

| Á¦¸ñ | [EMA] EMA publishes final Version of Q&A Paper on Production of water for injections | ||
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| µî·ÏÀÏ | 2017-09-06 | Á¶È¸¼ö | 1,327 |
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| ³»¿ë | ¾È³çÇϼ¼¿ä. 2017³â 4¿ù 1ÀÏ ÀÌÈÄ·Î À¯·´¾àÀü¿¡¼´Â ÁÖ»ç¿ë¼ö(WFI : Water For Injections) Á¦Á¶¿¡ Áõ·ù°¡ ¾Æ´Ñ ´Ù¸¥ ¹æ¹ýÀÌ °¡´ÉÇϵµ·Ï º¯°æÇÏ¿´°í, EMA¿¡¼´Â Ãß°¡ °¡À̵å¶óÀÎ(Q&A Paper) À» 2017³â 8¿ù 1ÀÏ final ¹öÀüÀ¸·Î ¹ßÇàÇÏ¿´½À´Ï´Ù. http://www.ema.europa.eu/docs/en_GB/document_library/Other/2017/08/WC500232814.pdf °¨»çÇÕ´Ï´Ù. |
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| ÀÌÀü±Û | [ICH] ICH Q4B - Harmonisation relating to the Sterility Test |
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| ´ÙÀ½±Û | [MFDS] ÀǾàǰ µîÀÇ µ¶¼º½ÃÇè±âÁØ ÀϺΰ³Á¤°í½Ã |
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