執筆者:望月 清



第30回 データインテグリティの是正(2) ウォーニングレターにおける常とう句

B. A current risk assessment of the potential effects of the observed failures on the quality of your drugs. Your assessment should include analyses of the risks to patients caused by the release of drugs affected by a lapse of data integrity, and risks posed by ongoing operations.
B. 現時点におけるリスク評価

B. 現時点におけるリスク評価
A-3およびA-4において、どのようなデータインテグリティ不適がどの部分でどの期間発生していたかが把握される。そのようなデータインテグリティ不適合の環境下で出荷された医薬品が、患者に対しどのようなリスクを及ぼすか分析する。その分析結果を基に、後述する「C-3 暫定処置」を実施する。必要に応じ、参考品により確認試験を行いリスクを評価する。

5.経営戦略 (C)
C. A management strategy for your firm that includes the details of your global corrective action and preventive action plan. Your strategy should include:
C-1 A detailed corrective action plan that describes how you intend to ensure the reliability and completeness of all of the data you generate, including analytical data, manufacturing records, and all data submitted to FDA
C-2 A comprehensive description of the root causes of your data integrity lapses, including evidence that the scope and depth of the current action plan is commensurate with the findings of the investigation and risk assessment. Indicate whether individuals responsible for data integrity lapses remain able to influence CGMP-related or drug application data at your firm.
C-3 Interim measures describing the actions you have taken or will take to protect patients and to ensure the quality of your drugs, such as notifying your customers, recalling product, conducting additional testing, adding lots to your stability programs to assure stability, drug application actions, and enhanced complaint monitoring.
C-4 Long-term measures describing any remediation efforts and enhancements to procedures, processes, methods, controls, systems, management oversight, and human resources (e.g., training, staffing improvements) designed to ensure the integrity of your company’s data.
C-5 A status report for any of the above activities already underway or completed.

C. 経営戦略
C-1 詳細な是正処置計画
C-2 根本原因の説明
C-3 暫定処置
C-4 長期方策
C-5  状況報告

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望月 清

望月 清

1973年山武ハネウエル株式会社(現アズビル)入社。分散型制御システム(DCS)を米国ハネウエル社と分担開発。2002年よりPart 11およびコンピュータ化システムバリデーションのコンサルテーションを大手製薬会社にご提供。2009年より微生物迅速測定装置の啓蒙普及に従事。2014年5月より現職。