お盆休み中の方も多いと思いますが、いかがお過ごしですか。
さて今回も、アメリカ食品医薬品局(FDA)がアメリカ国内の製薬会社向けに出したウォーニングレター2件を見ていきたいと思います。FDAがどのような点を問題視して指摘しているかをご確認いただければ幸いです。
最近のウォーニングレターの概要
注：文中のXXはウォーニングレターでマスキングされている文言及び具体的な社名・品名等です。
■CMS#623723■
2021年11月8日～11月11日のカリフォルニア州の製造所の査察でみつかった医薬品製造の重大なCGMP違反について発した2022年4月19日付ウォーニングレターには、下記の指摘事項があげられています。
●指摘１
適切な品質部門の制定を怠り、品質管理部門に適用される責任と手順が文書化・遵守されていなかた。 (21 CFR 211.22(a), 211.22(d))
＜指摘１詳細＞
貴社は、手指消毒剤XXを含むOTCの手指消毒剤を製造している。貴社の品質システムは不十分である。貴社は、貴社のOTC医薬品製造の適切な監督を保証する責任を持った品質部門を制定することを怠っ。
例えば貴社は、品質部門の責任が文書化・遵守されていること、貴社の製品の規格が制定され承認されいること、各ロット及びそれに関連する情報の最終的なレビュがリリース前及び販売前に適切に文書化され完了していることを保証するのを怠った。
全ての製造作業を監督する品質部門は、医薬品の品質を一貫して保証するために必要である。CGMPの件21 CFR 210, 211を満たすための品質システムとリスクマネジメントのアプローチを実装する助けとして、FDAのガイダンス文書を見よ。
●指摘２
貴社は、ロットがサンプリングされ、試験または検査され、品質管理部門により使用のためにリリースするまで、成分、製品の容器、蓋の使用を控えることを怠った。 (21 CFR 211.84(a))
＜指摘２詳細＞
貴社は、手指消毒剤XXの製造で原薬として使用されるエタノールを含む、OTC医薬品の製造で使用される成分をサンプリング、試験、検査することを怠った。査察中、貴社は使用前に入荷した原材料を試験しなかったと述べた。貴社は我々査察官に、貴社の顧客XX側にエタノールを含む原材料を調達する責任があると述べた。しかし、これは貴社が製造で使用する前に、エタノール内のメタノールの存在の試験を含む、品質を保証するための使用前の医薬品の成分のサンプリング、試験、検査をするという製造業者としての責任を免除するものではない。
メタノールで汚染されたエタノールの使用は、世界中の人々の様々な致死的中毒事件をもたらしている。エタノールを含む医薬品を製造する際にCGMP要件を満たすための助けとして、FDAのガイダンス文書Policy for Testing of Alcohol (Ethanol) and Isopropyl Alcohol for Methanol, Including During the Public Health Emergency (COVID-19)を見よ。
●指摘３
貴社は、医薬品の各ロットについて、リリース前に、各有効成分の同一性、濃度を含む、医薬品の最終規格への適合性を判断する適切な試験の判断を行わなかった。 (21 CFR 211.165 (a))
＜指摘３詳細＞
貴社は、エタノールを含むとラベル表示された手指消毒剤XXのロットのリリース試験を実施することを怠った。査察中、貴社は、医薬品のリリース試験は実施されていないと述べた。医薬品は、リリース前に、同一性、濃度、品質、純度に関して試験されなければならない。試験は、貴社が製造した医薬品、微生物の規格を含む、意図した使用目的に適した、全ての予め定義された品質特性に従うことを保証するために不可欠である。
●指摘４
貴社は、製造された医薬品の各ロットの製造と管理に関する情報を含むロットの製造指図記録を作成すことを怠った。(21 CFR 211.188)
＜指摘４詳細＞
