医療機器製造とプロセスバリデーション 

医療機器製造とプロセスバリデーション

ISO 13485:2016には、プロセスバリデーションに関して下記の要求がある。

7.5.6　製造およびサービス提供に関するプロセスバリデーション
製造およびサービス提供の過程で結果として生じるアウトプットが、それ以降の監視または測定で検証することが不可能または検証を実施せず、その結果、製品が使用され、またはサービスが提供された後でしか不具合が顕在化しない場合には、組織は、その製造およびサービス提供の該当するプロセスバリデーションを行う。
バリデーションによって、これらのプロセスが計画どおりの結果を一貫して出せることを実証する。

また同様にFDA QSR（21 CFR 820）には、下記の要求がある。

820.75　プロセスバリデーション
工程の結果が事後の検査及び試験によって十分には検証できない場合、高い信頼度によって妥当性確認され、確立された手順に従って承認されること。妥当性確認の活動及び結果は、日付、及び妥当性確認を承認した者（1人または複数）の署名も含めて、そして適切な場合は妥当性確認された主要装置も含めて、文書化されること。

つまりプロセスバリデーションは、製造工程の結果が検査や試験では十分に検証できない場合（つまり特殊工程）に実施する。
特殊工程とは、破壊検査を含む工程のことである。代表的な例としては、半田付け、かしめ、滅菌、溶接、溶着、接着等がある。
破壊検査を実施すると製品として出荷できなくなってしまう。そのため、これら特殊工程においては、サンプリング検査を実施しなければならない。
サンプリング検査は、全数検査とは異なり、製品の品質を100%保証することは出来ない。
そのため、検査結果等で品質を保証するのではなく、あらかじめ当該特殊工程が100%品質が保証できるようにプロセスをバリデーションしておかなければならないのである。
これがプロセスバリデーションである。

対象工程がコンピュータ化システムである場合には、プロセスバリデーションに先立って事前にソフトウェアバリデーション（CSV）を実施しなければならない。
また対象工程が手技によるものである場合（例：手半田）は、事前にプロセスバリデーションを実施する要員の資格認定が必要である。
つまり力量を持った要員のみがプロセスバリデーションを実施でき、当該特殊工程を担当することが出来るのである。

筆者がある国産大手医療機器企業の監査を実施したことがあった。
その際に半田付けを実施している作業員の訓練記録における技能テストの記録を精査した。
なんとその要員の技能テスト結果が60点であった。
監査報告書に「半田付けの技能テストが60点の要員に特殊工程を担当させている。」と指摘をしたところ、当該被監査部門から反論が来た。
「半田付けの技能テストの結果が60点で合格か不合格は監査員の個人的な基準や意見であって、受け入れることが出来ない」というものであった。
読者はどう考えるだろうか。
筆者は「半田付けは100点をとれる要員しか実施してはならない。もし60点の者が半田付けを実施した場合、100ヶ所の半田付けに対して60ヶ所もしくじるではないか。」と応答した。
当該企業の品質保証に対する知識の欠如に呆れる。
プロセスバリデーションのゴールは、100%の品質保証でなければならない。
滅菌の場合は、100%滅菌できることがプロセスバリデーション（滅菌バリデーション）によって保証されなければ（実際にはSAL 10-6）出荷してはならないのである。

関連商品

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