ER/ES実践について研究するページです。
＊万が一文中に解釈の間違い等がありましても、当社では責任をとりかねます。
本文書の改訂は予告なく行われることがあります。
リスクベースアプローチの考察
1. はじめに
21 CFR Part 11（以下、Part11）は発効から10年が過ぎたが、その間に様々な問題点が浮き上がってきた。
そのひとつに電子記録の範囲が不明確で、あらゆる電子的な記録はPart11の対象となってしまい、対応範囲が際限なく広がってしまうという問題があった。
FDAは、2003年9月に「Guidance for Industry – Part 11, Electronic Records; Electronic Signatures – Scope and Application」を発行して、Part11の適用対象となる電子記録の範囲を狭く解釈するため、リスクベースアプローチをとることを推奨した。
さらにICHにおいても、2005年11月にQ9トピックとして品質リスクマネジメントに関するガイドラインの合意がなされた。
今年2月に改定されたGAMP 5においても、また現在パブリックコメントを募集しているANNEX 11においてもリスクベースアプローチをうたっている。
本稿では、欧米におけるリスクベースアプローチの採用の経緯と意義を考察したい。
2. なぜリスクベースアプローチか
医薬品はヒトの生命や健康に大きく寄与し、また直接ヒトの体内に投与されるものであるため、その品質においては厳格に管理がなされなければならない。
したがってこれまで規制当局により、歴史的に極めて厳しい規制が行われてきた。
一方において医薬品の承認までの時間が延長し、コストが高騰するなど医薬品開発は困難なものとなった。
また近年、承認される医薬品数が減少傾向にある。
規制当局においても、承認審査や査察のために大きなリソ一スが必要とされ、規制コストが増大している。
FDAは国家計画として、医薬品開発および承認審査を妨げる要因を解析し、これを克服するための戦略を打ち出した。
また同時に医薬品の品質管理においても、新しい考え方として品質リスク管理を提唱した。
医薬品の製造等における品質管理において、いたずらにコンプライアンスコストを高めるのではなく、リスクベースに基づいた科学的なアプローチによって、適切かつ妥当なレベルで対応することが望まれるのである。
リスクベースアプローチにより、コストの効果的かつ効率的な削減を行うことができる。
このようなFDAの戦略は、製薬企業と利害が一致し、ICHにおいてもトピックとして挙げられた。
3. FDAとリスクベースアプローチ
FDAは2002年8月21日のFDA NEWSで、21世紀のcGMPのイニシアティブのひとつとして、リスクベースアプローチを採用することを発表した。（図1参照）
図1 FDA News cGMP Initiative
FDAは業界等からPart11に対して多く寄せられた懸念を受けて、Part11および関連するガイダンス等を、cGMPイニシアティブに照らし合わせてレビュすることを決定した。
その結果、2003年2月4日のFederal Register (68 FR 5645)で「21 CFR Part 11; Electronic Records; Electronic Signatures, Electronic Copies of Electronic Records」の取り下げを発表した。その理由は、cGMPイニシアティブにおけるアプローチと矛盾がおきる可能性があるからであった。
その後、2003年2月25日のFederal Register (68 FR 8775) で、「Validation」「Glossary of Terms」「Time Stamps」「Maintenance of Electronic Records」の4つのガイダンスと、CPG7153.17についても取り下げを発表した。
FDAはこれらのガイダンスやCPGの再発行を考えていない。
さらに2003年9月には、「Guidance for Industry – Part 11, Electronic Records; Electronic Signatures – Scope and Application」を発行し、Part11の範囲と適用に関するFDAの考え方を発表した。
Part11においてもすべての電子記録に一様に対応するのではなく、リスクベースアプローチをとることを推奨し、次のように記述している。
「FDA が推奨するアプローチは、リスクアセスメントの正当化および文書化、そして製品の品質と安全性、記録の完全性に影響を及ぼす可能性をもつシステム判断することに重点をおいたアプローチである。」
FDAは2004年9月に「Pharmaceutical cGMPs for the 21st Century – A Risk-Based Approach Final Report – Fall 2004」と題した最終報告を発表した。
