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[Translation from English to Japanese ] The acceptable limits for particles should be based on the knowledge and hist...
Original Texts
The acceptable limits for particles should be based on the knowledge and history of regular
process and equipment performance. Any equipment, process or human failure can lead to
increased level of particles in the API. If there is no indication of such a failure and the
testing results of the API are within the predefined acceptable limits the batch can be
considered acceptable and there is no need to further investigate. Specific action and alert
limits might be applied to ensure that any evolving process and/or performance issues can be
detected and mitigated prior to exceeding the predefined action limits.
process and equipment performance. Any equipment, process or human failure can lead to
increased level of particles in the API. If there is no indication of such a failure and the
testing results of the API are within the predefined acceptable limits the batch can be
considered acceptable and there is no need to further investigate. Specific action and alert
limits might be applied to ensure that any evolving process and/or performance issues can be
detected and mitigated prior to exceeding the predefined action limits.
粒子の受領制限は知識、普通のプロセスの履歴及び機械の性能に依拠するべきです。機械、プロセスまたは人的な失敗はAPIにおける粒子の増幅をもたらします。このような失敗及びAPIのテストの結果が事前に決定された受容制限内であれば、バッチが受領されると見なされ、それ以上の調査は不要です。特殊な行動及び警戒制限が適用され、これにより考えられるプロセス及び実行の問題が探知され、事前に定義された行動の制限を越える前に軽減されます。
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