貴社は、貴社が製造した手指消毒剤XXのロットの製造実施記録が不足していた。査察中、貴社は製造記録を作成していないと述べた。また貴社は、従業員が手指消毒剤の配合と最終濃度を知っているので、望ましい濃度の最終製品を製造するために毎回同じ方法で製造を行っていると述べた。製造実施記録がなくて、これに限定されないが成分の重量と大きさ、正しい装置の使用、全ての重要な処理パラメータの遵守、歩留まりの記述を含む、バッチ間の均一性を保証するための、医薬品の製造プロセスの各重要なステップが意図した通りに完了したことを検証できない。さらに貴社は、間違いが発生していないかを判断できないし、それらの間違いが製品の品質や患者の安全に影響を与える可能性があるかどうかや、個々のロットへのトレーサビリティを判断することができない。
●医薬品の製造中止
貴社がこの製造所での医薬品の製造を中止すると約束したことを認識している。もし医薬品の製造を再開する計画をする場合は、操業を再開する前に連絡せよ。
●請負業者としての責任
医薬品は、CGMPを遵守して製造されなければならない。FDAは、多数の医薬品製造業者が製造設備、試験機関、包装業者、ラベル貼付業者などの独立した請負業者を使用していることを認識している。FDAは請負業者も製造業者の延長とみなす。
貴社には、製品のオーナーとの契約に関わらず、受託製造所として、貴社が製造する医薬品の品質に責がある。貴社には、医薬品の安全性、同一性、濃度、品質、純度を保証するために、医薬品がFD&C Act 501(a)(2)(B)に従って製造されていることを保証することが求められている。
FDAのガイダンス文書Contract Manufacturing Arrangements for Drugs : Quality Agreementsを見よ。
●CGMPコンサルタントの推奨
貴社がアメリカ市場向けに医薬品の製造を再開するつもりなら、我々は、CGMPの要件を満たすように貴社を支援するために21 CFR 211.34に記載されている適格性のあるコンサルタントを雇うことを強く勧める。
貴社のコンサルタントの使用は、CGMPを順守するための貴社の義務を軽減するものではない。貴社の経営陣には、継続的なCGMP順守を保証するために、全ての不備とシステムの欠陥を解決する責任が残る。
●結論
この文書で挙げた違反は、貴社の施設に存在する違反の包括的なリストではない。貴社には、違反を調査し、原因を判断し、再発やその他の違反の発生を防止する責任がある。全ての違反を速やかに是正せよ。この問題への即座の適切な対処の不履行は、制限のない差し押さえ、強制命令を含む、さらなる通知のない制限または法的なアクションにつながるかもしれない。未解決の違反は、他の連邦機関の契約授与も妨げるかもしれない。
違反への対処の不履行は、FDAの輸出証明の発行の差し控えにもつながるかもしれない。全ての違反に完全に対応がされ、我々が貴社のCGMPの遵守を確認するまで、FDAは貴社の医薬品製造業者としての新し申請やリストの補完の承認を保留するだろう。我々は、貴社が全ての違反に対する是正処置を完了したことを確認するために再査察を行うかもしれない。
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■CMS#623494■
2021年11月1日～11月5日のオハイオ州の受託試験機関の査察でみつかった原薬製造の重大なCGMP違反について発した2022年4月20日付ウォーニングレターには、下記の指摘事項があげられています。
●指摘１
貴社は、不正アクセスやデータの変更を防ぐためのコンピュータ化システムの十分な管理を実施することを怠り、データの削除を防ぐための適切な管理を怠った。
＜指摘１詳細＞
貴社は、貴社の施設で生成されたデータの完全性を保証するための適切な管理を実装することを怠った。貴社は、粗ヘパリンと医薬品有効成分ヘパリンナトリウムのCGMP試験を実施する契約試験機関である。貴社で実施される試験、とりわけ、XXによる元素不純物試験と、XXによる同一性試験を含むヘパリンのXX試験は、死亡を含む有害事象に関係したヘパリンの歴史的汚染の汚染物質である過硫酸コンドロイチン硫酸(OSCS)の存在に関するサンプルの分析を含む。
