±±¾©Ê¯ÓÍ»¯¹¤Ñ§Ôº2026ÄêÑо¿ÉúÕÐÉú½ÓÊÕµ÷¼Á¹«¸æ
²é¿´: 9822  |  »Ø¸´: 220
¡¾½±Àø¡¿ ±¾Ìû±»ÆÀ¼Û204´Î£¬×÷Õßyjw100Ôö¼Ó½ð±Ò 160.8 ¸ö
µ±Ç°Ö»ÏÔʾÂú×ãÖ¸¶¨Ìõ¼þµÄ»ØÌû£¬µã»÷ÕâÀï²é¿´±¾»°ÌâµÄËùÓлØÌû

yjw100

гæ (СÓÐÃûÆø)


[×ÊÔ´] 2012Äê11ÔÂ×îÐÂÊé¼®---ÖÆÒ©¹¤ÒÕÑé֤ʵʩÊֲᣡ

ÖÆÒ©¹¤ÒÕÑé֤ʵʩÊÖ²á.pdf
Ö÷ ±à ºÎ¹úÇ¿
2012Äê11Ô±±¾©µÚ1 °æ
ÄÚÈÝÌáÒª
±¾Êé×÷Õ߸ù¾Ý¶àÄê´ÓÊÂÑéÖ¤µÄ¹¤×÷¾­Ñ飬±ü³Ð¡°Íƶ¯ÐÐÒµ½ø²½¡± µÄ·¢Õ¹ÀíÄÒÀ¾ÝÖйú¡¢ÃÀ¹ú¡¢Å·ÃË¡¢W H OµÈ¹ú¼ÒºÍ×éÖ¯µÄGM PºÍÒ©µäÒªÇ󣬲ο¼ICH¡¢ISO¡¢1SPE¡¢P 1C /SµÈÓйØ×ÊÁϱàд±¾Êé¡£ÄÚÈݺ­¸ÇÁËÖÆÒ©ÐÐÒµÖÐÔ­ÁÏÒ©¡¢¹ÌÌåÖÆ¼Á¡¢ÎÞ¾úÖÆ¼Á¡¢ÉúÎïÖÆÆ·¡¢ÑªÒºÖÆÆ·ºÍÖÐÒ©Éú²úµÄ¹¤ÒÕÉ豸¡¢¼ÆËã»ú»¯ÏµÍ³¡¢¹«ÓÃÉèÊ©¼°Ö§³ÖµÄ¸¨ÖúϵͳµÄÑéÖ¤¹¤×÷£»Í¬Ê±£¬»¹ðîÀ¨ÁË·çÏÕ¹ÜÀí¡¢ÊµÑéÊÒϵͳ¡¢Çå½àÑéÖ¤¼°¹¤ÒÕÑéÖ¤µÈ¹úÄÚÖÆÒ©ÐÐÒµÖØµã¹Ø×¢µÄÖ÷Ìâ¡£
±¾ÊéÊÊÓÃÓÚÏ£ÍûÁ˽âÖÆÒ©ÆóҵȷÈÏÓëÑéÖ¤¹¤×÷µÄרҵÈËÔ±£¬´ËÍâÎªÖÆÒ©ÆóÒµÌṩÉè¼Æ¡¢ÑéÖ¤×Éѯ·þÎñµÄÈËÔ±Ò²ÄÜ´Ó±¾
ÊéÖлñÈ¡µ½ÓмÛÖµµÄÐÅÏ¢¡£
·¶Î§
±¾ÊéÄÚÈݺ­¸ÇÁËÖÆÒ©ÐÐÒµÖÐÔ­ÁÏÒ©¡¢¿Ú·þ¹ÌÌåÖÆ¼Á¡¢ÎÞ¾úÖÆ¼Á¡¢ÉúÎïÖÆÆ·¡¢ÑªÒºÖÆÆ·ºÍÖÐÒ©Éú²úµÄ¹¤ÒÕÉ豸¡¢¼ÆËã»ú»¯ÏµÍ³¡¢¹«ÓÃÉèÊ©¼°Ö§³ÖµÄ¸¨ÖúϵͳµÄÑéÖ¤¹¤×÷£»±¾ÊéͬʱÄÒÀ¨ÁË·çÏÕ¹ÜÀí¡¢ÊµÑéÊÒϵͳ¡¢Çå½àÑéÖ¤¼°¹¤ÒÕÑéÖ¤µÈ¹úÄÚÖÆÒ©ÐÐÒµÖØµã¹Ø×¢µÄÖ÷Ìâ¡£
ÌØµã
ÒÔÏÂΪ±¾ÊéµÄÖØÒªÔ­Ôò£º
• Ç¿µ÷¡°ÖÊÁ¿Ô´ÓÚÉè¼Æ¡± (Quality by design, QbD)
• Ç¿µ÷¶Ô²úÆ·ºÍ¹¤ÒÕÐèÇóµÄÀí½â
• ²ÉÓûùÓÚ·çÏÕÆÀ¹ÀµÄ·½·¨
• ×ۺϹú¼ÊÏÖÐÐGM P·¨¹æ¶ÔÑéÖ¤µÄÒªÇó
• Ç¿µ÷²úÆ·±£»¤
• Ç¿µ÷¹Ø¼üÖÊÁ¿ÊôÐÔ(Critical quality attribute, CQA) ºÍ¹Ø¼ü¹¤ÒÕ²ÎÊý(Criticalprocess parameter, CPP) µÄÖØÒªÐÔ
• Á¼ºÃ¹¤³Ì¹ÜÀí¹æ·¶£¨Good engineering practice, GEP)
• Á¼ºÃÎļþ¹ÜÀí¹æ·¶£¨Good document practice, GDP)
• ¹á´©×îеÄÑéÖ¤°¸Àý·ÖÎö