この中でcGMPイニシアティブとの整合性をはかるため、2005年中にPart11の改定案を発表することとし、1999年に発表した「Computerized Systems Used in Clinical Trials」についても改定することを記述している。
「Computerized Systems Used in Clinical Trials」は2007年5月に「Computerized Systems Used in Clinical Investigation」として発行された。
しかしながらPart11はいまだに改定案が発表されていない。
これはコンプライアンスコストの著しい上昇を避けなければならないという課題と、SOX法などにみられる電子記録の管理の厳格化といった相矛盾する問題に直面しているからではないかと推察する。
4. ICHとリスクマネジメント
日米欧医薬品規制調和国際会議（ICH）において、ICH Qトピックとして、品質に対して科学的なリスクに基づくアプローチをより進展することを促進する、Q8からQ10に至る一連の品質ガイドラインの国際調和が行われた。
中でもQ9は製薬業界および規制当局がツールとして適用できる品質リスクマネジメントに関するガイドラインである。
その序文では、次のように述べている。
「It is commonly understood that risk is defined as the combination of the probability of occurrence of harm and the severity of that harm.」
（一般に、リスクとは危害の発生する確率とそれが顕在化した場合の重大性の組み合わせであると認識されている。）
ここで、リスクとは危害の発生する確率であって、欠陥の発生する確率ではないことに注意が必要である。
またリスクの観点及びその評価は利害関係者によって異なる。
特に製薬企業では規制リスクを重要視しがちである。そこで序文では、
「In relation to pharmaceuticals, although there are a variety of stakeholders, including patients and medical practitioners as well as government and industry, the protection of the patient by managing the risk to quality should be considered of prime importance.」
（医薬品に関して言えば、患者、医療従事者、行政、企業等多様な利害関係者が存在しているものの、品質に対するリスクマネジメントを適用することにより患者を保護するということが最優先されるべきである。）
としており、いかなる利害関係者も「患者の保護」という観点では一致するはずだと指摘している。
Q9ガイドラインが掲げる品質リスクマネジメントの基本原則は以下の2つである。
- 品質に対するリスクの評価は、科学的知見に基づき、かつ最終的に患者保護に帰結されるべきである。
- 品質リスクマネジメントプロセスにおける労力、形式、文書化の程度は当該リスクの程度に相応すべきである。
Q9ガイドラインは2005年11月にICHで合意がなされ、厚生労働省から平成18年9月1日に、審査管理課長および監視指導・麻薬対策課長から「品質リスクマネジメントに関するガイドライン」と題した通知が発出されている。
総合機構ホームページから、ガイドラインとともにブリーフィング・パックがダウンロード可能である。
5. GAMP 5とリスクベースアプローチ
今年2月には6年ぶりにGAMPが改定され、GAMP 5が発表された。GAMP 5においてもFDAおよびICH Q9との整合を図るため、リスクベースアプローチを採用している。
そのため副題が「A Risk-Based Approach to Compliant GxP Computerized Systems」となっている。
リスクに基づいたコンピュータシステム・バリデーション（以下、CSV）の実施を求めているのである。
GAMP 5では、リスクアセスメントは科学的見地によって行われるべきであるとしている。
これまでのCSVにおけるリスクアセスメントの多くは、プロジェクトメンバーなどによる会議形式で決定されるものであった。しかしながら、時とメンバーが変わればそのリスク判定は異なるものとなる可能性がある。
つまり属人的なリスクの判定方法ではなく、あらかじめ定義されたチェックリストに基づくなど、再現性があり、対監査性のあるものでなければならないのである。
リスクアセスメントの手法は多くあるが、GAMPではFMEA（Failure Mode and Effect Analysis）に基づいている。FMEAは故障・不具合の防止を目的とした、潜在的な故障・不具合の体系的な分析方法である。
