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1銆佷骇鍝佹秹鍙婄殑宸ョ▼淇℃伅: 妯″叿缁撴瀯鐨勮璁′互鍙婂浜у搧鐨勫奖鍝?浜у搧鐨勬?鑳借姹傚喅瀹氶渶瑕侀噰鐢ㄤ粈涔堢殑鏉愭枡,浠ュ強鍦ㄧ敓浜ц繃绋嬩腑閲囩敤浠?箞鏍风殑宸ヨ壓鏉′欢銆?/p>2銆佸伐绋嬩俊鎭殑浼犺揪: 鎴戝徃鏈変笓涓氱殑宸ョ▼鎶?湳浜哄憳涓撻棬澶勭悊瀹㈡埛鐨勫伐绋嬫妧鏈棶棰?骞堕?杩囦笟鍔¤礋璐d汉浼犺揪缁欏鎴?蹇呰鏃?瀹㈡埛鏂瑰彲鑷虫垜鍙哥敓浜х幇鍦哄弬涓庢煡鏍稿拰璁ㄨ鐩稿叧鐨?鎶?湳闂,闄悓灏辩浉鍏崇殑宸ョ▼鎶?湳闂涓庡鎴疯繘琛岄潰瀵归潰杩涜娌熼?,浠ヤ繚鎸佽繀閫熷鐞嗗強瑙e喅闂銆?nbsp;
3銆佸伐绋嬪彉鏇? 鎵?湁鍦ㄤ骇鍝佹牱鍝佺‘瀹氬悗鎵ц鐢熶骇鍓嶆垨鑰呮墽琛岀敓浜х殑杩囩▼锛屽洜涓轰骇鍝佺殑瑁呴厤浣跨敤绛変骇鐢熺殑宸ョ▼鍙樻洿锛屼細鍙屾柟浠ヤ功闈㈢殑鏂瑰紡杩涜纭锛岀劧鍚庡啀瀵逛骇鍝佽繘琛屾洿鏀瑰拰鍐嶇‘璁わ紝鐒跺悗鎸夋渶鏂扮殑瑕佹眰鎵ц鍚庢湡鐢燂紱鍙樻洿鎵?骇鐢熺殑璐圭敤瑙嗗彉鏇村師鍥犲強閲戦鐢卞鎴蜂笌鎴戝徃鍗忚澶勭悊銆?/p> 瀹㈡埛璁㈣揣锛?/strong>
1銆佺敓浜т俊鎭‘璁わ細 鍏徃鍦ㄦ敹鍒板鎴风殑璁㈣喘鍗曟垨鍏卞悓绛惧畾鐨勮璐у悎鍚岃繘琛岀‘璁ゅ悗锛屼互杞寲涓虹浉鍏崇殑瑕佹眰璧勬枡鎸夊叕鍙哥郴缁熸墽琛岀敓浜у強璺熻釜銆?/p>2銆佺敓浜у懆鏈熺‘璁わ細 鏍规涓嶅悓浜у搧鐨勭敓浜х壒鐐癸紝鍔犲伐鍙婂寘瑁呰姹傜瓑锛屼互鍙婂叕鍙稿綋鍓嶇殑鐢熶骇璁″垝闇?3涓伐浣滄棩/7涓伐浣滄棩/12涓伐浣滄棩/15涓伐浣滄棩/25涓伐浣滄棩涓嶅悓闃舵鍙婁氦璐у懆鏈熺瓑銆?br />3銆佺敓浜ц繘搴﹁窡韪細 鎴戝徃鐨勪細鏈変笓涓氱殑璺熷崟浜哄憳璺熻繘瀹㈡埛鐩稿叧浜у搧鐨勭敓浜ф儏鍐靛強杩涘害鐘跺喌,骞跺皢鐩稿叧鐨勬儏鍐靛弽棣堢粰瀹㈡埛,闄ゆ垜鍙镐笟鍔″強涓氬姟璺熷崟浜哄憳澶?鍏跺畠濡傚搧璐ㄥ伐绋嬬瓑閮ㄩ棬浜哄憳涓嶅弬涓庡鎴疯揣鍝佺敓浜х殑鐩存帴娌熼?涓庤仈缁溿? 鍝佽川鎺у埗锛氭牱鏉跨‘璁?-閲忎骇鎶芥--鎴愬搧妫?獙--鍑鸿揣妫?獙