ÍøÅÌÃâ·ÑÏÂÔØ£º
http://good.gd/2326900.htm
»Ø¸´´ËÂ¥

» ±¾Ìû¸½¼þ×ÊÔ´Áбí

  • »¶Ó­¼à¶½ºÍ·´À¡£ºÐ¡Ä¾³æ½öÌṩ½»Á÷ƽ̨£¬²»¶Ô¸ÃÄÚÈݸºÔð¡£
    ±¾ÄÚÈÝÓÉÓû§×ÔÖ÷·¢²¼£¬Èç¹ûÆäÄÚÈÝÉæ¼°µ½ÖªÊ¶²úȨÎÊÌ⣬ÆäÔðÈÎÔÚÓÚÓû§±¾ÈË£¬Èç¶Ô°æÈ¨ÓÐÒìÒ飬ÇëÁªÏµÓÊÏ䣺xiaomuchong@tal.com
  • ¸½¼þ 1 : ÖÆÒ©¹¤ÒÕÑé֤ʵʩÊÖ²á.pdf
  • 2012-11-29 17:32:13, 21.99 M

» ÊÕ¼±¾ÌûµÄÌÔÌûר¼­ÍƼö

¾­µä×ÊÔ´Ìû ÐÂÒ©Ñз¢±Ø±¸×ÊÁÏ Íò¾í¸óÖ®ËÑÉñ¼Ç ÁõÊÏÒ©Òµ
·ÂÖÆÒ©Ñз¢É걨 ¿Æ¼¼Ïà¹Ø ÁÙ´²Ò©Ñ§Ïà¹Ø Ò©¼ÁÉúѧϰ¿â
Ò©Æ·×¢²áºÍÒ©Æ·GMP ÖÆ¼ÁÊé¼® Ò©ÎïÖÆ¼ÁÑз¢ ¹¤×÷Óþß×ÊÁÏ
½ð¿â ÌÔ¾­µä ҩѧ¿ÆÑаٱ¦Ïä ×ÊÁÏÄã¿ìµ½ÎÒµÄÍëÀïÀ´
ҩѧ ÎáÖ®µÀ »¯Ò©×¢²áרÌù ÓÐÓö«¶«
ÐÄÁé¸ÛÍå ÐÂÒ©É걨

» ±¾ÌûÒÑ»ñµÃµÄºì»¨£¨×îÐÂ10¶ä£©

» ²ÂÄãϲ»¶

» ±¾Ö÷ÌâÏà¹Ø¼ÛÖµÌùÍÆ¼ö£¬¶ÔÄúͬÑùÓаïÖú:

ÒÑÔÄ   »Ø¸´´ËÂ¥   ¹Ø×¢TA ¸øTA·¢ÏûÏ¢ ËÍTAºì»¨ TAµÄ»ØÌû

merphi

½ð³æ (³õÈëÎÄ̳)


