逸脱管理に関する事例研究～よりよい逸脱管理のために～

DOI

書誌事項

タイトル別名
  • Case Studies on How to Handle Deviations ~Points to be Considered for a More Appropriate Handling~

説明

In the revised “GMP Ministerial Ordinance on Drugs and Quasi-drugs” announced by MHLW in December 2004, “deviation control” was stipulated. In response to this, Manufacturer needs to prepare SOPs to control and handle deviations appropriately and any deviation has to be documented. When critical deviation is occurred, impact assessment on the quality has to be also performed. If the deviation may have quality impact, the deviation has to be notified to Licensed Marketing Approval Holder of the product. Therefore, manufacturing unit or quality unit in manufacturer is required to have sufficient knowledge and ability to execute root cause analysis, impact assessment and corrective action/preventative action (CAPA).<br> In this article, by taking up the following three cases, how to handle deviations such as root cause analysis, impact assessment of quality and CAPA has been discussed.<br> 1)  Deviation from the standard operating procedure in granulation process<br> 2)  Deviation from the specification in pharmaceutical water<br> 3)  Deviation from the humidity limit in stability chamber<br> In each case, insufficient handling example is first introduced and then desirable way of thinking is shown along with appropriate example. Points to be considered are also discussed for a more appropriate handling.<br>

収録刊行物

キーワード

詳細情報 詳細情報について

  • CRID
    1390282679450081280
  • NII論文ID
    130004493536
  • DOI
    10.11347/pda.8.78
  • ISSN
    18811728
    13444891
  • 本文言語コード
    ja
  • データソース種別
    • JaLC
    • CiNii Articles
  • 抄録ライセンスフラグ
    使用不可

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