FDA査察対応と『15分ルール』

近年、FDA 査察の頻度が増加している。これは、民主党のオバマ政権 の政策であると思われる。 FDA 長官は大統領が任命するため、政権の方針によって、 FDA の方針も影響を受けることが多い。
2004 年以降、FDA の査察はリスクベースに変更された。 したがって、リスクが高くない製品を米国に輸出している 企業に対しては、査察頻度はかなり低くなった。しかしなが ら、原材料(資材)等を中国やインドなどから輸入している 場合は、査察を受ける可能性がある。
また、FDA 査察の対象となる品目は、米国輸出品目とは限 らない。なぜならば、彼らは当該企業の「姿勢」に関心をも つからである。つまり米国輸出品目に関しては、査察の通知 を受けてから、十分に対応したであろうことは織り込み済で あるからである。
米国内の企業に対する査察は、最悪 1 日前に連絡が来るこ とがある。査察が数週間続き、徹底的に調査をされる。 一方で、米国外の企業の場合は、3 ヶ月程度前に査察の通 知がある。査察期間は、4~ 5 日程度であることが多い。
米国へ医薬品や医療機器を輸出している企業は、FDA 査察 を拒否することができない。 FDA 査察を拒否したり、査察で不合格になった場合は、米国税関当局で輸入が差し止められることにもなりかねない。
FDA 査察で重要なことは、不作成ドキュメントを後から作成してはならないという事である。ありのままで、正直に対 応する必要がある。
【15分ルール】
査察時には、査察官から要求された文書・記録を 15 分以 内で提示しなければならない。
15分ルールとは「査察官の要求に対し、15 分以内に適確な資料等を提示 しなければならない。」という暗黙のルールのことである。(実際に 明文化されているわけではない。)
そのためには、十分な資料(情 報)整理とリハーサルが不可欠である。
もし資料の提示に 15 分以上かかる場合は、“ 査察コーディ ネータ ” は、いつまでに(例:本日の午後、明日の朝など) 資料を提示できるかを説明し、次の質問に移ってもらうように要請しなければならない。
FDAは、2014年10月に「医薬品査察の遅延、拒否、制限、拒絶に相当する状況についてのガイダンス」を発行した。
連邦食品・医薬品・化粧品法(以下、FD&C法)に「査察の遅延、拒否、または制限あるいは立ち入りや査察を拒絶する工場、倉庫あるいは施設において、またそのような工場、倉庫あるいは施設の所有者、作業者あるいは代理業者によって製造、加工、 梱包又は保管された薬」を不良医薬品とみなす」
という条項が追加されたためである。
本ガイダンスでは、FDAが査察の遅延、拒否、制限、あるいは立ち入りや査察の拒絶とみなす行為、無行為および状況を定義している。

https://www.youtube.com/watch?v=YkMUUhjpWZE

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