FMEAの考え方は「新しいものには必ず故障が存在する」ということである。
GAMP 5におけるリスクベースアプローチは、システムのライフサイクルにおける各種活動と作成するドキュメントの程度を、リスク・複雑さ・目新しさ（novelty）に応じて決定するというものである。
コンピュータシステムのCSVにおいては、予測される欠陥（不具合）をあらかじめ定量化しておかなければならない。そのためには欠陥の重大さ、発生頻度、検出可能性の3つの要素をあらかじめ明確にしておかなければならない。
そのアプローチは以下の2ステップからなる。
- 重大さとリスクの起こり易さを比較した図表を作成し、リスク分類を割り出す。
- リスク分類を検出確率を比較した図表を作成し、リスクの優先性を割り出す。
つまりリスクの大きさだけで判断するのではなく、検出可能性も考慮し、検出確率が低いものほど優先的に対応しないといけないというものである。
ちなみにGAMP 5では、データの完全性、製品の品質、患者の安全に大きく影響するコンピュータ化されたシステムによりフォーカスすべきであるとしている。
6. ANNEX 11の改定
EMEA（European Medicines Agency）は、2008年4月にEU GMPの付属資料の一つであるANNEX 11「Computerised Systems」の改定案を発表した。2008年10月31日までパブリックコメント（public consultation）を募集している。
現在のANNEX 11はたったの2ページであるが、改定案は9ページで原則（Principle）と19の章からなり、より具体性のあるものとなっている。（図2参照）
図2 ANNEX 11改定案目次
ANNEX 11の改定案においても、リスクマネジメントが筆頭に掲げられており、バリデーションとデータの完全性（Integrity）は、正当化され文書化されたリスクアセスメントの基づくべきであるとしている。
なおANNEX 11の改定に伴い、PIC/Sの改定も必至であると思われる。
7. おわりに
Part11やCSV等の規制やガイダンスは、品質に関する要件であり、GMPの要件の一つとして対応を要求されてきた。したがってGAMPやANNEX 11等の条文はGMPを中心とした記載がされている。
リスクマネジメントにおいて、患者を保護するという考え方はわかりやすいが、特に臨床開発部門においては読み換えが必要になると思われる。
具体的なリスクの評価方法についても検討が必要であろう。
リスクマネジメントは、リスクアセスメント、リスクコントロール、リスクコミュニケーション、リスクレビューの4つの要素からなる。
グローバル化が進む製薬業界において、リスクマネジメントを取り入れた、コンピュータシステムおよび電子記録・電子署名の品質保証を行う必要性がある。
GAMPやANNEX 11の改定に伴い、各社のSOPも改訂が進められていることと思うが、ぜひリスクベースアプローチの考え方を取り入れて頂きたい。
なお、文中においてGAMPはISPEの商標であることを申し添える。
参考
- 「Title 21 of the Code of Federal Regulations Part 11,“Electronic Records; Electronic Signatures”」 FDA 1997.3.20
- 「FDA NEWS: FDA Unveils New Initiative To Enhance Pharmaceutical Good Manufacturing Practices」FDA 2002.8.21
- 「Pharmaceutical cGMPs for the 21st Century: A Risk-Based Approach; A Science and Risk-Based Approach to Product Quality Regulation Incorporating an Integrated Quality Systems Approach」 FDA 2002.8.21
- 「Guidance for Industry: Part 11, Electronic Records; Electronic Signatures ? Scope and Application」 FDA 2003.9
- 「品質リスクマネジメントに関するガイドライン」 平成18年9月1日 薬食審査発第0901004号他 厚生労働省医薬食品局審査管理課長、監視指導・麻薬対策課長
- 「Guidance for Industry: Computerized Systems used in clinical investigations」 FDA 2007.5
- 「GAMP 5: A Risk-Based Approach to Compliant GxP Computerized Systems」 ISPE 2008.2
