璇存槑锛氫负缂╃煭绡囧箙锛屽ぇ澶氭暟鐨勯棶绛旈鍜岀畝绛旈鐨勭瓟妗堝彧缁欏嚭浜嗙瓟棰樿鐐广�傜孩瀛楁槸绛旀銆?/p>
锛堝鏈夐敊璇紝璇锋寚姝ｏ級
绗竴绔?/p>
鑽吀姒傚喌
(
鍚华璁?/p>
)
涓�銆佸～绌洪
1
锛?/p>
涓浗鑽吀鐨勪富瑕佸唴瀹圭敱
鍑′緥
銆?/p>
姝ｆ枃
銆?/p>
闄勫綍
鍜?/p>
绱㈠紩
鍥涢儴鍒嗙粍鎴愩�?/p>
2
锛?/p>
鐩墠鍏鐨勫叏闈㈡帶鍒惰嵂鍝佽川閲忕殑娉曡鏈?/p>
GLP
銆?/p>
GMP
銆?/p>
GSP
銆?/p>
GCP
銆?/p>
3
锛?/p>
鈥滅簿瀵嗙О瀹氣�濈郴鎸囩О鍙栭噸閲忓簲鍑嗙‘鑷虫墍鍙栭噸閲忕殑
鍗冨垎涔嬩竴
锛?/p>
鈥滅О瀹氣�濈郴鎸囩О鍙栭噸閲忓簲鍑嗙‘鑷?/p>
鎵�鍙栭噸閲忕殑
鐧惧垎涔嬩竴
锛涘彇鐢ㄩ噺涓衡�滅害鈥濊嫢骞叉椂锛岀郴鎸囧彇鐢ㄩ噺涓嶅緱瓒呰繃瑙勫畾閲忕殑
卤
10
锛?/p>
銆?/p>
4
锛?/p>
鑽墿鍒嗘瀽涓昏鏄噰鐢?/p>
鐗╃悊瀛︺�?/p>
鍖栧銆?/p>
鐗╃悊鍖栧
鎴?/p>
鐢熺墿鍖栧
绛夋柟娉曞拰鎶�鏈紝鐮旂┒鍖栧
缁撴瀯宸茬煡鐨勫悎鎴愯嵂鐗╁拰澶╃劧鑽墿鍙婂叾鍒跺墏鐨勭粍鎴愩�佺悊鍖栨�ц川銆佺湡浼壌鍒�佺函搴︽鏌ヤ互鍙婃湁鏁堟垚
鍒嗙殑鍚噺娴嬪畾绛夈�傛墍浠ワ紝鑽墿鍒嗘瀽鏄竴闂?/p>
鐮旂┒鑽搧鍏ㄩ潰璐ㄩ噺鎺у埗
鐨勬柟娉曟�у绉戙�?/p>
5
锛?/p>
鍒ゆ柇涓�涓嵂鐗╄川閲忔槸鍚︾鍚堣姹傦紝蹇呴』鍏ㄩ潰鑰冭檻
_
閴村埆
_
銆?/p>
_
妫�鏌?/p>
_
銆?/p>
_
鍚噺娴嬪畾
涓夎�呯殑妫�楠岀粨鏋溿�?/p>
6
锛?/p>
鑽墿鍒嗘瀽鐨勫熀鏈换鍔℃槸妫�楠岃嵂鍝佽川閲忥紝淇濋殰浜烘皯鐢ㄨ嵂
_
瀹夊叏
_
銆?/p>
_
鍚堢悊
_
銆?/p>
_
鏈夋晥
_
鐨勯噸瑕佹柟闈€�?/p>
浜屻�侀�夋嫨棰?/p>
1
锛?/p>
銆婅嵂鍝佺敓浜ц川閲忕鐞嗚鑼冦�嬪彲鐢?/p>
(
D
)
琛ㄧず銆?/p>
(A)USP (B)GLP (C)BP
(D)GMP
(E)GCP
2
锛?/p>
鑽墿鍒嗘瀽璇剧▼鐨勫唴瀹逛富瑕佹槸浠?/p>
(
D
)
(A)
鍏被鍏稿瀷鑽墿涓轰緥杩涜鍒嗘瀽
(B)
鍏被鍏稿瀷鑽墿涓轰緥杩涜鍒嗘瀽
(C)
涔濈被鍏稿瀷鑽墿涓轰緥杩涜鍒嗘瀽
(D)
涓冪被鍏稿瀷鑽墿涓轰緥杩涜鍒嗘瀽
(E)
鍗佺被鍏稿瀷鑽墿涓轰緥杩涜鍒嗘瀽
3
锛?/p>
銆婅嵂鍝佷复搴婅瘯楠岃川閲忕鐞嗚鑼冦�嬪彲鐢?/p>
(
C
)
琛ㄧず銆?/p>
(A)GMP (B)GSP
(C)GLP
(D)TLC (E)GCP
4
锛?/p>
鐩墠锛?/p>
銆婁腑鍗庝汉姘戝叡鍜屽浗鑽吀銆嬬殑鏈�鏂扮増涓?/p>
(
C
)
(A)2000
骞寸増
(B)2003
骞寸増
(C)2005
骞寸増
(D)2007
骞寸増
(E)2009
骞寸増
5
锛?/p>
鑻卞浗鑽吀鐨勭缉鍐欑鍙蜂负
(
B
)
銆?/p>
(A)GMP
(B)BP
(C)GLP (D)RP
锛?/p>
HPLC (E)TLC
6
锛?/p>
缇庡浗鍥藉澶勬柟闆嗙殑缂╁啓绗﹀彿涓?/p>
(
D
)
銆?/p>
(A)WHO (B)GMP (C)INN
(D)NF
(E)USP
7
锛?/p>
GMP
鏄寚
(
B
)
(A)
鑽搧闈炰复搴婄爺绌惰川閲忕鐞嗚鑼?/p>
(B)
鑽搧鐢熶骇璐ㄩ噺绠＄悊瑙勮寖
(C)
鑽搧缁忚惀璐ㄩ噺绠＄悊瑙勮寖
(D)
鑽搧涓村簥璇曢獙璐ㄩ噺绠＄悊瑙勮寖
(E)
鍒嗘瀽璐ㄩ噺绠＄悊
8
锛?/p>
鏍规嵁鑽搧璐ㄩ噺鏍囧噯瑙勫畾锛岃瘎浠蜂竴涓嵂鍝佺殑璐ㄩ噺閲囩敤
(
A
)
(A)
閴村埆锛屾鏌ワ紝璐ㄩ噺娴嬪畾
(B)
鐢熺墿鍒╃敤搴?/p>
(C)
鐗╃悊鎬ц川
(D)
鑽悊浣滅敤
涓夈�侀棶绛旈
1
锛?/p>
鑽搧鐨勬蹇碉紵瀵硅嵂鍝佺殑杩涜璐ㄩ噺鎺у埗鐨勬剰涔夛紵