1
鐩殑
(
Purpose
)
瀵圭洂閰歌嫰閭ｆ櫘鍒?/p>
USP
鍚噺鏈夊叧鐗╄川鍒嗘瀽鏂规硶杩涜鏂规硶纭銆?/p>
2
鑼冨洿
(
Scope
)
2.1
鍚噺鍒嗘瀽娉曠殑纭鍐呭鍖呮嫭鏂规硶鐨勪笓灞炴�у拰閲嶇幇鎬с�?/p>
2.2
鏈夊叧鐗╄川鍒嗘瀽娉曠敱涓や釜瀹為獙鏋勬垚锛?/p>
Test
1
锛氳嫰閭ｆ櫘鍒╂潅璐?/p>
A
锛?/p>
Test
2
锛氳嫰閭ｆ櫘鍒╂潅璐?/p>
B
锛?/p>
C
锛?/p>
D
锛?/p>
E
锛?/p>
F
锛屽拰
G
銆?/p>
鏈夊叧鐗╄川鍒嗘瀽娉曠殑纭鍐呭鍖呮嫭鏂规硶鐨勪笓灞炴�э紝鏂规硶鐨勯噸鐜版�э紝鍜屽畾閲忛檺
(LOQ)
銆?/p>
2.3
鎵�閰嶅惈閲忔爣鍑嗘憾娑插拰鏍峰搧婧舵恫鐨勭ǔ瀹氭�т篃灏嗕簣浜庤�冨療銆?/p>
3
鑱岃矗
(
Responsibilities
)
3.1
璐ㄩ噺绠＄悊閮紙
QA Dept.
锛?/p>
QA
缁忕悊璐熻矗楠岃瘉鏂规鍜屾姤鍛婄殑鎵瑰噯锛涜礋璐ｇ洃鐫ｇ鐞嗘暣涓‘璁ゆ椿鍔紝纭繚纭鎸夎繘搴﹁鍒掕繘琛屻�?/p>
QA
浜哄憳璐熻矗杩囩▼鐩戠潱锛岀‘淇濇寜鎵瑰噯鐨勬柟妗堣繘琛岋紝纭繚璐ㄩ噺绠＄悊鐨勫師鍒欎綋鐜板湪纭杩囩▼涔嬩腑銆?/p>
3.2
娉ㄥ唽閮?/p>
瀹℃牳鏂规鍜屾姤鍛婁笌
cGMP
鐨勭鍚堟�с�?/p>
3.3
鍖栭獙瀹わ紙
QC Dept.
锛?/p>
璐熻矗纭鏂规鐨勮捣鑽夛紝纭杩囩▼鐨勫疄鏂斤紝骞跺畬鎴愰獙璇佹姤鍛娿�?/p>
4
纭璇曢獙鎵�鐢ㄦ爣鍑嗗搧鍜屾牱鍝?/p>
(
Test Articles
)
4.1
鏍囧噯鍝?/p>
USP
鐩愰吀鑻偅鏅埄宸ヤ綔瀵圭収鍝侊紝鎴栨槍鏄庤嚜鍒跺伐浣滃鐓у搧
USP
鐩愰吀鑻偅鏅埄鏈夊叧鐗╄川
A
锛?/p>
B
锛?/p>
C
锛?/p>
D
锛?/p>
E
锛?/p>
F
锛?/p>
G
宸ヤ綔瀵圭収鍝侊紝鎴栨槍鏄庤嚜鍒跺伐浣滃鐓у搧銆?/p>
4.2
鏍峰搧
鐩愰吀鑻偅鏅埄锛屾壒鍙?/p>
锛涚敓浜у巶瀹讹細娴欐睙鏄屾槑鑽笟鏈夐檺鍏徃
5
鍚噺鍒嗘瀽鏂规硶纭璇曢獙锛?/p>
Verification For Assay method
锛?/p>
5.1
鍚噺鍒嗘瀽鏂规硶閲嶇幇鎬?/p>
5.1.1
璇曢獙
5.1.1.1
QC
妫�楠屽憳鎸夌収闄勫綍鍚噺鍒嗘瀽鏂规硶鐢ㄧ浉鍚屾壒鐨勭洂閰歌嫰閭ｆ櫘鍒?/p>
(
鎵瑰彿
:
)
閰嶅埗
6
涓洂閰歌嫰閭ｆ櫘鍒╀緵
璇曞搧婧舵恫銆?/p>
5.1.1.2
鎸夌収闄勫綍鍚噺鍒嗘瀽鏂规硶
(
HPLC
)
瀵规瘡涓牱鍝佹憾娑茶繘琛屽惈閲忓垎鏋愩�傛寜鐓ч檮褰曞惈閲忓垎鏋愭柟娉曡瀹氱殑杩?/p>
鏍风▼搴忚繘鏍枫�傛瘡涓牱鍝佹憾娑查噸澶嶈繘鏍蜂袱閽堬紝骞朵笖姣忛殧
12
閽堟牱鍝佹憾娑插拰杩涙牱绋嬪簭瀹屾垚鍚庤繘
1
閽堢▼搴忔帶鍒?/p>
鏍囧噯鍝佹憾娑层�?/p>
5.1.2
鏁版嵁鏈夋晥鎬ф爣鍑?/p>
5.1.2.1
婊¤冻闄勫綍鍚噺鏂规硶瑙勫畾鐨勭郴缁熼�傚簲鎬ц姹?/p>