- “Pharmaceutical cGMPs for the 21st century – A risk-based approach” FDA 2004
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{Tôi rất vui để tìm thấy trang web tuyệt vời này. Tôi cần cảm ơn bạn {vì đã|dành thời gian cho|chỉ vì điều này|vì điều này|cho bài đọc tuyệt vời này!! Tôi chắc chắn thực sự thích từng một chút nó và tôi đã đánh dấu để xem thông tin mới trong trang web của bạn.|Tôi có thể chỉ nói rằng thật nhẹ nhõm để khám phá một người mà thực sự biết họ là gì đang nói về trên mạng. Bạn chắc chắn biết cách đưa một rắc rối ra ánh sáng và làm cho nó trở nên quan trọng. Nhiều người hơn nữa phải đọc điều này và hiểu khía cạnh này của. Tôi đã ngạc nhiên bạn không nổi tiếng hơn vì bạn chắc chắn sở hữu món quà.|Xuất sắc bài viết trên blog. Tôi chắc chắn đánh giá cao trang web này. Tiếp tục làm tốt!|Thật khó tìm những người có học thức về điều này, nhưng bạn có vẻ bạn biết mình đang nói gì! Cảm ơn|Bạn nên tham gia một cuộc thi dành cho một blog trên web tốt nhất. Tôi sẽ Rất khuyến nghị trang web này!|Một động lực chắc chắn đáng giá bình luận. Tôi nghĩ rằng bạn nên viết thêm về chủ đề này, nó có thể không là một điều cấm kỵ vấn đề nhưng nói chung mọi người không nói về vấn đề như vậy. Đến phần tiếp theo! Chúc mừng.|Xin chào! Tôi chỉ muốn đề nghị rất to cho thông tin xuất sắc bạn có ngay tại đây trên bài đăng này. Tôi sẽ là quay lại trang web của bạn để biết thêm thông tin sớm nhất.|Khi tôi ban đầu bình luận tôi có vẻ như đã nhấp hộp kiểm -Thông báo cho tôi khi có bình luận mới- và từ bây giờ bất cứ khi nào có bình luận được thêm vào tôi nhận được bốn email cùng chính xác một bình luận. Có một phương pháp dễ dàng bạn có thể xóa tôi khỏi dịch vụ đó không? Kudos.|Lần sau Tôi đọc một blog, Tôi hy vọng rằng nó sẽ không làm tôi thất vọng nhiều như bài này. Rốt cuộc, Tôi biết điều đó là sự lựa chọn của tôi để đọc, dù sao thì tôi thực sự nghĩ bạn sẽ có điều gì đó hữu ích để nói. Tất cả những gì tôi nghe được là một loạt khóc lóc về điều gì đó mà bạn có thể sửa nếu bạn không quá bận tìm kiếm sự chú ý.|Đúng với bài viết này, tôi thành thật cảm thấy trang web tuyệt vời này cần nhiều hơn nữa sự chú ý.
