FDA査察において指摘をなくす方法について

筆者は2016年3月22日から3月26日までの1週間、ある企業のFDA査察に立ち会った、結果はNAI（指摘ゼロ）であった。
当社がFDA査察を支援した企業ではこれまで指摘ゼロを連続して受けており、連勝記録がまた更新された。

ちなみにFDA査察における査察結果のステータスには3種類ある。

  1. NAI（No Action Indicated）
  2. VAI（Voluntary Action Indicated）
  3. OAI（Official Action Indicated）である。

    NAIは、公式にFDA Form 483による指摘がないことを意味する、査察結果としては最高である。
    VAIは、重大な規制要件違反は見つからなかったが、自主的な改善が要求され、FDA Form 483が発行される。
    OAIは、重大な規制要件違反が発見され、FDA Form 483が発行されたうえで、即座にFDA本部からWarning Letterが発行される。
    例えば、重篤な有害事象の報告漏れやミスレーベリング、承認事項とは異なる製造方法などである。

ちなみにFDA Form 483は、文書に署名した上で企業に提供することが義務付けられている。
そのため、査察官によっては、携帯型のプリンターを持参してくる場合がある。（図参照）

場合によっては、査察官がFDA Form 483を電子データで企業に手渡し、クローズアウトミーティング後に最終版を作成したのち、電子署名を付す場合もある。

ところで、当社のコンサルティングにおいてどのようにFDA査察における指摘をなくしているかについてその一部を紹介したい。
日本の場合、FDA査察は約2～3ヶ月前に予告が来る、その際に当社では徹底的な品質監査を実施し、指摘を出す。
企業はその指摘に従って、CAPAを作成し改善計画を明確にする、できれば教育訓練も実施しておく方が良いだろう。
もし査察官が口頭でConcernを述べた場合、すみやかに企業自らが当該問題を認識しており、改善計画済であることをアピールするのである。
FDA査察官は、過去のエラーに対して指摘を出すのではなく、今後のリスクに対して指摘を出すわけなので、改善済の事項については、FDA Form 483を発行しない場合が多いのである。

また事前の品質監査で発見できなかった事項を査察官が述べた場合は、即座にCAPAを発行し、可能であれば該当する手順書を改訂してしまうのである。その上で査察官に即座に対応した旨をアピールすると良いだろう。

査察の進行状況はフロントヤード（査察を受ける部屋）からバックヤード（資料を探索する部屋）にExcelに入力した画面を共有しながら刻々と伝える。
一方で、最近のFDA査察において、当社ではスマートフォンのLINEを使用し、全関係者に筆者から状況に応じて指示を出している。
例えば即時のCAPAの起票における根本的原因、是正処置の内容などである。
バックヤードでは作成したCAPAや改訂したSOPを印刷し、それらをフロントヤードに提供し即座に査察官に提示するのである。

査察官のConcernを正確に理解し即座に改善計画を提出できる企業は、安心できる企業であるため、指摘がなくなる可能性が大きいのである。

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