今年も残すところ約2週間となりましたが、いかがお過ごしですか？
海外の製造所向けウォーニングレターは、未だに除菌用ローションのエタノールの含有量に関する指摘が多いため、今回も、アメリカ国内の製薬会社向けに出されたFDAのウォーニングレターを２件取り上げたいと思います。
アメリカ国内向けとは言え、データ・インテグリティの不備等の指摘内容は参考になるものなので、是非お読み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。
■WL#614644■
2021年3月8日～3月23日のカリフォルニア州の処方薬・OTC薬・原薬の受託試験機関の査察でみつかったCGMP違反について発した2021年8月17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、権限のある職員のみが製造指図記録、または、その他の記録の変更を開始することを確実にするためにコンピュータ及び関連システムの適切な管理を実施することを怠った。
＜指摘１詳細＞
貴社は、リリース前の製品を試験するのに使用されるガス・クロマトグラフィー(GC)のデータ収集システムの管理が不足していた。特に、貴社のGC(GC-XXとGC-XX)のデータ収集システムは、ローデータのファイルの削除または変更を防ぐための十分な管理がされていなかった。査察中、我々査察官は、医薬品の分析を行っている試験職員がGC装置のオペレーティング・ソフトウエアXXに対する管理者権限を持っていることを発見した。管理者権限は、これに限定されないが、データ・シーケンスの削除、方法の変更/削除、方法、監査証跡の無効化/有効化ができる権限を含んでいた。
さらに、少なくとも2018年4月から2021年2月まで、高速液体クロマトグラフィー(HPLC)とGCは、各分析試験に関する情報を記録するための下記のような監査証跡を有効化していない状態で操作されていたことがわかった：
- 注入タイプ
- 日付と時間
- 分析者のID
- 取られたアクションの理由(例：記録の修正)
貴社は、微生物の負荷試験のために試験職員により使用される電子的ワークシートをバリデートすることも怠っていた。レビュされた微生物ワークシートは、負の対数の換算や、黄色ブドウ球菌、緑膿菌に関するXX％とXX%の減少率などの誤ったデータ生成につながる、バリデートされていないセルの計算式が使われていることがわかった。これらのバリデートされていない計算は、これらのスプレッドシートで生成されたデータの正当性に疑問を生じさせる。
我々は、2018年4月に、貴社の所有者が変わり、新しい組織構成が実装され、新しい職員がアサインされたことを知っている。しかし、これは、FDAが同様のCGMP違反で指摘した以前のウォーニングレター(2016年8月2日付WT#38-16)で貴社の製造所で発見した違反の繰り返しである。前の経営陣は、ウォーニングレターに対する回答として、2016年8月22日に、その違反に関する具体的な改善を提案していた。しかし、繰り返される不具合と適切な管理の実施の遅れは、経営陣の試験作業に対する監督・管理が不十分なままであることを示している。我々は、貴社がヒト用医薬品と原薬の両方を試験するのに同じプロセスを使用していることも指摘している。
貴社は回答の中で、分析を行う職員について、管理者権限XXをやめる、分析者の権限に変えることを約束した。しかし、追加の対応で提出された裏付け文書は、貴社が約束した適切な管理を実装していなかったことを示している。特に、ユーザは不適切な管理者権限を持ち続けている。
貴社の顧客は、医薬品の品質に関する判断をするために貴社が生成した試験データの完全性を信頼している。全ての試験データが保持され、貴社の電子記録内の情報の追加、削除または修正は、許可され適切に文書化されていることを保証するために、CGMPの電子データの厳格な管理を維持することが重要である。
さらに、貴社は、今後の試験分析について、監査証跡の一部のみのXXのレビュを実施すると約束した。
21 CFR 211.22は、バッチリリースの前に、監査証跡データを含むデータのレビュを求めているので、貴社の回答は不適切である。この文書への回答の中で以下の情報を提供せよ：
- 監査証跡を有効にしている全ての試験器具とソフトウエアのリスト
- 全ての分析者と適用可能な電子試験装置のオペレーティング・ソフトウエアについて貴社が是正したと述べた、GC-XXとGC-XXに関する特定の職員のデータ権限についての構成変更を検証する文書
- 全てのソフトウエアの構成（装置のソフトウエアと試験情報システム（LIMS）の両方）のリスト、管理者権限を含む全てのユーザの権限の詳細と、貴社の各試験システムの監督の役割のリスト
