Ñӱ߱±¾©×¢²á¹«Ë¾(ÑÓ±ß×¢²á¹«Ë¾Á÷³Ì)
- À¸Ä¿£º±±¾©×¢²á¹«Ë¾
- À´Ô´£ºÍøÂç
- ·¢±íʱ¼ä£º2023-05-11
±¾ÎÄÖ÷Òª½²½âÁË¡¾Ñӱ߱±¾©×¢²á¹«Ë¾¡¿µÄÏà¹ØÄÚÈÝ£¬´ÓÑÓ±ß×¢²á¹«Ë¾Á÷³Ì£¬Ñӱ߹«Ë¾×¢²á´úÀí£¬ÑÓ¼ªÊÐ×¢²á¹«Ë¾£¬²»Í¬·½Ãæ²ûÊöÁËÔõôÏà´¦µÄ·½·¨£¬Ö÷Ҫͨ¹ý²½ÖèµÄ·½Ê½À´½²½â£¬Ï£ÍûÄܰïÖúµ½´ó¼Ò
1¡¢Ñӱߴú°ìµç»°(Ãâ·Ñ×Éѯ)¡£ÑÓ±ß×¢²á¹«Ë¾¹«Ë¾×¢²á>¼ªÁÖ>Ñӱߡ£¿´Ò»Íò´Î²»ÈçÎÊÒ»´Î¡¢ÓÐʲôÎÊÌâ¿ÉÒÔÖ±½Ó×ÉѯÎÒÃÇ¡¢¹¤ÉÌ×¢²áÏà¹ØÕþ²ßÃâ·Ñ×Éѯ¡¢Ãâ·Ñ¹¤É̲éÃû¡£É¨Ò»É¨Ï·½¶þάÂë²é¿´¸ü¶à±¾µØ¹¤ÉÌ´ú°ì»ú¹¹¡£ÄÚ×ʹ«Ë¾×¢²á¡¢Íâ×ʹ«Ë¾×¢²á¡¢¼¯ÍŹ«Ë¾×¢²á¡¢·Ö¹«Ë¾×¢²á¡¢0Ôª¿ìËÙ×¢²áÖÜÆÚ¶Ì£¬·ÑÓõ;ܾøÒþÐÎÏû·ÑÒ»¶ÔһרÊô·þÎñ
2¡¢
3¡¢
ÑÓ±ß×¢²á¹«Ë¾Á÷³ÌÑÓ±ß×¢²á¹«Ë¾Á÷³Ì¼°·ÑÓá£Ïò¹¤É̾ÖÉêÇ빫˾Ãû³ÆºË×¼¡£Í¨¹ýºóÁìÈ¡£º"ÆóÒµÃû³ÆÔ¤ÏȺË׼֪ͨÊé"¡£µã»÷->¹¤É̾ÖÍøÉÏÆóÒµÃû³ÆÉêÇëÈë¿Ú¡£µã»÷->ÆóÒµÃû³ÆºË×¼²Ù×÷ÊÓÆµ½Ì³Ì¡£µã»÷->ÆóÒµÉèÁ¢²Ù×÷ÊÓÆµ½Ì³Ì¡£µã»÷->ÆóÒµÃû³ÆÔ¤ÏȺË×¼ÉêÇë±íÏÂÔØ
ANVISA¼°Êг¡Ó빤³§Ö®¼äµÄÁªÏµºÍת´ï¡£2ÊÚȨ¹¤³§µÄ°ÍÎ÷¾ÏúÉÌÁ÷³Ì£ºÃ¿´ÎÊÚȨ500ÃÀ½ð¡£°ÍÎ÷ANVISAÒ½ÓÿÚÕÖÈÏÖ¤ÉêÇëÁ÷³Ì¡£²½Öè1°´ÕÕ,¶Ô²úÆ·½øÐзÖÀà,Ò»°ã»áÓÐ2ÖÖ×¢²á·½Ê½:µÇ¼Ç»òÕß×¢²á¡£µÍ·çÏÕµÄ1ÀàºÍ2ÀàÒ»°ãÊôÓÚ¼òµ¥µÇ¼Ç,µ«¸ß·çÏÕµÄ1ÀàºÍ2Àà,ÒÔ¼°ËùÓеÄ3Àà,4Àà²úÆ·,ÊÇÊôÓÚÍêÕûµÄ×¢²á£¨µÇ¼ÇºÍ×¢²áµÄÇø±ðÔÚÓÚÊÇ·ñÒªBGMPÑé³§£©
