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PMDA: ÀϺ»¾à±¹¹æ Á¦17°³Á¤ ¹ßÇà 2016-03-11
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ISO 14644 °³Á¤ÆÇ µåµð¾î ¹ßÇàµÇ¾ú´Ù 2015-12-11
1999³â óÀ½ ³ª¿Â ISO 14644°¡ µåµð¾î °³Á¤ÀÌ È®Á¤µÇ¾î ¹ßÇàµÇ¾ú´Ù. ISO 14644-1:2015 Cleanrooms and associated controlled environments-Part 1: Classification of air cleanliness by particle concentration. Second edition 2015-12-15ISO 14644-2:2015 Cleanrooms and a....
GMP Update & Technology Follow-up Á¦16±Ç Á¢¼ö °³½Ã 2015-10-31
GMP Update & Technology Follow-up Á¦16±Ç(2015³â °¡À»È£) ¹ßÇàÀÌ ¼øÁ¶·Ó°Ô ÁøÇàµÇ°í ÀÖ´Ù.GMPÇöÀåÀÇ Àü¹®°¡¿Í ±¹³»¿Ü ¾÷°è ±ÇÀ§ÀÚÀÇ ÁÖ¿Á °°Àº ¿ø°í°¡ È­·ÁÇÑ ÆäÀÌÁö·Î µðÀÚÀεǾî ÀÌÁ¦ Àμ⸦ À§ÇÑ ¸¶Áö¸· ±³Á¤ ÀÛ¾÷¿¡ ÀÖ´Ù. 11¿ù ¸¶Áö¸· ÁÖ¿¡ ¹ßÇàµÇ¾î ¹èÆ÷¸¦ ½ÃÀÛÇÒ ¿¹Á¤ÀÌ´Ù.¼±Âø¼ø Á¢¼öÇÏ¿© ¹«·á ¹èÆ÷ÇϹǷΠ´ÊÁö ¾Ê°Ô ½ÅûÇØ¾ß ÇÒ °ÍÀÌ´Ù. Part 1, 2ÀÇ ÁÖ¿ä ³»¿ëÀº ´ÙÀ½°ú °°´Ù.Part ....
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ICH´Â Áö³­ 23ÀÏ µ¿ Á¶Á÷ÀÇ ¸íĪÀ»    The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use(ICH) ·Î ¹Ù²Ù°í Á¶Á÷À» °³ÆíÇÏ¿´´Ù°í ¹ßÇ¥Çß´Ù. ICH´Â ÁøÁ¤ÇÑ global initiative¸¦ °­Á¶ÇÏ....
Çѱ¹ PDA: Global GMPs Q&A ¹ß°£ 2015-10-28
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WHO: ºñ¹«±ÕÁ¦Á¦ HVAC °¡À̵å¶óÀÎ °³Á¤ ÃÊ¾È ¹ßÇ¥ 2015-10-26
WHO´Â 2011³â WHO Technical Report Series, No. 961ÀÇ Annex 5·Î ¹ßÇàÇÏ¿© ÇöÀç±îÁö À¯È¿ÇÑ Supplementary guidelines on good manufacturing practices for heating, ventilation and air-conditioning systems for non-sterile pharmaceutical dosage forms ¸¦ °³Á¤ÇÏ·Á°í ....
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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....
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