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USP39-NF34 Chaper 1 °³Á¤ 2016-04-15
USP´Â 2016³â 5¿ù 1ÀÏ·Î ¹ßÈ¿ÇÏ´Â USP 39-NF 34¿¡ ¿Ã¸° Chapter <1> "Injections and Implanted Drug Products (Parenterals)-Product Quality Tests'À» ´Ù½Ã °³Á¤Çß´Ù°í ¹ßÇ¥Çß´Ù.»õ versionÀº 5¿ù 1ÀÏ ¹ßÈ¿ÇÑ´Ù.
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 ....
ICH: ¸íĪ ¹Ù²Ù°í Á¶Á÷ °³Æí 2015-10-29
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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