FDAの査察の開始の直前に、貴社、貴社のヘパリンナトリウムの代理店、USP、顧客は、監査を実施した。XXの試験のローデータのレビュの後、貴社の顧客のリスクアセスメントで、貴社の学生の分析者が、改竄データを持っていたと判断した。貴社及び貴社の顧客の代表は、FDAの査察官に対し、貴社でCGMPの試験をはじめてからXXとXXのローデータがレビュされたのは今回が初めてだったと告げた。XXデータの改竄は、およそ2018年から2020年にかけて発生し、サンプル、スパイク、相関の分析者の任意の値の入力で起きていた。
データの改竄に関する懸念に加えて、次のようなデータ・インテグリティのさらなる懸念が明らかにされた：
・XXの全てのサンプル試験結果が、誰で操作できる制御されていないフォルダに保存されていた。
・装置XXとXXは、教員や大学院生を含む多数の人々により使用されていた。全てのユーザーは、全て の管理アクセスが許可された１つのログインを共有していた。
・CGMPの試験が始まって以来、XXのローデータはバックアップされていなかった。
・XXを実行するソフトウエアには監査証跡がなかった。
・スパイクの回収やXX分析の最終結果を計算するために使用されるエクセルのスプレッドシートは管理 されていなかった。
・装置XXとXXを実行するソフトウエアはバリデートされていなかった。
・貴社は再処理が行われたと述べたが、サンプルの再処理は正式に文書化されていなかった。
・XXの分析において、選択されたスペクトラムのピークが確立された手順で制定された手順で取り扱わ れていなかった。貴社は回答の中で、“データの改竄”は、システムの適合性要件を満たさなかったサンプルの再分析をただ避けたいという1人の分析者に関係していると述べた。また、貴社は、“データの改竄”は規格に準拠した結果を作るために実行されたものではないとも述べた。しかし、我々は貴社の結論には同意しない。へバリンの暴露のリスク評価で特定された全ての原因は、USP(米国薬局方)に従って、完全に定量化される必要がある。報告された原因の最終的な定量的データの不足は、製品が医薬品の品質について適切に分析されていないことを示している。これらのシステムの適合性の不具合は、他の不具合の中でも特に、分析結果の信頼性が低く報告可能でない、または、ヘパリン薬品の品質を裏付けるのに適していないことを示している。従って、生成された分析結果が、規格内なのか不合格なのかを結論づけることが出来ない。
貴社の品質システムは、貴社が顧客のために分析した医薬品の安全性、有効性、品質を裏付けるためのデータの正確性と完全性を適切に保証していない。データ・インテグリティに対応したCGMPに従うために、FDAのガイダンス文書Data Integrity and Compliance With Drug CGMPを見よ。
我々は、貴社の改善を支援するために適格性のあるコンサルタントを雇うことを強く勧める。この文書への回答の中で以下の情報を提供せよ：
Ａ．データの記録及び報告の不正確さの範囲の包括的な調査には以下のことを含むべきである：
・(1)詳細な調査のプロトコルと方法論、(2)アセスメントの対象となる全てのシステムのサマリ、
(3)貴社が除外を提案した操作の正当化
・データの不正確さの性質、範囲、根本原因を特定するための、現在とかつての従業員のインタビュ
我々はこれらのインタビュが、適格性のあるサードパーティによって実施されることを推奨する。
・貴社の施設におけるデータ・インテグリティの不備の範囲のアセスメント
省略、変更、削除、記録の破壊、非同時の記録の完成、その他の不備を特定せよ。貴社が発見した
データ・インテグリティが欠落している貴社施設の全ての作業を述べよ。
・試験データの完全性の不備の性質の包括的で回顧的な評価
我々は、潜在的な違反が確認された分野の専門知識を持った適格性のあるサードパーティが全ての
データ・インテグリティの欠落を評価することを勧める。
Ｂ．貴社が試験した医薬品の品質において発見された不具合の潜在的な影響に関する現在のリスクアセスメント
貴社のアセスメントには、データ・インテグリティの欠落の影響を受けた医薬品の出荷により患者に
引き起こされるリスクの分析と、継続的な作業により引き起こされるリスクの分析を含めるべきである。
