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GMP Update & Technology Follow-up Vol. 20 ¿¹°í
2017-10-31
GMP Update & Technology Follow-upÀÌ À̹ø È£(Á¦20±Ç, °¡À»È£)·Î â°£ 10ÁÖ³âÀ» ¿Ï¼ºÇÑ´Ù. Ç¥Áö¸¦ È®Á¤Çϰí ÀÌÁ¦ Àμ⸦ À§ÇÑ ¸¶Áö¸· ±³Á¤ ÀÛ¾÷ ÁßÀÌ´Ù. °ð ±¸µ¶½ÅûÀ» Á¢¼öÇÒ °ÍÀ̸ç 11¿ù ¸¶Áö¸· ÁÖÂë ¹èÆ÷¸¦ ½ÃÀÛÇÒ ¿¹Á¤ÀÌ´Ù.** ±¸µ¶ ½Åû½Ã¿¡ ÁÖ¼Ò°Ë»öÀÌ µÇÁö ¾Ê´Â´Ù´Â ¹®Àǰ¡ ¸¹½À´Ï´Ù.°øÁö»çÇ׿¡ ÁÖ¼Ò°Ë»ö°ú °ü·ÃµÈ ³»¿ë(22¹ø ±Û)À¸·Î Çѹø ´õ ½ÃµµÇØ º¸½Ã°í, °è¼Ó ¿À·ù³ª °Ë»öÀÌ µÇÁö ¾ÊÀ» ½Ã....
GMP Update Vol. 19 ±¸µ¶½Åû ¸¶°¨
2017-09-01
¿À·§µ¿¾È °è¼ÓµÈ ±¸µ¶½ÅûÀ» ¸¶°¨ÇÏ¿´½À´Ï´Ù.Áö±ÝÂë ¸¶Áö¸· ¹èÆ÷ºÐ±îÁö ´Ù ¹ÞÀ¸¼ÌÀ» °ÍÀÔ´Ï´Ù. ¾ÆÁ÷ ¸ø ¹ÞÀ¸½Å ºÐÀÌ °è½Ã´Ù¸é Contact Us·Î ½Åû»óȲÀ» ¾Ë·ÁÁֽøé È®ÀÎÇÏ¿© ´Ù½Ã º¸³»µå¸®°Ú½À´Ï´Ù.ÀÌ ±âȸ¿¡ ȸ¿ø¿©·¯ºÐ²² ´çºÎµå¸®°í ½ÍÀº °ÍÀº sureGMP site¿¡ Àû¾îµµ ÇÑ ´Þ¿¡ ÇÑ ¹øÀº µé¸£¼Å¼ ±¸µ¶½Åû ÆË¾÷À» ¶ç¿ì¸é ¹Ù·Î ½ÅÃ»ÇØÁֽñ⠹ٶø´Ï´Ù. ÆË¾÷À» »çÀÌÆ® ù ȸ鿡 ¿À·¡ ¶ç¿ì´Â °ÍÀÌ º°·Î ÁÁ¾Æº¸ÀÌÁöµµ ¾ÊÀ» »Ó¸¸ ¾Æ´Ï¶ó ¿©·¯ ¹ø¿¡ ....
GMP Update Vol. 19 ¹èÆ÷ °³½Ã
2017-05-24
¾ÆÁ÷ ±¸µ¶½ÅûÀÌ ¸¶°¨µÈ °ÍÀº ¾Æ´ÏÁö¸¸ 22ÀÏ ½ÅûºÐ±îÁö ¹è¼Û ÀÛ¾÷ÀÌ ½ÃÀ۵Ǿú´Ù.±ÝÁÖ ¼ö¿ä, ¸ñ¿äÀϰæÀÌ¸é ¸ðµÎ ¹Þ¾Æº¸½Ç ¼ö ÀÖÀ» °ÍÀÌ´Ù.ÀÜ¿©ºÎ¼ö¿¡ ´ëÇÏ¿© ±¸µ¶½ÅûÀ» °è¼Ó ¹Þ°í ÀÖ´Ù. ¼ÒÁøµÈ ÀÌÈÄ¿¡ ¸ÞÀÏ·Î ÀÜ¿©ºÎ¼ö°¡ ÀÖ´À³Ä, ±¸¸ÅÇÒ ¼ö ÀÖ´À³Ä ¹®ÀÇÇϽô ºÐÀÌ °è½Åµ¥ ÀÌ ÀâÁö´Â Àü·® ¼ÒÁøµÉ 땨±îÁö ½Åû¹Þ¾Æ ¹èÆ÷ÇϹǷΠ¸¶°¨ ÀÌÈÄ´Â Àμ⺻À» º¸³¾ ¼ö°¡ ¾ø´Â °ÍÀÌ´Ù.
