缇庡湅(gu贸)閱�(y墨)鐧傚櫒姊癎MP瑾�(r猫n)璀夌啊(ji菐n)浠�

寮曡█:鑰冩叜鍒癎MP瑾�(r猫n)璀夐€欏€�(g猫)瑭�锛屽湪涓嶅悓瑾�(y菙)澧�銆佷笉鍚屽湅(gu贸)瀹跺拰鍦板崁(q奴)鐨勬剰缇╁樊鍒ュ緢澶�锛屽苟涓旇繎鏈熸湁瀹㈡埗(h霉)鍟�(w猫n)鍒伴啱(y墨)鐧傚櫒姊癎MP820瑾�(r猫n)璀夈€傚洜姝�锛屽(xi臎)绡囨枃绔犵偤澶у绉戞櫘涓€涓嬬編鍦�(gu贸)閱�(y墨)鐧傚櫒姊癎MP瑾�(r猫n)璀夛紝鍗虫槸QSR820鑹ソ鐢熺敘(ch菐n)瑕�(gu墨)鑼冿紙21CFR820妯�(bi膩o)婧�(zh菙n)锛�銆�

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缇庡湅(gu贸)閱�(y墨)鐧傚櫒姊癎MP瑾�(r猫n)璀�QSR820鑹ソ鐢熺敘(ch菐n)瑕�(gu墨)鑼冿紙21CFR820妯�(bi膩o)婧�(zh菙n)锛�

缇庡湅(gu贸)閱�(y墨)鐧傚櫒姊癎MP璩�(zh矛)閲忕郴绲�(t菕ng)瑕�(gu墨)绔狅紙21CFR820锛夛細
A- 涓€鑸(gu墨)瀹�
1. 鑼冨湇
閱�(y墨)鐧傚櫒姊扮殑瑷�(sh猫)瑷�(j矛)銆佸埗閫犮€佸寘瑁�銆佽布绨�銆佸劜(ch菙)瀛�銆佸畨瑁濆拰缍慨锛�
锛圛椤�(l猫i)瑁濈疆鍍呴仼鐢ㄤ簬鍒楀嚭鐨勯儴鍒嗭級銆�
2. 瀹氱京
鎶曡ù銆佹垚鍒�銆佹帶鍒惰櫉(h脿o)纰�銆佽ō(sh猫)瑷�(j矛)姝峰彶妾旀銆佽ō(sh猫)瑷�(j矛)杓稿叆銆佽ō(sh猫)瑷�(j矛)杓稿嚭銆佹鍙茶閷勩€佷富瑷橀寗銆侀潪涓€鑷存€�銆佽唱(zh矛)閲忓瑷�(j矛)銆�
B- 璩�(zh矛)閲忕郴绲�(t菕ng)瑕佹眰
1. 绠＄悊鑱疯铂(z茅)
璩�(zh矛)閲忔柟閲� 銆佺祫绻斻€佺鐞嗘鏌�銆佽唱(zh矛)閲忚▓(j矛)鍔�銆佽唱(zh矛)閲忕郴绲�(t菕ng)瑕�(gu墨)绋嬶紱
2. 璩�(zh矛)閲忓瑷�(j矛)
璩�(zh矛)閲忓瑷�(j矛)瑕�(gu墨)绋�銆佽铂(z茅)浠讳汉銆佺尘閷�(cu貌)琛岀偤銆�
3. 浜哄摗
缍�(j墨ng)椹�(y脿n)銆佸煿瑷�(x霉n)銆�
C- 瑷�(sh猫)瑷�(j矛)鎺у埗
涓€鑸姹�銆佽ō(sh猫)瑷�(j矛)鍜岄枊(k膩i)鐧�(f膩)瑷�(j矛)鍔冦€佽ō(sh猫)瑷�(j矛)杓稿叆銆佽ō(sh猫)瑷�(j矛)杓稿嚭銆佽ō(sh猫)瑷�(j矛)妾㈡煡銆佽ō(sh猫)瑷�(j矛)纰鸿獚(r猫n)銆佽ō(sh猫)瑷�(j矛)椹�(y脿n)璀夈€佽ō(sh猫)瑷�(j矛)杞�(zhu菐n)璁�銆佽ō(sh猫)瑷�(j矛)璁婂寲銆佽ō(sh猫)瑷�(j矛)姝峰彶妾旀銆�
D- 鏂囦欢鎺у埗
鏂囦欢鎵规簴(zh菙n)鍜屽垎鐧�(f膩)銆佹枃浠惰畩鍖�銆�
E- 閲囪臣(g貌u)鎺у埗
渚涙噳(y墨ng)鍟嗐€佸悎鍚屽晢銆侀¨鍟�(w猫n)鐨勮⿻(p铆ng)鍍�(ji脿)銆侀噰璩�(g貌u)璩囨枡銆�
F- 閼掑畾鍜屽彲杩芥函鎬�
G- 鐢熺敘(ch菐n)鍜岄亷(gu貌)绋嬫帶鍒�
1. 鐢熺敘(ch菐n)鍜岄亷(gu貌)绋嬫帶鍒�
涓€鑸姹�銆佺敓鐢�(ch菐n)鍜屽伐钘濊畩鍖栥€佺挵(hu谩n)澧冩帶鍒�銆佷汉鍝�銆佹薄鏌撴帶鍒躲€佸粻(ch菐ng)鎴�銆佽ō(sh猫)鍌欍€佸埗閫犳潗鏂�銆佽嚜鍕�(d貌ng)鍖栭亷(gu貌)绋嬶紱
2. 妾㈡煡銆佹脯(c猫)閲忓拰瀵�(sh铆)椹�(y脿n)瑁濆倷
妾㈡煡銆佹脯(c猫)閲忓拰妾㈤(y脿n)瑁濆倷鐨勬帶鍒�銆佹牎婧�(zh菙n)锛�
3.宸ヨ棟椹�(y脿n)璀�
H- 鎺ュ彈琛岀偤
1.鎺ユ敹銆佷腑闁撻亷(gu貌)绋嬪拰鏈€绲傞啱(y墨)鐧傚櫒姊版帴鍙�
2.鎺ュ彈鐙€娉�
I-闈炰竴鑷存€х殑鐢�(ch菐n)鍝�
J- 绯鹃尟(cu貌)鍜岄爯(y霉)闃茶鐐�
K- 璨肩敖鍜屽寘瑁濇帶鍒�
1.閱�(y墨)鐧傚櫒姊扮殑妯�(bi膩o)绨�
2.閱�(y墨)鐧傚櫒姊扮殑鍖呰
L- 鎼亱(y霉n)銆佸劜(ch菙)钘�銆侀姺(xi膩o)鍞拰瀹夎
1.鎼亱(y霉n)
2.鍎�(ch菙)钘�
3.閵�(xi膩o)鍞�
4.瀹夎
M- 瑷橀寗
1.涓€鑸姹�
2.閱�(y墨)鐧傚櫒姊颁富瑷橀寗
3.閱�(y墨)鐧傚櫒姊版鍙茶閷�
4.璩�(zh矛)閲忕郴绲�(t菕ng)瑷橀寗
5.鎶曡ù妾旀
N- 缍慨
O- 绲�(t菕ng)瑷�(j矛)瀛�(xu茅)鎶€琛�(sh霉)

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