Ｃ．グローバルな是正処置・予防処置の計画の詳細を含む、貴社のマネジメント戦略
貴社の戦略には以下のことを含めるべきである。
・分析データ、FDAに提出される全てのデータを含む貴社が生成する全てのデータの信頼性と網羅性を、貴社がどのように保証するかを述べた詳細な是正処置の計画
・現在のアクションプランの範囲と深さが、調査とリスクアセスメントの結果に釣り合うというエビデンスを含むデータ・インテグリティの欠落の根本原因の包括的な記述
データ・インテグリティの欠落の責任がある個人が、貴社でCGMP関連または医薬品の申請のデータに影響を与え得ることができる状態のままかどうかを示せ。
・顧客への通知、追加試験の実施、強化した苦情モニタリングなど、患者を守り、貴社が試験した 医薬品の品質を保証するために、貴社がとった、または、とろうとしているアクションを述べた
暫定的な手段
・貴社のデータの完全性を保証するために設計された手順、プロセス、方法、管理、システム、監督、
人的資源（例：教育、職員の改善）に対する改善努力と強化を述べた長期の手段
・既に進行中または完了した上記の全ての活動に関する状況報告
さらに、次の情報を提供せよ：
・文書化手順が不十分な場所を判断するための、貴社の試験業務全体で使用されている文書化システムの完全なアセスメント
貴社の業務を通して、帰属可能で、判読可能で、完全で、原本性があり、正確で、同時性のある記録を保持していることを保証するために、貴社の文書化手順を包括的に改善する詳細なCAPAの計画を含めよ。
ヘパリンに関する更なる参考文献として、業界のガイダンス文書
Heparin for Drug and Medical Device Use : Monitoring Crude Heparin for Qualityを見よ。
●指摘２
貴社の品質部門は、医薬品が適切に試験されその結果は報告されていることを保証することを怠った。
＜指摘２詳細＞
貴社は、試験業務を適切に監督するための適切な品質部門(QU)または品質システムを持っていなかった。FDAが、貴社がFDAの査察の準備が出来ているかをたずねる連絡を取る前、貴社は手順を整備しておらず、貴社で実施されるCGMPの試験を監督する、確立されたQUを持っていなかった。さらに、査察の過程でFDAの査察官は、貴社で最も責任のある主任研究者がFDAの査察の初日に変更されたと知らされた。前の主任研究者は、今はコンサルタントである。
適切なQUや品質システムもなしに、貴社のCGMPの試験作業を管理された状態で確実に実施するための管理が実施されているという十分な保証がない。
貴社は、貴社がFDAの査察の準備ができているかFDAにたずねられた後、適用される要件に準拠するために非常に短い時間で品質システムとそれに対応する手順を作成しようと試みたようだ。貴社は回答文書の中や査察の中で、CAPAのポリシー、根本原因の分析、品質システムのマニュアルを含む最近作成した20以上の手順を提供した。しかし、これらの全ての手順は、FDAの最初の連絡の後に作成されただけでなく、州際通商へ医薬品のリリースを含むCGMPの目的で使用される試験結果を提供した後にも作成された。
さまざまな手順は、査察中や貴社の回答文書の中で提出されたが、機能するために十分な詳細さに欠けていると思われる。さらに貴社は、貴社が手順を適切に実装し、遵守していることを示す証拠を提供しなかった。
この文書への回答の中で、以下の情報を提供せよ：
・貴社のQUが効果的に機能するための権限とリソースが与えられていることを保証するための包括的な アセスメントと改善の計画 アセスメントには、これに限定されないが、以下のことを含めるべきである：
〇貴社で使用されている手順が安定していて適切であるかどうかの判断
〇適切な手順の遵守を評価するための貴社の作業全体のQUの監督の規定
〇QUの出荷判定前の、各ロットとそれに関連する情報の完全で最終的なレビュ
〇全ての製品の同一性、濃度、品質、純度を保証するための調査の監督と承認及びその他のQUの職務の遂行
●指摘３
