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GMP °ü·Ã¸µÅ©
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Áß±¹ CFDA: ¹«±ÕÀǾàǰ GMP 2014³âºÎÅÍ Àû¿ë
2014-01-24
Áö³ ÇØ 12¿ù 31ÀÏ Áß±¹ ±¹°¡½Äǰ¾àǰ°¨µ¶°ü¸®Ãѱ¹(China Food and Drug Administration: CFDA)Àº ¹«±ÕÀǾàǰ¿¡ ´ëÇÏ¿© 2010³â °³Á¤ÇÑ »õ·Î¿î GMP¸¦ Àû¿ëÇÑ´Ù°í °øÇ¥ÇÏ¿´´Ù.»õ·Î¿î GMPÀÇ Àû¿ë°ú °ü·ÃÇÏ¿© Ç÷¾×Á¦Á¦, ¹é½Å, ÁÖ»çÁ¦ ¹× ±âŸ ¹«±ÕÀǾàǰÀº 2013³â 12¿ù 31ÀÏÀÌÀü¿¡ »õ·Î¿î GMP¸¦ ÁؼöÇØ¾ß ÇÑ´Ù°í °øÇ¥ÇÑ ¹Ù ÀÖ´Ù. º¸µµÀÚ·á: http://eng.sfda.gov.cn/WS03/CL0757/....
Àεµ GMP: WHO GMP¿¡ ¸ÂÃá´Ù
2014-01-16
1¿ù 8ÀÏÀÚ pharmabiz.com ¿¡ µû¸£¸é Àεµ Á¤ºÎ´Â WHO GMP¿¡ ¸ÂÃç ÀεµGMP¸¦ °³Á¤ÇÒ °èȹÀ̶ó°í ÇÑ´Ù. The Drugs Controller General of India (DCGI) ´Â Global standard¿Í Á¶ÈÇϱâ À§ÇØ °¢°è Àü¹®°¡ÀÇ ÀǰßÀ» ±¸Çϰí ÀÖ´Ù. ÇÑÆí ¾÷°è´Â Schedule MÀ» WHO-GMP¿Í Á¶ÈÇÏ¿© Schedule M¿¡ µû¸¥ GMP certificate°ú ÀÏÄ¡ÇÏ°Ô ÇØÁÙ °ÍÀ» ¿äûÇϰí ÀÖ´Ù. ....
EMA: EudraGMDP¿¡ GMPºÎÀûÇÕº¸°í¼ °ø°³ÇÑ´Ù
2014-01-10
¹Ì FDA°¡ GMP ºÎÀûÇÕ »ç·Ê¸¦ Form 483 ³ªWarning Letters Çü½ÄÀ¸·Î °ø°³ÇÏ¿© ¿À°í ÀÖÀ¸³ª EU´Â ÀÌÁ¦±îÁö inspection°á°ú¸¦ ¾î¶² ÇüÅÂ·Îµç °ø°³ÇÑ ¹Ù ¾ø¾ú´Ù.European Medicines Agency (EMA)´Â ¿ÃÇØºÎÅÍ EudraGMDP database ¸¦ »õ·Ó°Ô Çϰí GMP ºÎÀûÇÕ »ç·Ê¸¦ ¹ßÇ¥Çϱ⠽ÃÀÛÇß´Ù. ±ÔÁ¦±â°üµéÀº Á¦Á¶ÇöÀåÀ» inspectionÇϰí GMP¿¡ Ãæ½ÇÇÏ´Ù°í °á·ÐÀÌ....
¹Ì-Áß±¹ GMP Inspection °È ÇÕÀÇ
2013-12-19
¹Ì±¹ FDA´Â Heparin »ç°Ç ÀÌÈÄ Áß±¹°ú ÀεµÀÇ Æ¯È÷ APIÁ¦Á¶¾÷ü¿¡ ´ëÇÑ GMP InspectionÀ» °ÈÇØ ³ª°¡°í ÀÖ´Ù. ÀÌ¹Ì 2008³â 11¿ù Áß±¹¿¡ FDA»ç¹«½ÇÀ» °³¼³Çϱ⠽ÃÀÛÇÏ¸é¼ °·ÂÇÑ ÀÇÁö¸¦ º¸À̰í ÀÖÁö¸¸ Áß±¹Á¤ºÎ´Â FDA Inspector¿¡ ´ëÇÑ ºñÀÚ ¹ß±ÞÀ» ±â¾à¾øÀÌ Áö¿¬½ÃŰ´Â µî Àå¾Ö¿¡ ºÎµúÇô ±× ÃßÁø ½ÇÀûÀº ¸¸Á·½º·´Áö ¸øÇÏ¿´´Ù. 2013³â 12¿ù 5ÀÏ White House º¸µµÀÚ·á(htt....
