鐞嗗康鍜岀鐞嗗伐鍏凤紝浼樺寲娴佺▼锛岀瓥鍒掑拰瀹炴柦璐ㄩ噺鎺у埗锛屾彁鍗囧疄楠屽绠＄悊姘村钩銆傜壒涓惧姙銆奀MA & CNAS鍙婂痉鍥紻akks &缇庡浗A2LA锛圛SO17025锛夊疄楠屽璁よ瘉璁ゅ彲鐢宠鐮斾慨鐝€ 锛岃绋嬩粠缇庡浗銆佸痉鍥姐€佷腑鍥絀SO17025瀹為獙瀹ょ鐞嗕綋绯荤殑绯荤粺鎬ф€濈淮鍑哄彂銆侀槓杩癚C瀹為獙瀹ょ殑璐ㄩ噺绛栧垝銆佽川閲忔帶鍒躲€佸強鏃ュ父鐨勭洃鐫ｇ鐞嗭紝鍖呮嫭鍐呭鍜岀鐞嗚瘎瀹★紝鍚屾椂鍒嗕韩ISO 17025鐨勮繍钀ョ鐞嗘渚嬶紝鎻愬崌瀹為獙瀹ょ殑绠＄悊姘村钩锛岀幇璇氶個鍚勫崟浣嶇殑骞挎硾鍙備笌銆侟/p>
璇剧▼璁捐
1銆丆MA & CNAS 璁ゅ彲瀹為獙瀹ゅ唴瀹″憳锛氬唴瀹＄瓥鍒掞紝瀹炴柦鎶€宸э紝鏍规湰鍘熷洜鍒嗘瀽鍙婂叧闂紱
2銆佸浗鍐呭锛欼SO 17025瀹為獙瀹よ川閲忕鐞嗕綋绯荤殑绛栧垝銆佽繍钀ュ拰绠＄悊锛汓/p>
3銆両SO 17025 澶氫綋绯绘湁鏈鸿瀺鍚堬紙CNAS銆丆MA銆丏akks銆乁KAS銆丄2LA锛夈€侟/p>
绗?/strong>1鑺傦細QC瀹為獙瀹ゃ€佺爺鍙戝疄楠屽銆丆RO鏈烘瀯闈复鐨勶細鎸戞垬涓庢満閬囷紱
绗?/strong>2鑺傦細QC瀹為獙瀹ょ殑鍩虹煶锛汓/strong>
2.1銆奊MP-Lab 璐ㄩ噺鎺у埗瀹為獙瀹ょ鐞嗐€嬫潯娆炬⒊鐞嗭紱
2.2銆奊MP-Lab 璐ㄩ噺鎺у埗瀹為獙瀹ょ鐞嗐€嬬殑澶╃劧缂洪櫡锛汓/p>
2.3銆奊MP-Lab 璐ㄩ噺鎺у埗瀹為獙瀹ょ鐞嗐€嬩笌銆奍SO 17025銆嬪紓鍚岀偣瑙ｆ瀽锛汓/p>
绗?/strong>3鑺傦細鑽搧璐ㄩ噺浣撶郴妯″瀷
3.1 ICH Q10鑽搧璐ㄩ噺浣撶郴妯″瀷锛圥QS锛堻/p>
3.2 ICH Q10 璐ㄩ噺鏂归拡 & 璐ㄩ噺鐩爣
3.3 ICH Q10 鐭ヨ瘑绠＄悊妯″瀷
3.4 ICH Q10鍩轰簬椋庨櫓鐨勬€濈淮 Risk Base Thinking
绗?/strong>4鑺傦細CMA & CNAS 娉曡鍙婄敵璇锋祦绋婞/strong>
4.1 CMA娉曡銆婂競鍦虹洃鐫ｇ鐞嗘€诲眬锛?63鍙蜂护+39鍙蜂护銆婞/p>
4.2 CMA锛堟楠屾娴嬫満鏋勮祫璐ㄨ瀹氾級鐢宠娴佺▼鍙婃渚嬪垎浜紱
鐢宠CMA鐨勫墠鎻愭潯浠讹紱
鐢宠CMA鐨勪綋绯荤殑鎼缓锛汓/p>
4.3 鐢宠CNAS 17025璁ゅ彲鐨勬祦绋嬪強妗堜緥鍒嗕韩锛汓/p>
锛?锛夊埗鑽涓氬ご閮ㄤ紒涓氱敵璇稢NAS 瀹為獙瀹よ秼鍔匡紱
锛?锛夌敵璇稢NAS 17025璁ゅ彲鐨勫墠鎻愶紱
锛?锛夌敵璇稢NAS 17025璁ゅ彲鐨勫噯澶囧伐浣滐紱
锛?锛夋彁浜NAS 17025璁ゅ彲鐨勭敵璇锋潗鏂欙紱
锛?锛塁NAS 17025璁ゅ彲鐨勭幇鍦鸿瘎瀹℃渚嬪垎浜?/p>
4.4 CMA鍜 CNAS鐨勮仈鍚堣瘎瀹★紱
绗?/strong>5鑺傦細娆х編ISO17025鐢宠娴佺▼
5.1 ISO17025鐢宠锛欴akks(寰峰浗璁ゅ彲濮?銆乁KAS锛堣嫳鍥界殗瀹惰鍙锛夈€丄2LA锛堢編鍥借鍙崗浼氾級锛汓/p>
5.2 涓浗CNAS涓庢缇嶪SO17025鐜板満璇勫锛氬樊璺濆垎浜紱
5.3 杩庢帴CNAS鍜孌AKKS銆丄2LA鍥藉唴澶栫幇鍦鸿瘎瀹★細鍑嗗鍜屾妧宸э紱
绗?/strong>6鑺傦細CMA銆丆NAS銆丏akks銆丄2LA绛夊浣撶郴铻嶅悎
6.1 鎵嬫妸鎵嬫暀浣狅細澶氫綋绯昏瀺鍚堟€濊矾鍜岃惤鍦帮紝锛汓/p>
6.2 璐ㄩ噺鎵嬪唽鐨勮瀺鍚堬紱