²½Öè2*Ò»¸ö¹«Ë¾³ÉΪÄãµÄÖ¤Êé³ÖÓÐÈË(BRH)¡£¹úÍâÖÆÔìÉÌ¿ÉÒÔͨ¹ýÕâ¸öÍйܵÄBRH¡£½øÐÐÊÚȨ°ÍÎ÷¾ÏúÉ̽ø¿ÚºÍÏúÊÛ²úÆ·.¡£²½Öè3ÊÚȨBRHÌá½»×¢²áÉêÇëºÍÎļþ×ÊÁϸøANVISA¡£ÄãµÄBRH½«Î¬»¤×¢²áºÍ±£³Ö¡£BGMP(Ö»ÊÊÓÃÐèÒªBGMPµÄ¿Í»§)
Ñӱ߹«Ë¾×¢²á´úÀí¾Óª·¶Î§°üº¬£º²ÆÎñÐÅÏ¢×Éѯ·þÎñ¡£Ñӱ߹ã»Û²ÆÎñ×ÉѯÓÐÏÞ¹«Ë¾¡£±¾µØ»á¼Æ´ú°ì×¢Ïú¡¢¹«Ë¾×¢²áÌṩÄÚ×ʹ«Ë¾×¢²á·þÎñ¡£¾ßÓвÆÕþ¾Ö±¸°¸µÄרҵ´úÀí¼ÇÕË»ú¹¹¡£¹²Ó®ÆóÒµ¹ÜÀí×ÉѯÓÐÏÞ¹«Ë¾¡£Ãâ·Ñ´úÕ˱¨Ë°ºÍ°ìÀí¹«Ë¾×¢²á¡£ÑÓ±ß˰ÓÅÖÇÔÆË°Îñ·þÎñÓÐÏÞ¹«Ë¾
Ñӱ߯óÊÂͨ²ÆÎñ´úÀíÓÐÏÞ¹«Ë¾¡£×¨Òµ´úÊÕÕʹ«Ë¾×¢²áÌṩÄÚ×ʹ«Ë¾×¢²á¡¢Íâ×ʹ«Ë¾×¢²áµÈ¡£ÑÓ±ßÃûÊË´ï²ÆÎñ²ß»®ÓÐÏÞ¹«Ë¾¡£ÅÄÂô¾ÓªÐí¿ÉÖ¤¡¢Î£ÏÕ»¯Ñ§Æ·Ðí¿ÉÖ¤×ÊÖÊÈÏÖ¤ÌṩͼÊéÒô¡£É½¶«°ïÀϰåÆóÒµ·þÎñÓÐÏÞ¹«Ë¾¡£²ÆË°·þÎñ£¬´úÀí¼ÇÕË£¬ÈËÊ´úÀí£¬ÒµÎñ
ÑÓ¼ªÊÐ×¢²á¹«Ë¾ÀîÕÜÃñ£¨ÑÓ¼ªÊÐÊÀ¶û±ÈÃñËײÍÌü·¨ÈË£©¡£ÑÓ¼ªÊÐÊÀ¶û±ÈÃñËײÍÌü¡£ÑÓ¼ªÊоÖ×Ó½Ö4566ºÅºÏ×÷Ð¡Çø21ºÅÂ¥1006¡£ÀîÕÜÃñ£¨ÑÓ¼ªÊÐСÃñÌúÀϺ«Ìú°åöÏÓãµê·¨ÈË£©¡£ÑÓ¼ªÊÐСÃñÌúÀϺ«Ìú°åöÏÓãµê¡£ÑÓ¼ªÊбõºÓÐ¡ÇøºÅ£¨Ô°·ÄÉçÇø£©
ÀîÕÜÃñ£¨ÑÓ¼ªÊÐÆøÉ½Ðĺ£Ð¡´®µê·¨ÈË£©¡£ÑÓ¼ªÊÐÆøÉ½Ðĺ£Ð¡´®µê¡£ÑÓ¼ªÊбõºÓÐ¡ÇøºÅ£¨Ô°·ÄÉçÇø£©¡£ÀîÕÜÃñ£¨ÑÓ±ßÊÀ¶û±È²ÍÒû¹ÜÀíÓÐÏÞ¹«Ë¾·¨ÈË£©¡£ÑÓ±ßÊÀ¶û±È²ÍÒû¹ÜÀíÓÐÏÞ¹«Ë¾¡£ÑÓ¼ªÊоÖ×Ó½Ö4566ºÅºÏ×÷Ð¡Çø21ºÅÂ¥1006
ÀîÕÜÃñ-·¨ÈËÀîÕÜÃñÔÚ¼ªÁÖ×¢²áµÄËùÓй«Ë¾¡£ÏëÁ˽ⷨÈËÀîÕÜÃñÔÚ¼ªÁÖ×¢²áµÄ¹«Ë¾£¬ÀîÕÜÃñÃûÏÂËùÓй«Ë¾ÐÅÏ¢¡£¼ªÁÖй¤ÉÌÃû¼ΪÄúÌṩ·¨ÈËÀîÕÜÃñÔÚ¼ªÁÖ×¢²áµÄËùÓй«Ë¾µØÖ·¡¢µç»°¡¢ÁªÏµ·½Ê½¡¢×¢²áÈÕÆÚ¡¢¾Óª·¶Î§µÈÏêϸÐÅÏ¢¡£(ÀîÕÜÃñÔÚ¼ªÁÖ×¢²áµÄ¹«Ë¾ÏÂÔØÀîÕÜÃñÔÚÈ«¹ú×¢²áµÄ¹«Ë¾ÏÂÔØ)