GMP Update Á¦19±Ç Ç¥Áö µðÀÚÀÎ È®Á¤
2017-04-18
GMP Update & Technology Follow-up Á¦19±Ç(2017³â º½È£)ÀÇ ÄÁÅÙÃ÷¸¦ È®Á¤ÇÏ°í ¶ÇÇÑ Ç¥Áö µðÀÚÀÎÀ» È®Á¤ÇÏ¿´´Ù.Áö±Ý Book DesignÁßÀÌ¸ç ¼öÀÏ ³»¿¡ ±¸µ¶½Åû ÆË¾÷À» ¿Ã¸± ¿¹Á¤ÀÌ´Ù. À̹ø ±¸µ¶½ÅûºÎÅÍ´Â ÀÔ±ÝÀ» ¸ÕÀú Çϰí ÀÔ±ÝÀÏÀÚ¸¦ Àû¾î¼ ½ÅûÇϵµ·Ï ÇÏ¿´´Ù. ÀϺΠ¹«½ÉÇϽŠºÐµéÀÌ (ÀǵµÀûÀº ºÐ¸í ¾Æ´Ò °ÍÀ̰í) Åùèºñ ÀÔ±ÝÀ» ±ôºýÇÏ´Â ÀÏÀÌ ³Ê¹« ¸¹¾Æ sureGMP·Î¼ ÃâÇ÷ÀÌ ¸¹¾Æ ºÎµæÀÌ ÃëÇÏ°ÔµÈ Á¶Ã³ÀÌ....
FDA-EMA MRAÇÕÀÇ: 2017³â 11¿ù ¹ßÈ¿
2017-04-05
2017³â 3¿ù 2ÀÏÀÚ·Î FDA¿Í EMA´Â Mutual Recognition Agreement(MRA)¿¡ ÇÕÀÇÇß´Ù°í ¹ßÇ¥Çß´Ù. ÀÌ·Î½á °¢ Á¦Á¶¾÷ü´Â ÇöÁöÀÇ ±ÔÁ¦±â°üÀÇ ½Ç»ç¸¸ ¹ÞÀ¸¸é µÇ°Ô µÇ¾ú´Ù. EU¿¡ ÀÖ´Â FDA inspector³ª ¹Ì±¹¿¡ ÀÖ´Â EU inspector´Â ¿¹¿ÜÀûÀÎ °æ¿ì¿¡¸¸ ½Ç»çÇÏ°Ô µÈ´Ù. ÀÌ MRA´Â 2017³â 11¿ùºÎÅÍ ¹ßÈ¿ÇÑ´Ù.
MHRA: Annex 16 QP certification and batch release FAQ part 1 ¹ßÇ¥
2017-02-24
MHRAÀÇ blog¿¡ Annex 16 QP certification and batch release °ü·Ã FAQ part 1ÀÌ ¿Ã¶ó ÀÖ´Ù. sureGMP°¡ Á¤¸®ÇÏ¿© ÀÚ·á½Ç¿¡ ¿Ã·Á ³õ¾Ò´Âµ¥ ±× ¸ñÂ÷´Â ´ÙÀ½°ú °°´Ù. (https://mhrainspectorate.blog.gov.uk/2017/02/23/annex-16-qp-certification-and-batch-release-frequently-asked-question....
ISPE: °íÇüÁ¦ Guide, Á¦¾à¿ë¼ö, ½ºÆÀ ¹× °¡½º °ËüäÃë¿¡ °üÇÑ Guide ¹ßÇà
2017-01-05
ISPE°¡ Áö³ ÇØ 11¿ù Baseline Guide: Oral Solid Dosage Forms 3°³Á¤(240 pages)¿¡ À̾î 12¿ù¿¡´Â Good Practice Guide: Sampling for Pharmaceutical Water, Steam, and Process Gases(122 pages)¸¦ ¹ßÇàÇÏ¿© ¹ß¸Å ÁßÀÌ´Ù.
½Ä¾àó: ÀÇ·á±â±â Á¦Á¶ ¹× ǰÁú°ü¸® ±âÁØ(Á¦2016-156È£) ¹ßÈ¿
2017-01-04
ÀÇ·á±â±â Á¦Á¶ ¹× ǰÁú°ü¸® ±âÁØ(½Ä¾àó °í½Ã Á¦2016-156È£)ÀÌ 2016³â 12¿ù 30ÀϺÎÅÍ ½ÃÇàµÈ´Ù. ¿ø¹®Àº http://www.mfds.go.kr/index.do?mid=687&pageNo=1&seq=11508&sitecode=2016-12-30&cmd=v ¿¡¼ ³»·Á ¹ÞÀ» ¼ö ÀÖ´Ù.
½Ä¾àó: ÀǾàǰ µîÀÇ ¾ÈÀü¿¡ °üÇÑ ±ÔÄ¢(ÃѸ®·É Á¦1298È£ ÀϺΰ³Á¤) ¹ßÈ¿
2017-01-04
2016.6.30. ÃѸ®·É Á¦1298È£·Î ÀϺΠ°³Á¤ÇÑ ¡°ÀǾàǰ µîÀÇ ¾ÈÀü¿¡ °üÇÑ ±ÔÄ¢¡±ÀÌ °í½ÃÇÑ ´ë·Î 2016.12.30ºÎÅÍ ½ÃÇàµÈ´Ù. ¿ø¹®Àº ±¹°¡¹ý·É¼¼ÅÍ(http://law.go.kr/lsSc.do?menuId=0&p1=&subMenu=1&nwYn=1¡×ion=&tabNo=&query=%EC%9D%98%EC%95%BD%ED%92%88%20%EB%93%B1%....
MHRA: 2017 ³â ÆÇ Orange Guide Ãâ°£
2016-12-03
2017 ³â ÆÇ(10°³Á¤) Rules and Guidance for Pharmaceutical Manufacturers and Distributors(Orange Guide)°¡ °ð Ãâ°£µÈ´Ù. Áß¿ä ³»¿ëÀº ´ÙÀ½°ú °°´Ù.qualification of suppliers and customers;parallel importation and parallel distribution;temperature control and mon....
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