ユーザの権限について、試験室のコンピュータシステムにアクセスできる全ての職員のレベルについて、ユーザの役割と権限と、それらの組織の所属と肩書を明記せよ。管理者権限が完全に分離され、品質部門の職員と独立していることを貴社がいかに保証するつもりかの詳細を述べよ。 - 貴社の暫定的な管理と、全ての適用可能な試験装置と電子データシステムの監査証跡が有効化される時期と、CGMPの対象となる分析結果のリリース前の監査証跡のレビュに関する手順が実装される時期を述べた貴社のタイムライン付のアクションプラン
- 貴社の試験装置と電子システムデータの監査証跡を有効化しなかったことと、この再発する不具合が生成されたデータに与えた影響に関する調査
●指摘２
貴社は、必要とされる試験管理のしくみを制定し、従うことを怠った。
＜指摘２詳細＞
貴社は、品質部門の文書化・アセスメント・承認により、電子の試験モニタリング作業への重大な変更を適切に管理することを怠った。特に、品質部門の監督のない試験作業への重大な変更には、これに限定されないが、以下のことを含んでいた：
- 規格や試薬の追跡、モニタリングのための電子ワークシートの実装
- 分析者のIDが付いた、事前に用意された微生物試験のワークシートへの変更
- 管理手順や変更管理もなく、2021年2月16日に装置のソフトウエアの監査証跡の活性化
貴社は回答の中で、変更管理フォーム(PAR A-0037)と、試験作業の変更管理を規定した文書化された手順を改訂することを約束した。貴社は、我々がレビュするためのPAR A-0037と改訂された標準操作手順書のコピーを提供しなかったので、貴社の回答の適切性を判断できなかった。さらに貴社は、貴社の作業に実施された変更とCGMPの対象となる医薬品の分析への影響のシステム的な回顧的レビュを約束することを怠った。
この文書への回答の中で以下の情報を提供せよ：
貴社の変更管理システムの包括的で独立したアセスメント
このアセスメントは、これに限定されないが、変更が正当化され、レビュされ、品質保証部門により承認されていることを保証するための手順を含めよ。貴社の変更管理プログラムには、変更の効果を判断するための規定を含めるべきである。
●データ・インテグリティの改善
貴社の品質システムは、貴社が試験した医薬品の安全性、効果、品質を裏付けるデータの正確性・完全性を適切に保証していない。CGMPに従ったデータ・インテグリティの手順を制定して遵守するためのガイダンスとして、FDAのガイダンス文書Data Integrity and Compliance With Drug CGMPを見よ。
我々は、貴社の改善を助ける適格な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．アメリカ国内に出荷された医薬品に関するデータのレビュ結果を含む、データの記録と報告の不正確性の範囲の包括的な調査
貴社のデータの完全性の欠落の範囲と根本原因の詳細な記述を含めよ。
Ｂ．発見された不具合の貴社の医薬品の品質への影響の可能性に関する現在のリスクのアセスメント
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薬の出荷により引き起こされた患者のリスクと、継続的な作業によるリスクの分析を含めるべきである。
Ｃ．全体的な是正処置及び予防処置の計画の詳細を含む貴社の管理の戦略
是正処置の詳細な計画では、微生物及び分析のデータ、試験記録、FDAに提出された全てのデータを含む貴社が生成した全てのデータの信頼性と網羅性を保証するために貴社がどのようにするつもりかを述べるべきである。
●受託試験機関の責任
FDAは、受託業者を製造業者自身の製造所の延長とみなす。貴社のCGMPの不順守は、貴社の顧客のために貴社が試験した医薬品の品質、安全性、効果に影響を与える可能性がある。CGMPを完全に順守して作業をする責任を理解し、これらの医薬品の試験中に遭遇した規格外の結果や重大な問題を全ての顧客に通知することが重要である。更なる情報については、FDAのガイダンス：Industry Contract Manufacturing Arrangements for Drugs : Quality Agreementsを参照せよ。
●CGMPコンサルタントの推奨
貴社は、繰り返しの違反の是正を怠ったので、我々は貴社がCGMP要件を満たす手伝いをする適格な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、貴社の製造所に存在する逸脱の包括的なリストでもない。貴社には、これらの違反を調査し、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、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は貴社の受託試験機関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#615098■
