製薬企業や医療機器企業は規制要件を遵守する必要がある。また供給者も同様に規制要件に適合する原料・材料・資材等を製造し、供給する責任がある。
しかしながら、供給者に規制要件を教育し、また要求される品質を担保させることは容易ではない。
2008 年には、ヘパリン ナトリウムの副作用により米国で 81 名が死亡した。その原因は中国の原薬製造メーカーが偽薬を混入したためである。
ヘパリンナトリウムは、抗血液凝固剤として使用される。
もともとは原料を牛の腸の粘膜から採取していたが、BSE問題により豚から採取することに変更となった。
しかし、四川大地震により豚の価格が高騰したため、中国の原薬製造メーカがHPLCのピークがヘパリンナトリウムとよく似た物質を混入させたのである。
事件発覚後、FDA は 原薬を輸出した中国の製薬会社を一度も査察していな かったことが発覚した。
それ以降、FDAは2008年に上海を拠点に中国に4ヶ所の事務所を設置した。当初はFDAから7人と中国人8名の計15名で中国の製薬企業の監視を始めた。
またインドに関しても同様の監視を行っている。
現在では、米国外では珍しい非通知査察（事前の予告をしないで査察が実施される）が実施されている。
日経ビジネスONLINEに興味深い記事が掲載されていたので、以下、引用し一部変更して紹介したい。
「供給者管理に関しては、アップル社の取り組みが参考になる。アップル社のホームページには「サプライヤー責任」と題して取り組みを公開している。
供給者の責任は「説明責任」「労働者の権利と人権」「従業員の支援」「環境、健康と安全」「報告書」の5つのパートで構成されている。
アップル社は供給者への監査を通じてサプライヤーの管理状況の掌握に取り組んでいる。
注目すべきは、同時に行っている教育プログラムに代表されるサプライヤーへの支援だ。アップルのサプライヤー責任のトップページには「説明責任」についてアップルの考え方を明らかにしている。
供給者の管理レベルを設定し、一定期間ごとに監査を行っている企業は多いだろう。
しかしアップル社は、そういった管理状況の説明責任を課しているだけではなく、供給者が自ら責任を全うするために必要なスキルを獲得する「サポート」を提供している。
アップル社が供給者への教育に代表されるサポートを前面に出すのは、取り引きを行っているサプライヤー数が少なく、ほぼすべてのサプライヤーに教育が行き届いているからであろう。
2016年2月に公開された「Supplier List」によると、上位200社のサプライヤーで、購入額の97％を占める集中購買を実現させている。
サプライヤー監査の回数は2015年で640件を数えており、これは97％を占めるサプライヤーを年3回監査している計算になる。」
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