{Tôi rất hài lòng khám phá trang này. Tôi muốn cảm ơn bạn {vì đã|dành thời gian cho|chỉ vì điều này|vì điều này|cho bài đọc tuyệt vời này!! Tôi chắc chắn đánh giá cao từng của nó và tôi đã lưu làm mục ưa thích để xem thông tin mới trong trang web của bạn.|Tôi có thể chỉ nói rằng thật thoải mái để khám phá một cá nhân mà thực sự biết họ là gì thảo luận trên web. Bạn chắc chắn nhận ra cách đưa một vấn đề ra ánh sáng và làm cho nó trở nên quan trọng. Nhiều người hơn nữa phải kiểm tra điều này và hiểu khía cạnh này của. Tôi đã ngạc nhiên rằng bạn không nổi tiếng hơn vì bạn chắc chắn nhất sở hữu món quà.|Rất tốt bài đăng. Tôi hoàn toàn yêu thích trang web này. Tiếp tục làm tốt!|Thật khó đến những người có học thức về điều này, nhưng bạn nghe có vẻ bạn biết mình đang nói gì! Cảm ơn|Bạn cần là một phần của một cuộc thi dành cho một blog trên web tuyệt vời nhất. Tôi sẽ khuyến nghị blog này!|Một hấp dẫn chắc chắn đáng giá bình luận. Tôi tin rằng bạn nên xuất bản thêm về chủ đề này, nó có thể không là một điều cấm kỵ chủ đề nhưng điển hình mọi người không nói về vấn đề những điều này. Đến phần tiếp theo! Chúc mọi điều tốt đẹp nhất!|Chào bạn! Tôi chỉ muốn cho bạn một rất cho thông tin tuyệt vời bạn có ở đây trên bài đăng này. Tôi đang quay lại trang web của bạn để biết thêm thông tin sớm nhất.|Khi tôi ban đầu để lại bình luận tôi có vẻ như đã nhấp vào hộp kiểm -Thông báo cho tôi khi có bình luận mới- và từ bây giờ mỗi lần được thêm vào tôi nhận được 4 email có cùng nội dung. Có lẽ có một phương pháp dễ dàng bạn có thể xóa tôi khỏi dịch vụ đó không? Cảm ơn bạn.|Lần sau Tôi đọc một blog, Tôi hy vọng rằng nó không thất bại nhiều như bài này. Rốt cuộc, Tôi biết điều đó là sự lựa chọn của tôi để đọc, tuy nhiên tôi thực sự tin bạn sẽ có điều gì đó thú vị để nói về. Tất cả những gì tôi nghe được là một loạt tiếng rên rỉ về điều gì đó mà bạn có thể sửa nếu bạn không quá bận tìm kiếm sự chú ý.|Đúng với bài viết này, tôi thực sự tin trang web này cần nhiều hơn nữa sự chú ý.
{Tôi đã háo hức khám phá trang web tuyệt vời này. Tôi muốn cảm ơn bạn {vì đã|dành thời gian cho|chỉ vì điều này|vì điều này|cho bài đọc tuyệt vời này!! Tôi chắc chắn thưởng thức từng của nó và tôi cũng đã đã lưu vào mục ưa thích để xem những thứ mới trên trang web của bạn.|Tôi có thể chỉ nói rằng thật thoải mái để khám phá một người mà thực sự hiểu họ là gì thảo luận trực tuyến. Bạn chắc chắn nhận ra cách đưa một vấn đề ra ánh sáng và làm cho nó trở nên quan trọng. Nhiều người hơn nữa thực sự cần kiểm tra điều này và hiểu khía cạnh này câu chuyện của bạn. Thật ngạc nhiên bạn không nổi tiếng hơn vì bạn chắc chắn sở hữu món quà.|Tốt bài đăng. Tôi hoàn toàn đánh giá cao trang web này. Tiếp tục với nó!|Thật khó đến những người có hiểu biết sâu rộng về điều này, tuy nhiên, bạn có vẻ bạn biết mình đang nói gì! Cảm ơn|Bạn cần tham gia một cuộc thi dành cho một blog trên mạng có chất lượng cao nhất. Tôi chắc chắn sẽ khuyến nghị trang web này!|Một hấp dẫn đáng giá bình luận. Tôi tin rằng bạn nên viết thêm về chủ đề này, nó có thể không là một điều cấm kỵ chủ đề nhưng nói chung mọi người không nói về chủ đề như vậy. Đến phần tiếp theo! Cảm ơn rất nhiều!|Chào bạn! Tôi chỉ muốn đề nghị rất cho thông tin tuyệt vời bạn có ngay tại đây trên bài đăng này. Tôi sẽ là trở lại trang web của bạn để biết thêm thông tin sớm nhất.|Sau khi tôi ban đầu để lại bình luận tôi có vẻ như đã nhấp vào hộp kiểm -Thông báo cho tôi khi có bình luận mới- và bây giờ mỗi lần được thêm vào tôi nhận được 4 email cùng chính xác một bình luận. Có một cách bạn có thể xóa tôi khỏi dịch vụ đó không? Cảm ơn.|Lần sau Tôi đọc một blog, Tôi hy vọng rằng nó không thất bại nhiều như bài này. Ý tôi là, Tôi biết điều đó là sự lựa chọn của tôi để đọc, nhưng tôi thực sự nghĩ bạn sẽ có điều gì đó thú vị để nói về. Tất cả những gì tôi nghe được là một loạt tiếng rên rỉ về điều gì đó mà bạn có thể sửa nếu bạn không quá bận tìm kiếm sự chú ý.|Đúng với bài viết này, tôi nghiêm túc nghĩ trang web này cần nhiều hơn nữa sự chú ý.