6.3 绋嬪簭鏂囦欢鐨勮瀺鍚堬紱
6.4 浣滀笟鎸囧涔︾殑铻嶅悎锛汓/p>
绗?/strong>7鑺傦細瀹為獙瀹ゅ浣曠‘淇濓細鍏鎬 & 淇濆瘑鎬?/strong>
绗?/strong>8鑺傦細瀹為獙瀹ゆ竻鏅扮殑缁勭粐鏋舵瀯锛汓/strong>
绗?/strong>9鑺傦細浜哄憳鐨勯棴鐜鐞嗭細鍩硅銆佷笂宀椼€佺洃鐫ｏ紱
绗?/strong>10鑺傦細璁炬柦鍜岀幆澧冩潯浠跺妫€娴嬬粨鏋滅殑褰卞搷锛汓/strong>
绗?/strong>11鑺傦細浠櫒璁惧妫€瀹氭牎鍑嗕笌璁￠噺婧簮鎬х殑寤虹珛锛汓/strong>
绗?/strong>12鑺傦細渚涘簲鍟嗗璁″強骞村害璇勪及锛汓/strong>
绗?/strong>13鑺傦細鍚堝悓璇勫涓庡悎瑙勭鐞嗚姹傦紱
绗?/strong>14鑺傦細鏂规硶楠岃瘉& 鏂规硶纭 Method validation & Method verification;
绗?/strong>15鑺傦細鏍峰搧鐢熷懡鍛ㄦ湡绠＄悊;
绗?/strong>16鑺傦細娴嬮噺涓嶇‘瀹氬害鍦ㄥ尰鑽鍩熺殑搴旂敤锛汓/strong>
绗?/strong>17鑺傦細濡備綍绛栧垝鍐呴儴鍜屽閮ㄨ川閲忔帶鍒讹紝纭繚缁撴灉鍑嗙‘鎬э紱
锛?锛夎川閲忔帶鍒剁殑绛栧垝涓庡疄鏂斤紱
锛?锛塈SO17025鐨勮川閲忔帶鍒舵ā鍨婞/p>
绗?/strong>18鑺傦細妫€娴嬫姤鍛婂鏍稿拰淇敼娴佺▼锛屽強瀹氭湡鎶芥煡
绗?/strong>19鑺傦細濡備綍浠庨浂寮€濮嬶紝鎼缓璐ㄩ噺绠＄悊浣撶郴&Mind map 鎬濈淮瀵煎浘锛汓/strong>
绗?/strong>20鑺傦細瀹為獙瀹よ壇濂借褰曡鑼僄DP锛欸ood Document Practice
绗?/strong>21鑺傦細椋庨櫓绠＄悊& 椋庨櫓璇勪及Risk Assessment & FEMA锛汓/strong>
绗?/strong>22鑺傦細绛栧垝澧炲€肩殑鍐呴儴瀹℃牳
锛?锛夊唴瀹＄殑娴佺▼&鎶€宸э細鐜板満璇勫瀹炴搷妗堜緥锛汓/p>
锛?锛夊唴瀹℃姤鍛夵/p>
锛?锛夊唴瀹＄殑璺熻釜涓庡叧闂紱
绗?/strong>23鑺傦細鎺堟潈绛惧瓧浜烘槸鎬庝箞鐐兼垚鐨凕/strong>
涓昏鑰佸笀锛氬紶娉芥シ瀹為獙瀹よ鍙笓瀹讹細Dakks(寰峰浗璁ゅ彲濮?銆乁KAS锛堣嫳鍥界殗瀹惰鍙锛夈€丄2LA锛堢編鍥借鍙崗浼氾級銆丆NAS锛堜腑鍥藉浗瀹惰鍙鍛樹細锛夛紝CMA锛堟楠屾娴嬫満鏋勮祫璐ㄨ瀹氾級锛汓/p>
-杩戜簩鍗佸勾娆х編澶栬祫CRO鏈烘瀯鍙奞C瀹為獙瀹わ細杩愯惀绠＄悊銆佽川閲忕鐞嗙粡楠岋紱
-涓板瘜鐨勫疄鎿嶇粡楠岋細GMP銆丱ECD-GLP銆丟PCL銆両SO17025銆両SO17065銆両SO17020绛夛紱
-涓板瘜鐨凲A & QC缁忛獙锛屽強绗簩鏂瑰拰绗笁鏂瑰璁＄粡楠岋紱
-200浣欐鏀垮簻鍜屽鎴峰璁＄粡鍘嗭細CNAS銆丏akks銆乁KAS銆丆FDA銆丗DA銆丆DE銆 CRO绛夛紱
-绮剧泭瀹為獙瀹ょ鐞嗐€佹祦绋嬩紭鍖栥€侀」鐩鐞嗛【闂紱
鑱旂郴浜猴細楂樿€佸笀
鐢?nbsp; 璇濓細15376602038锛堝井淇″悓鍙凤級
搴?nbsp; 鏈猴細0535-2122191
閭?nbsp; 绠憋細ctc@www.sqrdapp.com
Q Q 锛?416988473
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