ºÃÎĵµ - רҵÎÄÊéд×÷·¶ÎÄ·þÎñ×ÊÁÏ·ÖÏíÍøÕ¾

Ò©³§·ÏË®´¦ÀíÏîÄ¿¿ÉÐÐÐÔ±¨¸æ-D

ÓÉ ÌìÏ ·ÖÏí ʱ¼ä£º ¼ÓÈëÊÕ²Ø ÎÒҪͶ¸å µãÔÞ

Ò©³§·ÏË®´¦ÀíÏîÄ¿¿ÉÐÐÐÔ±¨¸æ

Ò©³§·ÏË®´¦ÀíÏîÄ¿¿ÉÐÐÐÔ±¨¸æ

Ç° ÑÔ

ijijҩҵÓÐÏÞÔðÈι«Ë¾Î»ÓÚ¶«±±ÖØÒªÊàŦ³ÇÊÐijij£¬ÊÇijijʡ´óÐÍÒ½Ò©¼Ó¹¤ÆóÒµ£¬Ò©Æ·µÄСÈÝÁ¿×¢ÉäÒº¡¢¿Ú·þÒº¡¢¹ÌÌåÖƼÁºÍÔ­ÁÏÒ©¾ùÒÑͨ¹ý¹ú ¼Ò GMP ÈÏÖ¤¡£¹ÌÌåÖƼÁ¡¢Ð¡ÈÝÁ¿×¢Éä¼ÁµÈ²úÆ·¹©²»Ó¦Çó£¬ÔÚ¹úÄÚÍâÊг¡ÏíÓÐÊ¢Óþ¡£

ijijҩҵÓÐÏÞÔðÈι«Ë¾ÒÑÓÚ

2002 Ä꽨ÔìÒ»Ì×ÎÛË®´¦ÀíÉèÊ©²¢Í¶ÈëÔË

ÐУ¬ÓÃÒÔ´¦ÀíÆóÒµÔÚÉú²ú¹ý³ÌÖÐÅųöµÄ·ÏË®¡£¹«Ë¾Ê®·ÖÖØÊÓ»·¾³µÄÕûÌåЧ Ó¦£¬ÓÉÓÚÏÖÓÐÎÛË®´¦ÀíÕ¾µÄλÖò»ÊʺÏÔÚÉú²úÇøÄÚ£¨

GMP ÒªÇ󣩣¬¼ÓÖ®Ô­

É豸³Â¾ÉÒ²Ðè¸ÄÔ죬Äâ¶ÔÏÖÓеÄÎÛË®´¦ÀíÉèÊ©½øÐÐǨÒÆÉý¼¶¸ÄÔ졣Ŀ Ç°¹«Ë¾ÒѾ­°Ñ·ÏË®ÖÎÀí¹¤³ÌÏîÄ¿ÁÐΪ½üÆÚµÄÖØ´ó»ù½¨ÏîÄ¿£¬ÄÉÈ빫˾½¨Éè ¼Æ»®¡£¸Ã¹¤³Ìʵʩºó£¬½«½øÒ»²½¼õÇáË®ÌåÎÛȾ£¬Îª¼ÓÇ¿Ë®ÎÛȾ·ÀÖκÍË®»·¾³±£»¤£¬ÊµÊ©Ë®×ÊÔ´¿É³ÖÐøÀûÓÃ×ö³ö¹±Ï×£¬·ûºÏ¿É³ÖÐø·¢Õ¹ÀíÄîµÄ¾­¼ÃÔö³¤Ä£Ê½£¬Òò´Ë¸Ã¹¤³ÌÓÐÃ÷ÏԵĻ·¾³Ð§Òæ¡¢Éç»áЧÒæ¡£Ôڴ˱³¾°Ï£¬ÎÒ¹«Ë¾ÊÜijijҩҵÓÐÏÞÔðÈι«Ë¾µÄίÍУ¬ÒÀ¾Ý¸Ã¹«Ë¾×ÜÌå¹æ»®±àÖƸ÷ÏË®ÖÎÀí¹¤³ÌÏîÄ¿¿ÉÐÐÐÔÑо¿±¨¸æ¡£Îª´Ë£¬¹«Ë¾Éè¼ÆÈËÔ±ºÍ¶à¶àÒ©ÒµÓÐÏÞÔðÈι«Ë¾ÓйØÈËÔ±£¬¾­¹ý¶à´ÎÏÖ³¡Ì¤¿±¡¢ËѼ¯´óÁ¿µÄ»ù´¡×ÊÁÏ£¬ÔÚÓйز¿ÃŵİïÖú Ï£¬¶Ô³§ÇøµÄµØÐΡ¢¸øË®¡¢ÅÅË®ÏÖ×´½øÐÐÁËÉîÈëϸÖµĵ÷²éÑо¿ºÍÈÏÕæµÄ×ۺϷÖÎö¡£ÔÚ´Ë»ù´¡ÉÏÍê³ÉÁ˶à¶àÒ©ÒµÓÐÏÞÔðÈι«Ë¾·ÏË®ÖÎÀí¹¤³ÌÏîÄ¿¿ÉÐÐÐÔÑо¿±¨¸æµÄ±àÖƹ¤×÷¡£

