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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....
¹Ì FDA : 2010ÀÌÀü Draft Guidance Àç°ËÅäÇÏ¿© Á¾°áÁþ°Å³ª Æó±â 2013-08-14
ÀÌ ´Þ 7ÀÏ ¹Ì FDA´Â Federal Register¿¡ "Retrospective Review of Draft Guidance Documents Issued Before 2010; Withdrawal of Guidances".¶ó´Â Á¦¸ñÀÇ °ø°í¹®À» °ÔÀçÇÏ¿´´Ù.FDA´Â 2010³â ÀÌÀü¿¡ ¹ßÇàÇÑ Draft GuidanceµéÀ» °ËÅäÇÏ¿© Á¾°á Áþ°Å³ª Æó±âÇÒ °èȹÀÌ´Ù. ÀÌ´Â 2000³â 9¿ù ÃÖÁ¾ È®Á¤ÇÑ ¡°Administrative Practic....
Çѱ¹Á¦¾à±â¼ú±³À°¿ø: º¸°Ç»ê¾÷ÁøÈï¿øÀ¸·ÎºÎÅÍ ¡®À§Å¹±³À°±â°ü¡¯À¸·Î ÁöÁ¤ 2013-07-09
 Çѱ¹Á¦¾à±â¼ú±³À°¿ø(¿øÀå ¹é¿ìÇö. ÀÌÇÏ ±³À°¿ø)Àº Çѱ¹º¸°Ç»ê¾÷ÁøÈï¿ø(¿øÀå °í°æÈ­. ÀÌÇÏ ÁøÈï¿ø)À¸·ÎºÎÅÍ ¡°Á¦¾à»ê¾÷ Á¾»çÀÚ Àç±³À°¡±ÀÇ À§Å¹±³À°±â°üÀ¸·Î ÁöÁ¤µÇ¾î Á¤ºÎ·ÎºÎÅÍ ±³À°ºñ Áö¿øÀ» ¹Þ°Ô µÇ¾ú´Ù. ÁøÈï¿øÀÌ ÁÖ°üÇÏ´Â Àç±³À° Áö¿ø»ç¾÷Àº º¹ÁöºÎÀÇ ÈÄ¿øÀ» ¹Þ¾Æ Á¦¾à»ê¾÷¿¡ ±Ù¹«ÇÏ´Â Á¾¾÷¿ø¿¡ ´ëÇØ ü°èÀûÀÎ ±³À°À» ÅëÇØ¼­ Á¦¾à Àü¹®ÀηÂÀ» ¾ç¼ºÇÏ´Â µ¥ ¸ñÀûÀ» µÎ°í ÀÖÀ¸¸ç GMP ½Ç¹«, R&D ±âȹ, ÀÎÇã°¡, ÀÓ»ó½ÃÇè µî ³× ....
EU Gudielines addopted in Australia 2013-06-14
ÀÌ´Þ 3ÀÏ TGA(Australian Therapeutic Goods Administration)Àº The Rules Governing Medicinal Products in the European Union - EudraLex - Medicinal products for human and veterinary use, 1997 Edition: Volume 4 - Pharmaceutical Legislation - Good Manufac....
2013 COPHEX: 28ÀϺÎÅÍ KINTEX¿¡¼­ 2013-04-24
Çѱ¹Á¦¾àÇùȸ, °æ¿¬Àü¶÷ÀÌ °øµ¿ÁÖÃÖÇÏ´Â Á¦8ȸ Á¦¾àÈ­Àåǰ±â¼úÀü(COPHEX 2013)ÀÌ ¿À´Â 5¿ù 28ÀϺÎÅÍ 4Àϰ£ÀÇ ÀÏÁ¤À¸·Î °æ±â °í¾ç ŲŨ½º Á¦1Àü½ÃÀå¿¡¼­ ¿­¸°´Ù. À̹ø Àü½Ãȸ¿¡¼­´Â Á¦¾à, È­ÀåǰÀÇ Ç°Áú°ü¸® Çâ»óÀ» À§ÇÑ Á¦Á¶, ÇÁ·Î¼¼½Ì, °ü¸®, ¾Æ¿ô¼Ò½Ì °ü·Ã ´Ù¾çÇÑ Ãֽűâ¼úÁ¤º¸¸¦ È®ÀÎÇÒ ¼ö ÀÖ´Ù. ±¹³» ŸÁ¤±â ¸ÞÀÌÄ¿ÀÎ PTK´Â À̹ø Çà»ç¿¡¼­ °¡Àå Å« ºÎ½º±Ô¸ðÀÎ 45ºÎ½º¸¦ ¸¶·ÃÇÏ¿© Á¤Á¦¾ÐÃ༺Çü±â, Á¤Á¦ÄÚÆÃ±â, °í¼Ó ¹Í¼­±â, ĸ½¶Ãæ....
FDA: SUPAC: Manufacturing Equipment Addendum ÃÊ¾È 2013-04-13
FDA´Â ÀÌ´Þ ÃÊ SUPAC-IR/MR: Immediate Release and Modified Release Solid Oral Dosage Forms, Manufacturing Equipment Addendum and SUPAC-SS Nonsterile Semisolid Dosage Forms, Manufacturing Equipment Addendum.¸¦ Æó±âÇϰí À̵éÀ» ÅëÇÕÇÏ´Â »õ·Î¿î Guidance for Industry SU....
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