PIC/S °¡ÀÔ½Åû ÁøÇà»óȲ
2013-11-21
Áö³ 10¿ù 7~11ÀÏ Ottawa, Canada¿¡¼ ¿¸° PIC/S Meetings¿¡ ´ëÇÑ º¸µµÀÚ·á(2013.11.4.)¿¡ ÀÇÇϸé PIC/S°¡ÀÔ ½ÅûÀÚ¿¡ ´ëÇÑ Æò°¡ ÁøÇà»óȲÀº ´ÙÀ½°ú °°´Ù. Brazil/ANVISA: ¼·ù ½É»ç ³»³â¿¡ °³½ÃÇÒ ¿¹Á¤ ÀϺ»/MHLW &PMDA&Prefectures: 9¿ù 9~13ÀÏ on-site inspectionÀÇ ¼º°øÀûÀÎ °á°ú¿Í °ü·ÃÇÏ¿© ±¸µÎ º¸°í ´ëÇѹα¹/MFDS: ¼·ù½É»çº¸°í....
Hong Kong SAR : PIC/S °¡ÀÔ½Åû
2013-10-28
PIC/S¿¡ µû¸£¸é Áö³ 8¿ù 30ÀÏ Hong Kong SAR °¡ PIC/S ȸ¿ø °¡ÀÔÀ» ½ÅûÇÏ¿´´Ù. Hong Kong SAR applies for PIC/S membership Geneva, 10 September 2013: On 30 August 2013 Hong Kong SAR's Pharmacy and Poison Board applied for PIC/S membership. The Rapporteur....
¹Ì ÇàÁ¤ºÎ Æó¼â¿¡ µû¸¥ FDA Contingency Staffing Plan
2013-10-02
¹Ì±¹ ¿¬¹æÁ¤ºÎ°¡ 1ÀÏ »õº® 0½Ã 1ºÐÀ» ±âÇØ ¾÷¹« Æó¼â¿¡ µé¾î°¬Áö¸¸ ¸ðµç ±â°üµéÀÌ ¹®À» ´Ý´Â °ÍÀº ¾Æ´Ï´Ù. ±¹¹ÎÀÇ ¾ÈÀü, »ý¸í ±×¸®°í Àç»ê¿¡ Á÷°áµÇ´Â ÇÙ½É ¾÷¹«µéÀº Á¤»ó °¡µ¿µÈ´Ù. Á¤ºÎÀÇ »çȸº¸Àå ÀǷẸÇè ÇýÅõµ ¿©ÀüÈ÷ Á¦°øµÇ°í, ÀÚü ¿¹»êÀ¸·Î ¿î¿µµÇ´Â ¿ìü±¹µµ ¿ìÆí¹° Áý¹è¼Û ¾÷¹«¸¦ °è¼ÓÇÑ´Ù. FDA°¡ º¸°íÇÑ ¡°Contingency Staffing Plan for FDA Operations in the Absence of Enacte....
USP General Chapter <671> °³Á¤¾È ¹ßÇ¥
2013-09-20
Pharmacoeial Forum39(2)¿¡ USP General Chapter <671> °³Á¤¾ÈÀÌ ¹ßÇ¥µÇ¾ú´Ù. À¯È¿±â°£ µ¿¾È Á¦Ç°ÀÇ Ç°ÁúÀ» À¯ÁöÇϱâ À§Çؼ´Â Æ÷ÀåÀÇ ¿ÏÀü¼ºÀÌ Áß¿äÇÏ´Ù. BlisterÀÇ Åõ½Àµµ¿¡ °üÇÑ ½ÃÇè¹ýÀÌ »õ·ÎÀÌ Æ÷Ç﵃ ¿¹Á¤ÀÌ´Ù.»ó´ë½Àµµ 75% ¿Âµµ 40µµ¿¡¼ moisture vapour transmission rates±âÁØÀ» ´ÙÀ½°ú °°ÀÌ Á¦½ÃÇϰí ÀÖ´Ù.¡¤ Low-barrie....
ASEAN: Process Validation Guidance ÃÊ¾È ¹ßÇ¥
2013-09-05
ASEAN ±¹°¡¿¡¼ Singapore°¡ ÁÖ°üÀÌ µÇ¾î Process Validation¿¡ °üÇÑ Guidance(draft)¸¦ ¹ßÇ¥Çß´Ù.¡° http://www.gmp-navigator.com/elements/PDF/Asean_PV_Guideline.pdf¡° ¿¡¼ º¼ ¼ö ÀÖ´Ù.ÀÌ ¹®¼´Â Guidance for Quality by Design as an alternative Approach to Process ....
WHO GMP Guide °³Á¤ ÀÛ¾÷ Áß
2013-08-14
WHO GMP Gudie´Â 1967³â óÀ½ ¹ßÇàµÈ ÀÌÈÄ °³Á¤À» °ÅµìÇÏ¿© 2011³â Technical Report Document TRS 961ÀÇ Annex 3À¸·Î ÃÖÁ¾ ¹ßÇ¥µÇ¾ú´Ù. ÀÌ ¹®¼°¡ WHOÀÇ ¸ðµç GMP¹®¼ÀÇ ¸ðŰ¡ µÇ°í ÀÖ´Ù.À̹ø °³Á¤¾È¿¡¼´Â ´ÙÀ½ »çÇ×ÀÌ ¹Ù²î°í ÀÖ´Ù.Chapter 1. Pharmaceutical quality system (formerly "quality assurance")Chapter 2. Good Ma....
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