著者

竹澤 健一 片山 博仁 田中 広徳 田村 圭史郎 中村 みさ子 三宅 正一 室井 哲夫 百永 眞士 山岡 尚志 涌田 俊哉

出版者

一般社団法人日本PDA製薬学会

雑誌

日本PDA学術誌 GMPとバリデーション (ISSN:13444891)

巻号頁・発行日

vol.8, no.1, pp.78-86, 2006 (Released:2007-05-10)

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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). 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. 1)  Deviation from the standard operating procedure in granulation process 2)  Deviation from the specification in pharmaceutical water 3)  Deviation from the humidity limit in stability chamber 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.