Ò©³§·ÏË®´¦ÀíÏîÄ¿¿ÉÐÐÐÔ±¨¸æ

Ŀ ¼

1. ¸Å Êö ........................................................... 1

1.1 ÏîÄ¿¸Å¿ö ...................................................... 1 1.1.1 ÏîÄ¿Ãû³Æ .................................................. 1 1.1.2 ÏîÄ¿½¨É赥λ ............................................. 1 1.1.3 ½¨ÉèµØµã .................................................. 1 1.1.4 ±àÖƵ¥Î» .................................................. 1 1.2 ¿ÉÐÐÐÔÑо¿±¨¸æ±àÖÆÒÀ¾Ý¡¢Ô­Ôò¼°·¶Î§ ........................... 1 1.2.1 ±àÖÆÒÀ¾Ý .................................................. 1 1.2.2 ±àÖÆÔ­Ôò .................................................. 3 1.2.3 ±àÖÆ·¶Î§ .................................................. 4 1.3 ÏîÄ¿½¨ÉèÌõ¼þ .................................................. 4 1.3.1 µØÀíλÖà .................................................. 4 1.3.2 µØÖÊ¡¢µØò ............................................... 4 1.3.3 ÆøÏó¡¢Æøºò ............................................... 4 1.3.4 ˮԴ¡¢¹©ÅÅË®¡¢ÅÅÀԺͷÀºéÇé¿ö ............................. 5 1.3.5 µçÔ´¡¢¹©µçÇé¿ö ........................................... 5 1.3.6 ¹©ÈÈÇé¿ö .................................................. 5 1.4 Ö÷Òª¼¼Êõ¾­¼ÃÖ¸±ê ............................................. 6 1.5 ¹«Ë¾¸Å¿ö ...................................................... 6 1.5.1 ¹«Ë¾×ÔÈ»×´¿ö ............................................. 6 1.5.2 ¹«Ë¾Ö÷Òª²úÆ·¼°Éú²ú¹æÄ£ ................................... 7 1.5.3 Éú²ú¼¼Êõ×°±¸ ............................................. 7

Ò©³§·ÏË®´¦ÀíÏîÄ¿¿ÉÐÐÐÔ±¨¸æ

1.6.1 ÎÒ¹úË®ÎÛȾºÍÎÛË®´¦ÀíÏÖ×´µÄÑϾþÏÖʵ ....................... 7 1.6.2 ±¾ÏîÄ¿½¨ÉèµÄ±ØÒªÐÔ ....................................... 8 1.7 ¹¤³Ì½¨ÉèµÄ¿ÉÐÐÐÔ ............................................. 9

2. ÏîÄ¿½¨ÉèÄÚÈݼ°¹æÄ£ .............................................. 10

2.1 ÏîÄ¿½¨ÉèÄÚÈÝ ...................................................................................1 0. 2.1.1 ·ÏË®´¦ÀíÕ¾ ................................................................................1 0.

3. ¼¼Êõ·½°¸È·¶¨ .................................................... 11

3.1 ·ÏË®´¦ÀíÕ¾Éè¼Æ´¦ÀíË®Á¿¼°·ÏˮˮÖÊÈ·¶¨ ...................... 11 3.1.1 Éè¼ÆË®Á¿ ......................................................................................1 1 3.1.2 Éè¼ÆË®ÖÊ ......................................................................................1 1 3.2 ·ÏË®´¦Àí¹¤ÒÕµÄÈ·¶¨ ........................................................................1 2 3.2.1 ¹¤ÒÕÁ÷³ÌÈ·¶¨µÄÔ­Ôò .................................................................1 2 3.2.2 ÎÛË®ÖÐÎÛȾÎïÈ¥³ý¼¼ÊõÑо¿¼°±È½Ï ...................... 1. 3 3.2.3 ·ÏË®´¦Àí¹¤ÒÕ ..............................................................................1 6 3.2.4 È¥³ýЧÂÊÔ¤²â ..............................................................................1 8 3.3 ÎÛÄà´¦Àíϵͳ×ÛÊö ............................................................................1 8 3.4 ³ôÆø´¦Àíϵͳ×ÛÊö ............................................................................1 8 3.5 ÔÚÏß¼ì²â¼°ÏµÍ³¿ØÖÆ×ÛÊö ................................................................1 9 3.6 ·ÏË®×ۺϴ¦Àí³§³§Ö·Ñ¡Ôñ ................................................................2 0