1銆佸師鏉愭枡涓庡師鏉愭枡鍝佽川鎺у埗锛?鍏徃涓?緥浣跨敤缇庡浗/鏃ユ湰/寰峰浗绛夎繘鍙d紭璐ㄧ姗¤兌鍘熸枡锛屽師鏂欏晢涓?緥瑕佹彁渚汻OHS/FDA绛夋潗鏂欒瘉鏄庤嚦鎴戝徃锛屽悓鏃舵枡鍒版垜鍙告寜MIL-105E缁撳悎鍘熸枡IQC妫?獙瑕佹眰杩涜妫?獙锛岀鍚堣姹傛柟鍙姇鏀句娇鐢ㄣ?2銆佺敓浜ц繃绋嬪強鍑鸿揣鍝佽川鎺у埗锛?br /> 2.1銆?姣忎竴浜у搧鐨勪换浣曠敓浜у伐鑹鸿姹傚繀椤诲舰鎴愪功闈㈠苟缁忚鍙殑“宸ヨ壓浣滀笟鎸囧涔?rdquo;锛圡I锛夌‘淇濆憳宸ユ寜MI瑕佹眰鎵ц鐢熶骇銆?br /> 2.2銆?鐢熶骇杩囩▼涓紝鐢辩敓浜у憳宸ュ浜у搧鎸夌‘璁ゆ牱鍝佹爣鍑嗗澶栬鍙婃暣浣撹姹傛墽琛?00%鍏ㄦ锛屽悓鏃剁敱IPQC鎸?宸℃瑕佹眰瀵逛笉鍚岄樁娈电敓浜ц繃绋嬩腑鐨勪骇鍝佸疄鏂藉贰妫??
2.3銆?浜у搧鍚庡姞宸ュ畬鎴愯嚦浜у搧鍖呰鐢变笓鑱孮C瀵逛骇鍝佸疄鏂芥壒閲忔娊锛團QC锛夛紝鍚?鏍煎啀杩涜鍖呰銆?br /> 2.4銆佸湪鍙戣揣鍓嶏紝鐢变笓鑱孮C瀵逛骇鍝佸疄鏂芥渶缁堟娊鏍锋鏌ワ紙OQC锛夛紝鍚堟牸 鍚庝氦鎴愬搧浠撳叆搴撳悗鎵ц鍙戣揣锛?br />3銆佸搧璐ㄧ籂姝e強鎸佺画鏀硅繘绛栫暐锛?br /> 3.1銆佸綋浜у搧鍦ㄧ敓浜ц繃绋嬩腑鎴栧嚭璐у悗鍙戠敓鍝佽川闂锛屽叕鍙镐細绔嬪嵆鐢卞搧璐ㄤ富瀵艰仈鍚屽伐绋嬬敓浜х瓑閮ㄩ棬瀵瑰搧璐ㄩ棶棰樿繘琛屽皬缁勮璁哄拰鍒嗘瀽锛屽悓鏃跺舰鎴?ldquo;涓嶅悎鏍煎搧鍒嗘瀽鏀瑰杽鎶ュ憡”鎴?ldquo;绾犳棰勯槻鎺柦鎶ュ憡”锛屽苟灏嗚繖浜涢棶棰樺弽棣堝埌鐩稿叧閮ㄩ棬杩涜鏀瑰杽鐫e楠岃瘉鍚屾椂鍥炲缁欏鎴枫?