教育が適格な個人により定期的に実施され、少なくとも、各職員が実施する特定の業務と業務に関係するCGMPが対象とされていることを保証することを怠った。
＜指摘３詳細＞
貴社は、CGMPの試験を実施する試験担当者が、現在のGMPの要件について適切に訓練されていることを保証することを怠った。CGMPの試験は、貴社で教員と大学院生により実施されている。貴社には試験担当者がそれぞれの業務について適切に訓練されていることを示すための適切な文書が不足していた。
貴社は回答文書の中や査察の中で、我々が事前にアナウンスした査察を開始する約1週間前に作った“GMPと教育”、“従業員の教育”というタイトルの教育手順を提出した。貴社は、手順を作る前にCGMPの試験を始め、貴社の顧客に提供される試験結果を裏付けるために試験担当者が専門知識を持っているか教育を受けていることを示すために以前の試験担当者の回顧的なアセスメントを実施することを怠っているので、貴社の回答は不十分である。
この文書への回答の中で、以下の情報を提供せよ：
・貴社の試験業務、手順、方法、装置、文書、分析者の能力の包括的で独立したアセスメント
このレビュに基づき、貴社の試験システムを改善し、試験システムの効果を評価するための詳細な計画を提出せよ。
・以前の試験担当者が適切にCGMPの試験を実施するための専門知識を持っていたことを示すための回顧的なアセスメント
このアセスメントの時間枠は、使用期限内の全ての医薬品のCGMP試験を含むことを保証するべきである。
●CGMPコンサルタントの推奨
我々が貴社で確認した逸脱の性質に基づき、我々は、CGMPの要件を満たすように貴社を支援するために貴社の業務を評価する適格性のあるコンサルタントを雇うことを強く勧める。貴社のコンサルタントの使用は、CGMPを順守するための貴社の義務を軽減するものではない。貴社の経営陣には、継続的なCGMP順守を保証するために、全ての不備とシステムの欠陥を解決する責任が残る。
● 中止/停止した原薬試験
我々は貴社が、貴社の施設で、原薬の微量金属の分析を中止し、XX試験業務を停止したと認識している、この文書への回答の中で、貴社が今後この施設で医薬品の試験を再開するつもりか明確にせよ。もしCGMPの試験を再開することを計画するなら、業務を再開する前に連絡せよ。
●結論
この文書で挙げた逸脱は、貴社の施設に存在する逸脱の包括的なリストではない。貴社には、逸脱を調査し、原因を判断し、再発やその他の逸脱の発生を防止する責任がある。
全ての逸脱を速やかに是正せよ。この問題への即座の適切な対処の不履行は、制限のない差し押さえ、強制命令を含む、さらなる通知のない制限または法的なアクションにつながるかもしれない。未解決の逸脱は、他の連邦機関の契約授与も妨げるかもしれない。
逸脱への対処の不履行は、FDAの輸出証明の発行の差し控えにもつながるかもしれない。全ての逸脱に
完全に対応がされ、我々が貴社のCGMPの遵守を確認するまで、FDAは貴社の医薬品製造業者としての新しい申請やリストの補完の承認を保留するだろう。我々は、貴社が全ての逸脱に対する是正処置を完了したことを確認するために再査察を行うかもしれない。
まとめ
いかがでしたでしょうか。
1件目のレターには、リリース前に試験を実施していない、製造記録を作成していないといった、びっくりするような内容が含まれていました。新型コロナのもとで無理をして手指消毒剤を製造しようとしたという背景があるのかもしれません。
2件目のレターは、データ・インテグリティに関連した指摘が含まれていました。
・データを保存するフォルダのアクセス制限がされていない
・管理者権限を持ったログインIDを複数の人間が使いまわしている
・データをバックアップしていない
・監査証跡がない
・エクセルシートが管理されていない
・ソフトウエアがバリデートされていないといった、身近な内容の指摘だったので、是非参考にしてみていただければと思います。
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【発行責任者】
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