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½Ä¾àó: ÀǾàÇ° Çã°¡,½É»çºÐ¾ß ÀÚÁÖ¹¯´Â ÁúÀÇÀÀ´äÁý ¹ß°£ 2015-07-29
½Ä¾àó ÀǾàÇ°½É»çºÎ¿¡¼­´Â 2010³â ÀÌÈÄÀÇ ÁÖ¿äÇÑ Çã°¡½É»ç °ü·Ã ÁúÀÇȸ½Å Áß ºó¹øÇÑ ÁúÀǴ亯 »ç·Ê¸¦ Á¤¸®ÇÏ¿© ÀǾàÇ° °³¹ß ½Ã ¹ß»ýµÇ´Â ±Ã±ÝÁõÀ» ÇØ°áÇÏ°í, ½É»çÀÚ ¹× °³¹ßÀÚ°¡ ¹Î¿ø»ó´ã ³»¿ëÀ» ¼­·Î °øÀ¯ÇÒ ¼ö ÀÖµµ·Ï ¡®ÀǾàÇ° Çã°¡∙½É»çºÐ¾ß ÀÚÁÖ ¹¯´Â ÁúÀÇÀÀ´äÁý(2010³â~2015³â 6¿ù)¡¯À» ¹ß°£ÇÏ¿© ȨÆäÀÌÁö¿¡ °Ô½ÃÇÏ¿´´Ù.¡Û ÁÖ¿ä ³»¿ë- 1ºÎ : 2010³â~2014³â ÁúÀÇ È¸½Å ³»¿ë Áß ±âÃÊÀûÀÌ°í ºó¹øÇÑ ÁúÀÇȸ½Å »çÇ× - 2ºÎ ....
EDQM-À¯·´¾àÀü °³Á¤(¾È): RO¿¡ ÀÇÇÑ ¹° WFI·Î ÀÎÁ¤ 2015-05-01
4¿ù 15ÀÏ EDQM ´º½º¿¡ ÀÇÇÏ¸é ±× µ¿¾È ³íÀÇ µÇ¾î¿À´ø Water for Injections °¢Á¶¿¡ ´ëÇÑ  °³Á¤ÀÌ °á·ÐÀ» ³»°í °³Á¤ÃʾÈÀ» ¹ßÇ¥ÇÏ¿´´Ù. Áï Áõ·ù ÀÌ¿ÜÀÇ ¹æ¹ýÀ¸·Î Á¦Á¶ÇÑ ¹°À» ÁÖ»ç¿ëÀ¸·Î »ç¿ëÇÒ ¼ö ÀÖµµ·Ï ÇÑ´Ù´Â °ÍÀÌ´Ù.°³Á¤ ºÎºÐÀ» ¿Å°Ü ÀûÀ¸¸é ´ÙÀ½°ú °°´Ù.WFI is produced either by [..destillation, . ].orby reverse osmosis, which may be single....
EU GMP Annex 15. Qulaification and Validation °³Á¤ 2015-04-06
EMA´Â Áö³­ 3¿ù 30ÀÏ, EU GMP Annex 15 Qualification and Validation °³Á¤ÆÇÀ» È®Á¤ ¹ßÇ¥ÇÏ°í 10¿ù 1ÀϺÎÅÍ ¹ßÈ¿ÇÑ´Ù°í ÇÏ¿´´Ù.16ÆäÀÌÁö·Î ±¸¼ºµÈ °³Á¤ÆÇÀÇ Áß¿ä ³»¿ëÀ» ¿ä¾àÇÏ¸é ´ÙÀ½°ú °°´Ù.»õ·Î¿î Annex 15´Â ¿ø·á¾àÇ°¿¡µµ Àû¿ëÇÑ´Ù.Life cycle°³³äÀÌ µµÀԵǾú´Ù.ȸ°íÀû ¹ë¸®µ¥À̼ÇÀÌ Á¦¿ÜµÇ¾ú´Ù.Validation Master Plan- VMPÀÇ ³»¿ë È®Àå; Deviation manageme....
