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ÃÄ«~¨ÑÀ³Ãì¦w¥þªk®×(The Drug Supply Chain Security Act, DSCSA)¤¶²Ð:±z·Ç³Æ¦n¤F¶Ü?

By Jennifer Petrosky ¡V2022¦~8¤ë18¤é,

Drug Supply Chain Security Act, DSCSA

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ÃÄ«~¨ÑÀ³Ãì¯Ê¥F¥i°l·¹©Ê¬O©Ò¦³³o¨Ç»â°ì¨ú±o¶i®iªº¤@­Ó»Ùê¡A¦ý¬ü°ê­¹«~©MÃĪ«ºÞ²z§½(FDA)¥¿¦b§V¤O³q¹L¡mÃÄ«~¨ÑÀ³Ãì¦w¥þªk®×¡n(DSCSA)§ïÅܳoºØª¬ªp¡C2023¦~11¤ë¥þ­±¥Í®ÄªºDSCSAÀ³¸Ó¬°¬ü°ê»sÃÄ·~±a¨Ó¤@­Ó¨ÑÀ³Ãì¼u©Êªº·s®É¥N¡A¦ý¦X³W©Ê¨Ã«D¨S¦³¬D¾Ô¡C

KPMG 2017¦~ªº¤@¶µ½Õ¬dµo²{¡A45%ªº¤½¥q¤w¸g¦bIT©M§Þ³N°ò¦³]¬I¤è­±§ë¸ê¤F5,000¸U¬ü¤¸¥H¤W¡A¥H¤ä«ù¦X³W¡CµM¦Ó¡A³o¨Ç§V¤O¤¤¦³³\¦h¦b¤j¬y¦æ¯f´Á¶¡³QÀÁ¸m¤F¡C¥þ²y¨ÑÀ³Ã줤²{¦³ªºº|¬}³Q¼ÉÅS¥X¨Ó¡A¤½¥q¥²¶·¨³³t±Ä¨ú¦æ°Ê¡A¥H¾¨¶q´î¤Ö¤¤Â_¯}Ãa¡C

¤µ¤Ñ¤½¥q¥¿¦b§V¤O¸Ñ¨M³\¦h¨ÑÀ³Ãì­·ÀI¡A¤Ï¬M¤FFDA§Æ±æ³q¹LDSCSA¸Ñ¨Mªº¬D¾Ô¡C¦X³W©Ò»Ýªº¬Û¦P°ò¦³]¬I¤]¥i¥HÀ°§U¤½¥q¸Ñ¨M¨ä¥L¥D­nªº¨ÑÀ³Ãì©M¹BÀç°ÝÃD¡A¦ý2023¦~11¤ë«Ü§Ö´N·|¨ì¨Ó¡A¤½¥q»Ý­n²{¦b´N¶}©l·Ç³Æ¡C

¤°»ò¬O¡mÃÄ«~¨ÑÀ³Ãì¦w¥þªk®×¡n(DSCSA)

ÃÄ«~¨ÑÀ³Ãì¯Ê¥F¥i°l·¹©Ê¹ï¤½¥q¨Ó»¡¬O¤@­Ó°ÝÃD¡A¹ï®ø¶OªÌ©M¬ü°ê­¹«~©MÃĪ«ºÞ²z§½¨Ó»¡¤]¬O¦p¦¹¡C¬ü°ê°ê·|¦b2013¦~11¤ë±Ä¨ú¦æ°Ê¡A³q¹L¹{§GÃÄ«~¨ÑÀ³Ãì¦w¥þªk®×¨Ó¥[±j³o¤@¨ÑÀ³Ãì¡A¸Óªk¬O¡mÃÄ«~«~½è©M¦w¥þªk®×¡n(Drug Quality and Security Act,²ºÙDQSA)ªº¤@³¡¤À¡C

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¾Ú¦X¦P¨îÃĤ½¥qºÙ¡A¸Óªk®×¥[§Ö¤FÃÄ«~¨ÑÀ³Ãì¼Æ¦ì¤ÆªºÂàÅÜ¡A¦ý³oÁÙ¤£°÷¡C±q2014¦~¨ì2019¦~¡AÃÄ«~³y°²®×¥óªº³W¼Ò¦h¤F¤@­¿¡A¦b2019¦~¹F¨ì¤F4,405°_ªº¾ú¥v·s°ª¡C¦P¦~¡A¥_¬ü¥X²{¤F³Ð¬ö¿ýªº»P¬r«~¦³Ãöªº½rÀò¶q¡A³o¨Ç½rÀò¶q·½©ó«DªkÃÄ«~¡C

¡mÃÄ«~«~½è©M¦w¥þªk®×¡n(Drug Quality and Security Act.)ªº¨â­Ó³¡¤À¬O¤°»ò?

¬ü°ê²³Ä³°|©M°Ñij°|¦b2013¦~²Î´N¡m½Æ¦XÃÄ«~©M¨ÑÀ³Ãì¦w¥þªk®×¡n(Compounding Quality Act and the Drug Supply Chain Security Act)¹F¦¨¤@­P¦@ÃÑ¡A§Î¦¨¨Ã³Ì²×½T©w¤F¡mÃÄ«~«~½è©M¦w¥þªk®×¡n(DQSA)¡C

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By Glenn Graney - 2022¦~7¤ë20¤é

preventive maintenance, predictive maintenance, PdM, enterprise asset management, QAD EAM

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