回顧的バリデーションが許されなくなった訳とは

2013年8月30日に「医薬品及び医薬部外品の製造管理及び品質管理の基準に関する省令の取扱いについて」(薬食監麻発0830第1号 厚生労働省医薬食品局監視指導・麻薬対策課長)が通知された。
これにより、平成17年3月30日付け薬食監麻発第0330001号「薬事法及び採血及び供血あつせん業取締法の一部を改正する法律の施行に伴う医薬品、医療機器等の製造管理及び品質管理(GMP/QMS)に係る省令及び告示の制定及び改廃について」(GMP施行通知)が改正された。
その中でバリデーション基準が全面改定された。
バリデーション基準では「回顧的バリデーション」が削除された。
FDAの最新のプロセスバリデーションのプラクティスや、EU GMPではすでに回顧的バリデーションというものは存在しなかった。
2015年10月1日に改定されたPIC/S GMP ANNEX 15「適格性評価とバリデーション」においてもやはり回顧的バリデーションが削除された。

バリデーションは、あくまでも予測的に実施することが原則であり、回顧的バリデーションはもはや許されない

では、そもそもなぜ回顧的バリデーションという手法が存在したのだろうか。
それは、食品や化学品などの異業種で設置された構造設備を医薬品製造に転用させた際に実施するという意味合いだったのである。
つまり異業種では構造設備を導入する際にバリデーションを実施していないため、医薬品を製造する際に改めて回顧的に実施することになった訳である。

もはや異業種から転用するケースはあり得ないという判断である。

なお、上記のバリデーション基準では、CSVについては言及されていない。
H/Wは経年劣化するため、定期的に再バリデーション(再適格性評価)が必要である。
しかしながらS/Wは経年劣化することもないし、故障することもない。
したがって、S/Wには再バリデーションという概念はないのである。
ただし、一般にS/WはH/Wに比べて頻繁に変更が発生する。
そのため、変更時のバリデーションが重要となる。

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