¡ï¡ï¡ï¡ï¡ï ÎåÐǼ¶,ÓÅÐãÍÆ¼ö

ºÜºÃµÄ×ÊÁÏ£¬ÖµµÃÊղأ¬Ð»Ð»
43Â¥2012-12-05 10:20:52
ÒÑÔÄ   »Ø¸´´ËÂ¥   ¹Ø×¢TA ¸øTA·¢ÏûÏ¢ ËÍTAºì»¨ TAµÄ»ØÌû
²é¿´È«²¿ 221 ¸ö»Ø´ð

yjw100

гæ (СÓÐÃûÆø)


×ÊÁϱȽϺ㬴ó¼Ò¶àÆÀÎåÐÇŶ¡£
2Â¥2012-11-29 17:36:57
ÒÑÔÄ   »Ø¸´´ËÂ¥   ¹Ø×¢TA ¸øTA·¢ÏûÏ¢ ËÍTAºì»¨ TAµÄ»ØÌû

ÄäÃû

Óû§×¢Ïú (ÕýʽдÊÖ)


±¾Ìû½öÂ¥Ö÷¿É¼û
11Â¥2012-11-30 10:26:00
ÒÑÔÄ   ÉêÇëPhEPI   »Ø¸´´ËÂ¥   ±à¼­   ²é¿´ÎÒµÄÖ÷Ò³
¼òµ¥»Ø¸´
dlshawei3Â¥
2012-11-29 19:19   »Ø¸´  
ÎåÐÇºÃÆÀ  ¶¥Ò»Ï£¬¸Ðл·ÖÏí£¡
pingshan4Â¥
2012-11-29 20:34   »Ø¸´  
ÎåÐÇºÃÆÀ  ¶¥Ò»Ï£¬¸Ðл·ÖÏí£¡
pch19676Â¥
2012-11-30 05:56   »Ø¸´  
ÎåÐÇºÃÆÀ  ¶¥Ò»Ï£¬¸Ðл·ÖÏí£¡
2012-11-30 06:54   »Ø¸´  
ÎåÐÇºÃÆÀ  ¶¥Ò»Ï£¬¸Ðл·ÖÏí£¡
caofahong8Â¥
2012-11-30 07:00   »Ø¸´  
ÎåÐÇºÃÆÀ  ¶¥Ò»Ï£¬¸Ðл·ÖÏí£¡
dingyechun10Â¥
2012-11-30 09:45   »Ø¸´  
ÎåÐÇºÃÆÀ  ¶¥Ò»Ï£¬¸Ðл·ÖÏí£¡
zhang30712Â¥
2012-11-30 10:44   »Ø¸´  
ÎåÐÇºÃÆÀ  ¶¥Ò»Ï£¬¸Ðл·ÖÏí£¡
2012-11-30 11:09   »Ø¸´  
ÎåÐÇºÃÆÀ  ¶¥Ò»Ï£¬¸Ðл·ÖÏí£¡
15294635114Â¥
2012-11-30 11:23   »Ø¸´  
ÎåÐÇºÃÆÀ  ¶¥Ò»Ï£¬¸Ðл·ÖÏí£¡
¡î ÎÞÐǼ¶ ¡ï Ò»ÐǼ¶ ¡ï¡ï¡ï ÈýÐǼ¶ ¡ï¡ï¡ï¡ï¡ï ÎåÐǼ¶
×î¾ßÈËÆøÈÈÌûÍÆ¼ö [²é¿´È«²¿] ×÷Õß »Ø/¿´ ×îºó·¢±í
[¿¼ÑÐ] Çóµ÷¼ÁÍÆ¼ö ²ÄÁÏ 304 +15 ºÉ°üµ°hyj 2026-03-26 15/750 2026-03-28 04:13 by fmesaito
[¿¼ÑÐ] 283Çóµ÷¼Á£¨080500£© +4 A child 2026-03-27 4/200 2026-03-27 15:34 by XPUÀîÇì
[¿¼ÑÐ] 274Çóµ÷¼Á +17 ¹Ë¾ÅóÏҪǫÐé 2026-03-24 23/1150 2026-03-27 15:16 by caszguilin
[¿¼ÑÐ] 0703Ò»Ö¾Ô¸9£¬³õÊԳɼ¨£º338£¬ËÄÁù¼¶Òѹý£¬ÓпÆÑо­Àú£¬Çóµ÷¼Á£¡ +3 Zuhui0306 2026-03-25 3/150 2026-03-27 14:09 by shangxh
