ÀÚ·á½Ç
  • GMP °¡À̵å¶óÀÎ
  • ÇÁ·Î±×·¥ ´Ù¿î·Îµå
  • ±â¾÷ȸ¿ø ÀÚ·á½Ç
GMP °¡À̵å¶óÀÎ
±¸ºÐ¼±
GMP °¡À̵å¶óÀÎ °Ô½ÃÆÇ
Á¦¸ñ [FDA] MAPP 5016.1 Applying ICH Q8(R2), Q9, and Q10 Principles to CMC Review
µî·ÏÀÏ 2016-06-24 Á¶È¸¼ö 1,823
÷ºÎÆÄÀÏ UCM242665.pdf  
³»¿ë

FDA¿¡¼­ MAPP(Manual of Policies and Procedures) 5016.1  Applying ICH Q8(R2), Q9, and Q10 Principles to Chemistry, Manufacturing, and Controls Review ¸¦ °³Á¤ ¹ßÇ¥ÇÏ¿´½À´Ï´Ù.

°¨»çÇÕ´Ï´Ù.

GMP °¡À̵å¶óÀÎ °Ô½ÃÆÇ ÀÌÀü±Û
ÀÌÀü±Û [MFDS] ÀǾàǰµîÀÇ ¾ÈÁ¤¼º½ÃÇè±âÁØ ÀϺΠ°³Á¤ °í½Ã
GMP °¡À̵å¶óÀÎ °Ô½ÃÆÇ ´ÙÀ½±Û
´ÙÀ½±Û [WHO]Guidance on good data and record management practices(Annex 5)
¸®½ºÆ®