ÒòΪÈËÃûÓÐͬÃûµÄÇé¿ö´æÔÚ£¬Èç¹ûÐèҪ׼ȷ²éÕÒÁбíÖС°Ä³¸ö¹«Ë¾¡±µÄ·¨ÈË¡¶ÀîÕÜÃñÃûÏÂ×¢²áµÄËùÓÐÆóÒµ¡·£¬¿ÉÒÔµã»÷ÏÂÃæµÄ¡°¸¶·Ñ²éѯ¡±Á´½Ó¡£(ÀîÕÜÃñÔÚ¼ªÁÖ×¢²áµÄ¹«Ë¾ÏÂÔØÀîÕÜÃñÔÚÈ«¹ú×¢²áµÄ¹«Ë¾ÏÂÔØ)¡£ÒòΪÈËÃûÓÐͬÃûµÄÇé¿ö´æÔÚ£¬Èç¹ûÐèҪ׼ȷ²éÕÒÁбíÖС°Ä³¸ö¹«Ë¾¡±µÄ·¨ÈË¡¶ÀîÕÜÃñÃûÏÂ×¢²áµÄËùÓÐÆóÒµ¡·£¬¿ÉÒÔµã»÷ÏÂÃæµÄ¡°¸¶·Ñ²éѯ¡±Á´½Ó
ÒÔÉϾÍÊÇÈ«²¿¹ØÓÚ¡¾Ñӱ߱±¾©×¢²á¹«Ë¾¡¿µÄÈ«²¿ÄÚÈÝ£¬°üº¬ÁËÒÔÉϵö²»Í¬·½Ã棬Èç¹ûÓÐÆäËûÒÉÎÊ£¬»¶ÓÁôÑÔ¡£
Ñӱ߱±¾©×¢²á¹«Ë¾(ÑÓ±ß×¢²á¹«Ë¾Á÷³Ì)Ïà¹ØÔĶÁ£º
±±¾©ÑøÀÏ·þÎñ¹«Ë¾×¢²áÐèÒª(±±¾©ÑøÀÏ·þÎñ¹«Ë¾×¢²áÐèÒª¶àÉÙÇ®)
±±¾©×¢²áÒ»¸ö´«Ã½¹«Ë¾(±±¾©×¢²áÒ»¸ö´«Ã½¹«Ë¾ÐèÒª¶àÉÙÇ®)
±±¾©¹«Ë¾×¢²á±¨¼Û(±±¾©¹«Ë¾×¢²á±¨¼Û²éѯ)
±±¾©×¢²á¹«Ë¾Ò»°ãÒª¶àÉÙÇ®(±±¾©×¢²á¹«Ë¾Ò»°ãÒª¶àÉÙǮһÄê)
±±¾©¹«Ë¾×¢²áÍÆ¼öÄļÒ(±±¾©¹«Ë¾×¢²áÍÆ¼öÄļÒÒøÐÐ)
±±¾©Éè¼Æ¹«Ë¾×¢²áÁ÷³Ì(±±¾© Éè¼Æ¹«Ë¾)
±±¾©¹«Ë¾×¢²áºËÃûÁ÷³Ì(±±¾©¹«Ë¾×¢²áºËÃûÁ÷³Ìͼ)
±±¾©ÈÚ×Ê×âÁÞ¹«Ë¾×¢²áÌõ¼þ(±±¾©ÈÚ×Ê×âÁÞÓÐÏÞ¹«Ë¾×¢²áÁ÷³Ì)
ÔÚ±±¾©°ì¹«Â¥×¢²á¹«Ë¾(ÔÚ±±¾©°ì¹«Â¥×¢²á¹«Ë¾Òª¶àÉÙÇ®)
±±¾©½¼ÇøÎÞµØÖ·×¢²á¹«Ë¾(2020±±¾©ÎÞµØÖ·×¢²á¹«Ë¾)
- ÇëÍÆ¼öÒ»¼Òרҵˮƽ¸ßµÄ±±¾©×¢²á¹«Ë¾¡£
- ÇëÎÊһϱ±¾©¹«Ë¾×¢²áµÄƽ¾ù¼Û¸ñÊǶàÉÙ£¿
