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GMP Case Study: Lessons from FDA 483s & Warning Letters

 

 


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¹Ì±¹ FDAÀÇ GMP ½Ç»ç¿¡¼­ ÁöÀûµÈ ½ÇÁ¦ »ç·Ê(FDA 483 ¶Ç´Â Warning Letter)¿Í GMP Á¤º¸ µîÀ» e-newsletter·Î Á¦°øÇÕ´Ï´Ù.

 

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gmpeye´Â °³ÀÎ Á¤º¸¸¦ ¼öÁýÇÏÁö ¾Ê½À´Ï´Ù. ±×·¯¹Ç·Î °£´ÜÇÏ°Ô "´º½º·¹ÅÍ ½Åû"À̶ó°í Á¦¸ñÀ» ½á¼­ ¸ÞÀÏÀ» Áֽøé e-newsletter¸¦ º¸³»µå¸³´Ï´Ù. e-newsletter ¼ö½ÅÀ» ¿øÇÏÁö ¾Ê´Â ºÐÀº "´º½º·¹ÅÍ °ÅºÎ"¶ó°í Á¦¸ñÀ» ½á¼­ ¸ÞÀÏÀ» ÁÖ½Ã¸é ¸®½ºÆ®¿¡¼­ »èÁ¦ÇϰڽÀ´Ï´Ù.

 

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¹Ì±¹ FDAÀÇ GMP ½Ç»ç »ç·Ê ¹®¼­´Â GMP ¾÷¹«¸¦ °³¼±ÇÏ°í ±ÔÁ¦ ±â°üÀÇ GMP ½Ç»ç¸¦ ´ëºñÇϴµ¥ µµ¿òÀÌ µÇ¸®¶ó »ý°¢ÇÕ´Ï´Ù. GMP Case Study ¹®¼­¸¦ Àμ⠰¡´ÉÇÑ PDF ÆÄÀÏ·Î ÆÇ¸ÅÇϰí ÀÖÀ¸´Ï, ±¸ÀÔÀ» ¿øÇϽô ºÐÀº ¾Æ·¡·Î ¿¬¶ô Áֽñ⠹ٶø´Ï´Ù.

 

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GMP Case Study: Lessons from FDA 483s & Warning Letters (~ 2015³â)

 

GMP Case Study: Lessons from FDA 483s & Warning Letters - Volume 1 (ÃÑ 156 ÆäÀÌÁö)

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GMP Case Study: Lessons from FDA 483s & Warning Letters - Volume 2 (ÃÑ 163 ÆäÀÌÁö)

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GMP Case Study: Lessons from FDA 483s & Warning Letters - Volume 3 (ÃÑ 155 ÆäÀÌÁö)

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GMP Case Study: Lessons from FDA 483s & Warning Letters - Volume 4 (ÃÑ 165 ÆäÀÌÁö)

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GMP Case Study: Lessons from FDA 483s & Warning Letters - Volume 5 (ÃÑ 154 ÆäÀÌÁö)

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GMP Case Study: Lessons from FDA 483s & Warning Letters - Volume 6 (ÃÑ 151 ÆäÀÌÁö)

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GMP Case Study: Lessons from FDA 483s & Warning Letters - Volume 7 (ÃÑ 216 ÆäÀÌÁö)

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GMP Case Study: Lessons from US FDA Warning Letters 2016 (ÃÑ 251 ÆäÀÌÁö)

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GMP Case Study: Lessons from US FDA Warning Letters 2017 (ÃÑ 378 ÆäÀÌÁö)

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GMP Case Study: Lessons from US FDA Warning Letters 2018 (ÃÑ 440 ÆäÀÌÁö)

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GMP Case Study: Lessons from US FDA Warning Letters 2019 (ÃÑ 429 ÆäÀÌÁö)

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GMP Case Study: Lessons from US FDA Warning Letters 2020 (ÃÑ 418 ÆäÀÌÁö)

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GMP Case Study: Lessons from US FDA Warning Letters 2021 (ÃÑ 451 ÆäÀÌÁö)

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GMP Case Study: Lessons from US FDA 483s 2020/2021 (ÃÑ 221 ÆäÀÌÁö) New

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GMP Case Study: Lessons from US FDA 483s 2022³â »ó¹Ý±â (ÃÑ 110 ÆäÀÌÁö) New

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