EMA: EU GMP Guide, Annex 1 °³Á¤¿¡ °üÇÑ Concept Paper ¹ßÇà 2015-02-21
EMA´Â ÀÌ´Þ µé¾î EU GMP Guide, Annex 1 °³Á¤¿¡ °üÇÑ Concept Paper¸¦ ¹ßÇàÇÏ°í ÀÇ°ßÀ» ûÃëÇÏ°í ÀÖ´Ù. 2007³â ÀÌ guidelineÀÌ ¹ßÇ¥µÈ ÀÌÈÄ ¹ßÀüµÈ ±â¼úÀ» µµÀÔÇÏ°í ICH Q9 ¿Í Q10¸¦ ¹Ý¿µÇÏ´Â µ¿½Ã¿¡ ¿À·ù¸¦ ¹Ù·ÎÀâ°í ¸ðÈ£ÇÑ Ç¥ÇöÀ» ºÐ¸íÈ÷ ÇÏ°Ú´Ù´Â ÃëÁöÀÌ´Ù. ¶Ç Áõ·ù¿¡ ÀÇÇÑ ÁÖ»ç¿ë¼ö¸¸ Çã¿ëÇÏ´ø À¯·´ ¾àÀüÀÌ ¹Ù²î¸é À̸¦ ¹Ý¿µÇÏ°Ú´Ù´Â ¾ð±Þµµ ÀÖ´Ù. ¶Ç ÀÌÁ¦±îÁö ÀÌ g....
½Ä¾àó•PIC/S•PDA °øµ¿ÁÖÃÖ ±³À°: GMP for APIs (ICH Q7) 2014-12-23
½Ä¾àó•PIC/S•PDA °øµ¿ÁÖÃÖ ÈƷðúÁ¤ ¹× PDA ÁÖÃÖ ¿öÅ©¼ó, ¼­¿ï¿¡¼­ µ¿½Ã °³ÃÖ½ÄÇ°ÀǾàÇ°¾ÈÀüó, PIC/S ¹× PDA EuropeÀÌ °øµ¿À¸·Î ÁÖÃÖÇÏ´Â Training Course¿Í PDA ´Üµ¶À¸·Î ÁÖÃÖÇÏ´Â Workshop(µ¿½ÃÅ뿪ÇÔ)ÀÌ ´ÙÀ½°ú °°ÀÌ µ¿½Ã¿¡ °³ÃֵȴÙ. ¢Ñ ³¯Â¥: 2015³â 1¿ù 22~23ÀÏ(¸ñ~±Ý)¢Ñ Àå¼Ò: Courtyard by Marriot Seoul Times Square (¿µµîÆ÷±¸ ¼ÒÀç....
½Ä¾àó: ´ëÇѹα¹ ¾àÀü 11°³Á¤ 2014-12-06
´ÙÀ½Àº ½Ä¾àóÀÇ ´ëÇѹα¹ ÀüºÎ°³Á¤°í½Ã(½ÄÇ°ÀǾàÇ°¾ÈÀüó °í½Ã Á¦2014-194È£)Àü¹®ÀÌ´Ù.´ëÇѹα¹¾àÀü ÀüºÎ°³Á¤°í½Ã1. °³Á¤ ÀÌÀ¯ ÀǾàÇ°ÀÇ ÀûÁ¤ÇÑ Ç°Áú°ü¸®¿Í »õ·Î¿î Á¦Çü°³¹ß È°¼ºÈ­¸¦ À§ÇÏ¿© Åõ¿©°æ·Î¡¤Àû¿ëºÎÀ§¸¦ ±âÁØÀ¸·Î ÀǾàÇ° Á¦ÇüÀÇ ºÐ·ù¸¦ ¼¼ºÐÈ­ÇÏ°í »õ·Î¿î Á¦ÇüÀ» ½Å¼³ÇÏ¸ç ½ÃÇèÀÚ ¾ÈÀü°ú ȯ°æº¸È£¸¦ À§ÇÏ¿© À¯ÇؽþàÀ» ´ëüÇÏ´Â ½ÃÇè¹ýÀ» Ãß°¡ÇÏ´Â ÇÑÆí, ÀǾàÇ° ±Ô°Ý±âÁØÀ» ±¹Á¦±âÁØ¿¡ µû¶ó ¡¸´ëÇѹα¹¾àÀü¡¹À» Áß½ÉÀ¸·Î ÅëÇÕ¡¤ÀÏ¿øÈ­ÇÏ¿© Á¦Á¶̶....