3.2銆佸叕鍙镐細瀹氭湡鎴栦笉瀹氭湡褰㈠紡灞曞紑鐩稿叧鐨勫搧璐ㄤ笌鎶?湳鐨勮璁猴紝浠ユ寔缁敼杩涗骇鍝佸強鐩稿叧鐨勯」鐩繍钀ワ紝鎸佺画 鏀硅繘鍏徃鍚勬柟闈㈢殑绠$悊姘村钩锛屾洿澶ч檺搴︾殑鎻愬崌鍏徃浠ュ強婊¤冻瀹㈡埛瑕佹眰銆?/p> 浜ф潈淇濇姢锛?/strong>
1銆佸嚒鎴戝徃鑷富璁捐寮?彂骞跺紑妯$敓浜т骇鍝?鎴戝徃浜湁浜у搧鐩稿叧鐨勭煡璇嗘潈,浜у搧閿?敭鏉冨強瑙i噴鏉冦?2銆佹垜鍙搁?杩囧澶栧叕甯冪殑鐩稿叧浜у搧,鏈敞鏄庝骇鍝佸潎灞炲鎴锋彁渚涚浉鍏宠祫鏂欏苟鍦ㄥ鎴疯鍙笅杩涜鐢熶骇,鐩稿叧鐨勪骇鍝佺煡璇嗕骇鏉冨強鎵?湁鍧囧睘浜庡鎴蜂互鍙婅浜у搧鐨勫晢鏍囨寔鏈変汉銆?br />3銆佸鎴戝徃鑷富寮?彂璁捐鍙婃垜鍙稿鎴蜂骇鍝佹湁浠讳綍渚垫潈鍜屼笉褰撹涓?鎴戝徃浼氱ず鎯呭舰杩涜鐩稿叧璇夋眰鍙婃硶寰嬬▼搴忎互缁存姢鎴戝徃鍙婃垜鍙稿鎴峰埄鐩娿? 浠?箞鏄湁鏈恒?FDA璁よ瘉锛?/strong>鏈夋満璁よ瘉鏄湁鏈烘棤瀹充骇鍝佽璇佺殑绠?О銆傛湁鏈鸿璇佹槸鐩墠涓?簺鍥藉鍜屾湁鍏冲浗闄呯粍缁囪鍙苟澶у姏鎺ㄥ箍鐨勪竴绉嶄骇鍝佽璇佸舰寮忥紝涔熸槸鎴戝浗鍥藉璁よ瘉璁ゅ彲鐩戠潱绠$悊濮斿憳浼氱粺涓?鐞嗙殑璁よ瘉褰㈠紡涔嬩竴銆傛帹琛屾湁鏈轰骇鍝佽璇佺殑鐩殑锛屾槸鎺ㄥ姩鍜屽姞蹇湁鏈轰骇涓氱殑鍙戝睍锛屼繚璇佹湁鏈轰骇鍝佺敓浜у拰鍔犲伐鐨勮川閲忥紝婊¤冻娑堣垂鑰呭鏈夋満浜у搧鏃ョ泭澧為暱鐨勯渶姹傦紝鍑忓皯鍜岄槻姝㈡湁瀹崇墿璐ㄣ?鍖栧鎴愪唤绛夊啘鐢ㄥ寲瀛︾墿璐ㄥ拰鍐滀笟搴熷純鐗╁鐜鐨勬薄鏌擄紝淇冭繘绀句細銆佺粡娴庡拰鐜鐨勬寔缁彂灞曘? “FDA”鏄鍝佸拰鑽搧绠$悊灞?紙Food and Drug Administration锛夌殑鑻辨枃缂╁啓锛屾槸缇庡浗椋熷搧鑽墿绠$悊灞?殑鑻辨枃缂╁啓锛屽畠鏄浗闄呭尰鐤楀鏍告潈濞佹満鏋勶紝鐢辩編鍥藉浗浼氬嵆鑱旈偊鏀垮簻鎺堟潈锛屼笓闂ㄤ粠浜嬮鍝佷笌鑽搧绠$悊鐨勬渶楂樻墽娉曟満鍏炽?FDA鏄竴涓敱鍖荤敓銆佸緥甯堛?寰敓鐗╁瀹躲?鑽悊瀛﹀銆佸寲瀛﹀鍜岀粺璁″瀹剁瓑涓撲笟浜轰簨缁勬垚鐨勮嚧鍔涗簬淇濇姢銆佷績杩涘拰鎻愰珮鍥芥皯鍋ュ悍鐨勬斂搴滃崼鐢熺鍒剁殑鐩戞帶鏈烘瀯銆傞?杩嘑DA璁よ瘉鐨勯鍝併?鑽搧銆佸寲濡嗗搧鍜屽尰鐤楀櫒鍏峰浜轰綋鏄‘淇濆畨鍏ㄨ?鏈夋晥鐨勩?