4. ¹¤³ÌÉè¼Æ ........................................................ 21

4.1 ³§ÇøƽÃæÉè¼Æ ...................................................................................2 1. 4.1.1 ƽÃæ²¼ÖõÄÔ­Ôò ..........................................................................2 1 4.1.2 Õ¼µØÃæ»ý ......................................................................................2 1

Ò©³§·ÏË®´¦ÀíÏîÄ¿¿ÉÐÐÐÔ±¨¸æ

4.1.3 ƽÃæλÖà .............................................. 2..1 4.2 µ¥ÔªÉè¼Æ ...........................................................................................2 1. 4.2.1 ¸ñÕ¤¾®.........................................................................................2 2. 4.2.2 µ÷½Ú³Ø.........................................................................................2 2. 4.2.3 ʹʳØ.........................................................................................2 3. 4.2.4 ¼Óҩϵͳ ......................................................................................2 4 4.2.5 ×éºÏÆø¸¡ ....................................................................................2 5. 4.2.6 ͶÅä³Ø.........................................................................................2 5. 4.2.7 Ò»¼¶ UASB ³Ø.............................................................................2 6 4.2.8 ¶þ¼¶ UASB ³Ø.............................................................................2 6 4.2.9 ÑáÑõ³Áµí³Ø ..................................................................................2 7 4.2.10 Ò»¼¶½Ó´¥Ñõ»¯³Ø .......................................................................2 7 4.2.11 ¶þ¼¶½Ó´¥Ñõ»¯³Ø .......................................................................2 7 4.2.12 ¶þ³Á³Ø.......................................................................................2 8. 4.2.13 »ìÄý³Áµí³Ø ................................................................................2 9 4.2.14 ÖмäË®³Ø ........................................... 2.9. 4.3.15 É°Â˹Þ.......................................................................................2 9. 4.2.16 ÇåË®³Ø.......................................................................................3 0. 4.2.17 ÎÛÄà´¢³Ø ........................................... 3.0. 4.2.18 ÎÛÄàŨËõ³Ø ................................................................................3 1 4.2.19 ³ôÆø´¦Àíµ¥ÔªÉ豸 ....................................................................3 1 4.2.20 ×ÛºÏÉ豸¼ä ................................................................................3 2 4.2.21 ·ç»ú·¿.......................................................................................3 3. 4.2.22 ÐÝÏ¢¡¢¿ØÖÆ¡¢»¯ÑéÊÒ ...............................................................3 3

Ò©³§·ÏË®´¦ÀíÏîÄ¿¿ÉÐÐÐÔ±¨¸æ-D

Ò©³§·ÏË®´¦ÀíÏîÄ¿¿ÉÐÐÐÔ±¨¸æÒ©³§·ÏË®´¦ÀíÏîÄ¿¿ÉÐÐÐÔ±¨¸æÇ°ÑÔijijҩҵÓÐÏÞÔðÈι«Ë¾Î»ÓÚ¶«±±ÖØÒªÊàŦ³ÇÊÐijij£¬ÊÇijijʡ´óÐÍÒ½Ò©¼Ó¹¤ÆóÒµ£¬Ò©Æ·µÄСÈÝÁ¿×¢ÉäÒº¡¢¿Ú·þÒº¡¢¹ÌÌåÖƼÁºÍÔ­ÁÏÒ©¾ùÒÑͨ¹ý¹ú¼ÒGMPÈÏÖ¤¡£¹ÌÌåÖƼÁ¡¢Ð¡ÈÝÁ¿×¢Éä¼ÁµÈ²úÆ·¹©²»Ó¦Çó£¬ÔÚ¹úÄÚÍâÊг¡ÏíÓÐÊ¢Óþ¡£
ÍƼö¶È£º
µã»÷ÏÂÔØÎĵµÎĵµÎªdoc¸ñʽ
5pcb247wuk55t2h95x553fre38hi550117f
ÁìÈ¡¸£Àû

΢ÐÅɨÂëÁìÈ¡¸£Àû

΢ÐÅɨÂë·ÖÏí