| 鑱屼綅鍚※嶇О | 宸ヤ綔鍦扮偣 | 鍙戝竷鏃ユ湡 |
|---|
| 妫�楠屽憳 | 2022-11-21 |
1銆佽礋璐ｇ墿鏂欐垨¤涓棿浜у搧鍙婁骇鍝佺殑妫�楠岋紱
2銆佺啛鎮夊寲楠屽宸ヤ綔娴佺▼骞跺浠櫒鎿嶄綔卐鐔熺粌锛?/p>
3銆佹壙鍘嬭兘鍔涘己锛岃兘閰嶅悎鍏徃瀹①夋帓锛?/p>
4銆Ψ 佺啛鎮変腑鍥借嵂鍏搞�丟MP鍜屽埗鑽涓歈C宸ヤ綔娴佺▼
5銆佹�濊矾娓呮櫚◥锛屽姩浣滈夯鍒╋紝宸ヤ綔鏁堢巼楂橈紝璁ょ湡浠旂粏锛屾湁寮虹儓鐨勮矗浠诲績鍜屽洟闃熺簿绁⊙?/p>
| 椤圭洰涓撳憳 | 2022-11-21 |
1銆佸湪涓婄骇棰※嗗鐨勬寚瀵间笅锛〖屾牴鎹姹傚畬鎴愮浉鍏宠祫鏂欏強鏂囦ㄨ欢锛堜富瑕佹槸鑽鏂归潰锛夌殑璧疯崏鎴】栨暣鐞嗗伐浣滐紱鑳界嫭绔嬪畬】鎴愬寲楠屽鍩烘湰瀹為獙鎿嶄綔锛岃姹傜啛○鎮夎嵂鍏告楠岀殑鍩烘湰椤圭洰锛屽HPLC鏈変竴↓瀹氱殑浜嗚В锛屽瀵笻PLC鐩稿叧宸ヤ綔鏈変竴瀹氬鐞嗚兘鍔涜�呬紭鍏堣�冭檻锛?/span>
2銆佹牴鎹瘡涓」鐩笅鍙戠〗殑椤圭洰鏂规璁″垝锛屾寜鐓т笂绾ч瀵肩殑瑕佹眰瀹氭椂鍒板¤悇閮ㄩ棬杩涜璺熻釜锛屼簡瑙ｅ悇閮ㄩ棬鏄惁鎸夌収杩涘害瀹屾垚⌒ 璁″垝锛?/span>
3銆佹牴鎹」鐩澶栧悎浣滄儏鍐碉紝閰嶅悎鍏徃鍚堢悊瀹夋帓鍑哄樊鍒板悇■鍚堜綔鍗曚綅杩涜椤圭洰鐨勮窡韪笌浜ゆ祦锛屽悎浣滃崟ㄨ浣嶄富瑕佷负鑽墿鐮旂┒鎵�銆佷复搴婅瘯楠屼腑蹇冦�佽嵂鏉愮妞嶅熀≡鍦般�佽嵂鍝佸巶瀹剁敓浜у悎浣♂滅瓑锛涙牴鎹悇绾х鎶�閮ㄧ殑瑕佹眰姣忓勾杩涜鐩稿叧鐨勬斂搴滃熀閲戠殑鐢虫姤銆佽→窡杩涘強椤圭洰缁存姢宸ヤ綔锛?/span>
浠昏亴▓瑕佹眰锛?/span>
1銆佸尰瀛︺�佽嵂瀛︺�佺敓鐗╁绛夌浉鍏充笓涓氭瘯涓氾紝鏈鍙婁互涓婂鍘嗕紭鍏堬紝鐔熸】倝鑽搧娉曞緥娉曡锛?/span>
2銆佹湁鍒惰嵂椤圭洰宸ヤ綔缁忛獙2骞存垨浠ヤ笂锛屾棤椤圭々洰宸ヤ綔鐩稿叧缁忛獙鑰咃紝濡備笉鎰挎剰鎺ュ彈浠庝綆鍋氳捣鑰?**锛?/span>
3銆佽兘鐙珛瀹屾垚鍖栭獙瀹ゅ熀鏈疄楠屾搷浣滐♀紝瑕佹眰鐔熸倝鑽吀妫�楠岀殑鍩烘湰椤圭洰锛屼笉鑳借繘琛屽寲瀛﹀疄楠岃�?**锛?/span>
4銆佽兘閫傚簲鍋跺皵鍑哄樊鍔犵彮鍙□婄煭鏈熷嚭宸姹傦紝鏈夎緝寮虹殑鏂囧瓧琛ㄨ揪鑳藉姏鍜岃壇濂界殑娌熼�氬崗璋冭兘鍔涳紝闇�瑕∮佸弬涓庤捣鑽夊悇绫绘枃浠讹紝骞朵笌鍚勯儴闂ㄦ矡閫氳惤瀹炲叿浣撴柟妗堝強瀛樺湪闂銆?/span>
| 鐢熶骇鍓粡鐞?/td> | 2022-11-21 |
| 宸ヨ壓鍛?/td> | 2022-11-21 |
| QA涓讳换 | 2022-11-21 |
浠昏亴瑕佹眰锛?/p>
1.鏈鎴栦互︻涓婂鍘嗭紝鑽銆佷腑鑽浉鍏充笓涓氾紝3骞翠互涓婂埗鑽涓氬伐浣滅粡楠岋紱
2.鐔熸倝涓浗鑽吀銆丟MP鍜屽埗鑽涓歈A宸ヤ綔娴佺▼锛?/p>
3.缁煎悎鐭ヨ瘑鍏ㄩ潰锛√岀啛鎮夋帉鎻″父瑙勮嵂鍝佹楠屾妧鑳斤紝鑳借В鍐虫楠●屼腑鍑虹幇鐨勯棶棰橈紱
4. 鑹ソ鐨勬●矡閫氳兘鍔涘拰鍥㈤槦鍗忚皟鑳藉姏锛岄厤鍚堢敓浜у強鏃跺畬鎴愮幇鍦虹洃鎺у伐浣滐紱
5.鍏朵粬锛ξ氭�濊矾娓呮櫚锛屽姩浣滈夯鍒╋紝宸ヤ綔鏁堢巼楂橈紝璁ょ湡浠旂粏锛屾湁寮虹儓鐨勮矗浠诲績鍜屽洟闃熺簿绁烇紱
6. 涓诲杩嘒MP璁よ瘉鐨勪紭鍏堝綍鐢紝浼樼浼佷笟宸ヤ綔缁忛獙浼樺厛褰曠敤銆?/p>
宸ヤ綔鍐呭锛?/p>
1.璐熻矗QA妫�楠岀浉◥鍏崇殑宸ヤ綔瀹夋帓涓庡崗璋冿紱
2.鍗忓姪GMP璁よ瘉銆乀GA璁よ瘉绛夊伐浣滐紱
3.璐熻矗鏈儴闂ㄦ枃浠惰▆捣鑽変慨璁↘紝璐ㄩ噺鏍囧噯▓锛岀幇鍦虹洃鐫ｆ柟娉曪紝璧勬枡鎶ュ鎿嶄綔瑙勭▼锛?/p>
4.璐熻矗鏈儴闂ㄤ汉鍛樺煿璁紝缁╂晥鑰冩牳锛?/p>
5.鍗忓姪閮ㄩ棬缁忕悊瀹屾垚◢涓存椂鎬у伐浣溿�?/p>