- Î÷Äþ×¢²á¹«Ë¾ËùÐè²ÄÁÏ,Î÷Äþ×¢²á¹«Ë¾Á÷³ÌÏê½â
- ËÕÖÝ×¢²á¹«Ë¾Ñ¡Äĸö£¿ËÕÖÝÊÐ×¢²á¹«Ë¾ÄļҺã¿
- Î÷°²×¢²á¹«Ë¾×¢²á×ʽð±ä¸üµÄ¾ßÌå²½ÖèºÍ×¢ÒâÊÂÏî
- ×¢²áÂÌ»¯ÊÐÕþ¹«Ë¾£¨°ìÀíÂÌ»¯ÊÐÕþ¹«Ë¾×¢²áÁ÷³Ì£©
- ÃÀ¹ú×¢²á¹«Ë¾¶À×Ê£¨ÃÀ¹ú¹«Ë¾×¢²áÁ÷³Ì¼°¶À×ʾӪ£©
- ºÊÔóÌÔ±¦×¢²á¹«Ë¾£¨°ìÀíÌÔ±¦µêÆÌ×¢²áÏà¹ØÊÂÒË£©
- ·¬Ø®×¡Õ¬×¢²á¹«Ë¾£¨·¬Ø®µØÇø×¡Õ¬ÆóÒµ×¢²áÖ¸ÄÏ£©
- Óª¿Ú×¢²á±±¾©¹«Ë¾ÐèÒªÄÄЩÊÖÐøºÍÌõ¼þ£¿
- ËÕÖÝ×¢²á¹«Ë¾ÐèÒªÄÄЩÊÖÐø£¨Ïêϸ°ìÀíÁ÷³Ì½éÉÜ£©
- ÁÉÑô×¢²á¿Æ¼¼¹«Ë¾£¨ÁÉÑôÊÐ×¢²á¿Æ¼¼¹«Ë¾°ìÀíÁ÷³Ì£©
- ·µÇ®·þÎñÄÜ·ñÌá¸ß±±¾©×¢²á¹«Ë¾µÄ¾ºÕùÁ¦£¿
- Öî³Ç¹«Ë¾×¢²áÁ÷³ÌÏê½â,Öî³Ç¹«Ë¾×¢²áÐèÒªÄÄЩ²ÄÁÏ
- ÄÜ×Ô¼º×¢²á¹«Ë¾Âð,×ÔÖú×¢²á¹«Ë¾µÄ²½ÖèºÍ×¢ÒâÊÂÏî
- ÖÆÔìÒµ¹«Ë¾×¢²áÒªÄÄЩÌõ¼þ
- 60Ëê×¢²á¹«Ë¾Ìõ¼þÊÇʲô
- ÐÂÄÜÔ´ÓÐÏÞ¹«Ë¾×¢²áÐèҪʲôÌõ¼þ
- 60Ëê×¢²á¹«Ë¾Ìõ¼þÊÇÔõÑù
- ÈçºÎ¼ÆËã±±¾©×¢²á¹«Ë¾Ò¡ºÅµÄÖÐÇ©¼¸ÂÊ£¿Ïêϸ½éÉÜÖÐÇ©¹æÔòºÍ¼ÆËã·½·¨
- ¾Æµê¹ÜÀí¹«Ë¾×¢²áÌõ¼þ
- ±±¾©×¢²á¹«Ë¾Ë°ÊÕÄÜ·ñ¿çÊ¡½ÉÄÉ£¿¾ßÌå°ìÀíÁ÷³ÌÈçºÎ£¿
- ´ú°ì¹«Ë¾×¢²áµÄèÄå
- ±±¾©×¢²á¹«Ë¾ÊÇ·ñ¿ÉÒÔ¹º³µ£¿Ôõô°ìÀí£¿
- ¹«Ë¾ÈçºÎ×¢²á¶¤¶¤ÕË»§£¬¶¤¶¤Õ˺Å×¢²á²½ÖèÏê½â
- ¹ú×Êί¼à¹ÜµÄ¹úÓÐÆóÒµ¹«Ë¾×¢²á×ʽð±ä¸üÐèÒª×öÄÄÐ©ÌØÊâ´¦Àí£¿
- ¿ìÊÖ¹«Ë¾ºÅ×¢²á·ÑÓÃÊǶàÉÙ£¨Ïê½â¿ìÊÖ¹«Ë¾ºÅ×¢²áµÄ·ÑÓÃÇé¿ö£©
- ±¨¹Ø¹«Ë¾×¢²áÐèÒªÄÄЩÌõ¼þ
- ¹«Ë¾×¢²á¹É¶«ÄÜ¿¼¹«ÎñÔ±Âð
- ½¨É蹤³ÌÖн鹫˾ע²áÌõ¼þ