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{Tôi háo hức khám phá trang này. Tôi muốn cảm ơn bạn {vì đã|dành thời gian cho|chỉ vì điều này|vì điều này|cho bài đọc tuyệt vời này!! Tôi chắc chắn yêu thích từng một chút nó và tôi cũng đã lưu làm mục ưa thích để xem những thứ mới trên trang web của bạn.|Tôi có thể chỉ nói rằng thật nhẹ nhõm để tìm thấy một người mà thực sự hiểu họ là gì đang nói về trên internet. Bạn chắc chắn hiểu cách đưa một vấn đề ra ánh sáng và làm cho nó trở nên quan trọng. Nhiều người hơn cần đọc điều này và hiểu khía cạnh này câu chuyện của bạn. Tôi không thể tin bạn không nổi tiếng hơn vì bạn chắc chắn nhất có món quà.|Tốt bài viết trên blog. Tôi chắc chắn yêu thích trang web này. Tiếp tục làm tốt!|Thật khó đến những người có kinh nghiệm trong chủ đề cụ thể này, tuy nhiên, bạn nghe có vẻ bạn biết mình đang nói gì! Cảm ơn|Bạn nên là một phần của một cuộc thi dành cho một trang web trên mạng tuyệt vời nhất. Tôi sẽ khuyến nghị blog này!|Một cuộc thảo luận thú vị đáng giá bình luận. Không còn nghi ngờ gì nữa rằng bạn nên xuất bản thêm về vấn đề này, nó có thể không là một điều cấm kỵ vấn đề nhưng thường xuyên mọi người không thảo luận những chủ đề những điều này. Đến phần tiếp theo! Cảm ơn rất nhiều.|Chào buổi sáng! Tôi chỉ muốn cho bạn một rất to cho thông tin tuyệt vời bạn có ở đây trên bài đăng này. Tôi sẽ là quay lại trang web của bạn để biết thêm thông tin sớm nhất.|Sau khi tôi ban đầu để lại bình luận tôi có vẻ như đã nhấp hộp kiểm -Thông báo cho tôi khi có bình luận mới- và bây giờ bất cứ khi nào có bình luận được thêm vào tôi nhận được 4 email cùng chính xác một bình luận. Phải có một phương pháp dễ dàng bạn có thể xóa tôi khỏi dịch vụ đó không? Cảm ơn rất nhiều.|Lần sau Tôi đọc một blog, Tôi hy vọng rằng nó sẽ không thất bại nhiều như bài này. Rốt cuộc, Tôi biết điều đó là sự lựa chọn của tôi để đọc, dù sao thì tôi thực sự tin bạn sẽ có điều gì đó hữu ích để nói về. Tất cả những gì tôi nghe được là một loạt tiếng rên rỉ về điều gì đó mà bạn có thể sửa nếu bạn không quá bận tìm kiếm sự chú ý.|Đúng với bài viết này, tôi nghiêm túc cảm thấy trang web tuyệt vời này cần nhiều hơn nữa sự chú ý.
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