[¿¼ÑÐ] 085600²ÄÁÏÓ뻯¹¤306 +10 z1z2z3879 2026-03-21 11/550 2026-03-27 11:31 by wangjy2002
[¿¼ÑÐ] 333Çóµ÷¼Á +3 questionÍì·ç 2026-03-23 3/150 2026-03-27 11:29 by ²»³Ôô~µÄ؈
[¿¼ÑÐ] ²ÄÁϵ÷¼Á 5+4 ÏëÒªÒ»ºøÌÒ»¨Ë® 2026-03-25 10/500 2026-03-26 19:56 by ²»³Ôô~µÄ؈
[¿¼ÑÐ] Öйú¿ÆÑ§ÔºÉîÛÚÏȽø¼¼ÊõÑо¿Ôº-¹âÏË´«¸Ð¿ÎÌâ×éÕÐÉú-Öйú¿ÆÑ§Ôº´óѧ¡¢ÉîÛÚÀí¹¤´óѧÁªÅà +5 YangTyu1 2026-03-26 5/250 2026-03-26 18:27 by èßäèßäѽ
[¿¼ÑÐ] 334·Ö Ò»Ö¾Ô¸ÎäÀí ²ÄÁÏÇóµ÷¼Á +4 ÀîÀî²»·þÊä 2026-03-26 4/200 2026-03-26 16:00 by ²»³Ôô~µÄ؈
[¿¼ÑÐ] 086000ÉúÎïÓëÒ½Ò©292Çóµ÷¼Á +6 СС³ÂСС 2026-03-22 9/450 2026-03-26 15:58 by dick_runner
[¿¼ÑÐ] ¿¼Ñе÷¼Á +6 À´ºÃÔËÀ´À´À´ 2026-03-21 7/350 2026-03-25 22:43 by 418490947
[¿¼ÑÐ] 334·Ö Ò»Ö¾Ô¸ÎäÀí-080500 ²ÄÁÏÇóµ÷¼Á +4 ÀîÀî²»·þÊä 2026-03-25 4/200 2026-03-25 21:26 by ÐÇ¿ÕÐÇÔÂ
[¿¼ÑÐ] 296Çóµ÷¼Á +4 Íô£¡£¿£¡ 2026-03-25 7/350 2026-03-25 16:41 by Íô£¡£¿£¡
[¿¼ÑÐ] ²ÄÁϵ÷¼Á +3 iwinso 2026-03-23 3/150 2026-03-25 11:29 by greychen00
[¿¼ÑÐ] 289²ÄÁÏÓ뻯¹¤£¨085600£©BÇøÇóµ÷¼Á +4 ÕâôÃû×ÖÕ¦Ñù 2026-03-22 5/250 2026-03-25 08:20 by mx.yue
[¿¼ÑÐ] 311Çóµ÷¼Á +3 ¶¬Ê®Èý 2026-03-24 3/150 2026-03-24 21:31 by peike
[¿¼ÑÐ] 0703»¯Ñ§µ÷¼Á£¬Çóµ¼Ê¦ÊÕ +7 ÌìÌìºÃÔËÀ´Éϰ¶° 2026-03-24 7/350 2026-03-24 20:26 by peike
[¿¼ÑÐ] 280·ÖÇóµ÷¼Á Ò»Ö¾Ô¸085802 +4 PUMPT 2026-03-22 7/350 2026-03-22 22:13 by ÐÇ¿ÕÐÇÔÂ
[¿¼ÑÐ] ÉúÎïѧµ÷¼Á +5 Surekei 2026-03-21 5/250 2026-03-22 14:39 by tcx007
[¿¼ÑÐ] Ò»Ö¾Ô¸±±¾©»¯¹¤´óѧ070300 ѧ˶336Çóµ÷¼Á +5 vvÃÔ 2026-03-21 8/400 2026-03-22 14:20 by ColorlessPI
ÐÅÏ¢Ìáʾ
ÇëÌî´¦ÀíÒâ¼û