Croatia HALMED: PIC/S ȸ¿ø°¡ÀÔ ½Åû 2014-11-15
Áö³­ 9¿ù 5ÀÏ Croatia HALMED*°¡ PIC/S ȸ¿ø°¡ÀÔÀ» ½ÅûÇÏ¿´´Ù. *Agency for Medicinal Products and Medical Devices)
GMP Update & Technology Follow-up 2014³â °¡À»È£ ¹ßÇà ¿¹°í 2014-10-20
GMP Update & Technology Follow-up 2014³â °¡À»È£°¡ Â÷Áú ¾øÀÌ ÁغñµÇ°í ÀÖ´Ù.11¿ù ¸¶Áö¸· ÁÖ¿¡ ¹ßÇàµÉ ¿¹Á¤ÀÌ´Ù. À̹ø È£´Â ÄÁÅÙÃ÷°¡ ƯÈ÷ dzºÎÇÏ´Ù. ¿ì¼± Part I¿¡´Â ÃֽŠ°³Á¤µÈ EU GMP Chapter 3, 5, 6, 8ÀÇ ¿µÇÑ ´ë¿ªÆÇÀÌ ½Ç¸°´Ù. ´Ù¸¸ Chapter6Àº Áö³­ È£¿¡¼­ È®Á¤ Á÷ÀüÀÇ ³»¿ëÀ» ½Ç¾ú¾ú´Âµ¥ À̹ø¿¡ È®Á¤µÈ °ÍÀ» ´Ù½Ã ½Æ´Â °ÍÀÌ´Ù. Part II¿¡´Â GMP....
´ëÇѹα¹: PIC/S °¡ÀÔ (2014³â 7¿ù 1ÀϺÎÅÍ È¸¿ø ÀÚ°Ý) 2014-05-20
 ¾îÁ¦(5¿ù 19ÀÏ) PIC/S News¿¡ ÀÇÇϸé 5¿ù 15~16ÀÏ ·Î¸¶¿¡¼­ ¿­¸° PIC/S Committee¿¡¼­ ÀϺ»°ú Çѱ¹ÀÌ 7¿ù 1ÀÏÀÚ·Î PIC/Sȸ¿øÀ¸·Î ½ÂÀÎ, ÃÊ´ëµÇ¾ú´Ù. ±â»ç ¿ø¹®Àº ¾Æ·¡¿Í °°´Ù.Japan and Korea to join PIC/S    Geneva (Switzerland), 19 May 2014: The PIC/S Committee, meeting in Rome (Ital....
GMP Update Á¦13±Ç : 5¿ù ¹ßÇà ¹èÆ÷ 2014-04-24
µåµð¾î GMP Update Á¦13±ÇÀÇ ÄÁÅÙÃ÷¸¦ È®Á¤ÇÏ°í 5¿ù 20ÀÏ ¹ßÇà, ¹èÆ÷¸¦ ¸ñÇ¥·Î Â÷Áú¾øÀÌ ÁøÇàµÇ°í ÀÖ´Ù. °ð ±¸µ¶½Åû Æ˾÷À» ¿Ã¸± ¿¹Á¤ÀÌ´Ù.   ÀÌ ¹ø º½È£ÀÇ Áß¿ä ³»¿ëÀº ´ÙÀ½°ú °°´Ù. Á¦1ºÎ GMP Update Guideline on Process Validation for finished products (EMA) Q&A on Quality Spa....
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