2021年4月13日～4月26日のミシシッピ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2021年9月21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
貴社の品質管理部門は、貴社で製造された医薬品がCGMPを順守し、同一性、濃度、品質、純度に関して制定された規格を満たすことを保証する責任を果たすことを怠った。
＜指摘１詳細＞
貴社は、貴社の医薬品の製造、包装、出荷のために、貴社の代わりに使用されている受託製造機関(CMO)を管理するための適切な監督と手順に欠けていた。貴社は貴社が実施するCGMP活動について最終的に責任がある。
貴社は、貴社の制定した品質部門(QU)の手順や、品質協定で文書化された義務に従うことを怠った。
貴社は回答の中で、これに限定されないが、貴社の品質部門に関する文書化された手順を持つこと、消費者の苦情の処理をすること、医薬品を出荷すること、貴社のCMOの適格性を評価し承認することを含むCGMPの責任を持っているという姿勢を継続した。品質部門の不備は以下の通りである：
■貴社のCMOの不十分なQUの監督
貴社のQUは、CMOの適切な監督、管理に欠け、基準を満たさないCMOの使用につながった。2017年以来、FDAは、貴社のCMOでみつかったCGMP違反に対応して、以下のアクションをとった。
例えば、XX日付でXX社にウォーニングレターが発行された。そこには、これに限定されないが、製造の各段階の適切なタイムリミットの制定の不履行や、規格外(OOS)の結果の徹底的な調査の不履行を含んでいた。
貴社は回答の中で、貴社のCMに関する承認プロセスに対応する手順を開発中であると述べた。
貴社は、QUの、貴社のCMOに対する監督と、貴社の医薬品の同一性、濃度、品質、純度の影響を受けた可能性のある製品出荷に対する監督の欠如の回顧的なレビュを実施しなかったので、貴社の回答は不十分である。
この文書への回答の中で、供給者が適切に適格性を評価され、適切な監督が維持されていることを保証するための包括的なアセスメントの計画を提出せよ。このアセスメントには、これに限定されませんが、以下の情報を含めるべきである：
- 貴社の代わりに実施するCMOのCGMP活動の全ての機能を網羅した、供給者の適格性の選択範囲と管理の手順
- 貴社の供給者の適格性と、貴社の再適格性評価プログラム(例：監査)の重要な要素
■QU手順の制定と順守の不履行
□バッチリリース手順の欠如
貴社は貴社のCMOによって製造されたロットのレビュに関する、適切に文書化された責任と手順の制定を怠った。貴社は、XXと共にQAによる各ロットの処遇(却下または承認)に関する製造記録のレビュも怠った。
貴社は契約製造所で貴社のために製造された医薬品のロットを承認または却下する最終的な責任を負う。
リリースのための各ロットの適合性を判断することは、貴社の品質部門の責任の重要な要素である。
貴社は回答の中で、CMOからの医薬品のリリースについて明記した文書化された手順がないことを認め、手順を開発中であると述べた。貴社はこれらの手順が何を含み、それらがどのように適用される予定であるかの詳細を提出しなかったので、貴社の回答は不十分である。
□変更管理手順の不順守
貴社のQUは、貴社が変更管理手順に従っていることを保証することを怠った。例えば、2019年3月の前回のFDAの査察以降、貴社は、貴社の変更管理手順に従わずに、消費者の苦情や医薬品の回収の手順の変更を実施した。さらに、変更管理手順に従わずに製品のラベリングに対する変更を承認した。
これらの各事象において、貴社は、貴社の変更管理手順で求められた通りにこれらの変更の正当化や文書化をしなかった。
貴社は回答の中で、貴社が実施した変更について、貴社の変更管理手順に従っていなかったことを認めた。提出されたフォームは、ラベルの材質の変更を含む変更の影響のアセスメントを含んでいなかったので、貴社の回答は不十分である。
この文書への回答で、貴社の変更管理システムの包括的で独立したアセスメントを含めよ。このアセスメントには、これに限定されないが、変更が正当化され、レビュされ、貴社の品質部門により承認されていることを保証するための手順を含めるべきである。貴社の変更管理プログラムは、変更の有効性の判断のための規定も含めるべきである。
貴社は、貴社の医薬品の同一性、濃度、品質、純度に影響を与える可能性があるQUの手順の制定及び順守の不履行の回顧的なレビュを実施しなかったので、貴社の回答は不十分である。
この文書への回答の中で、貴社のQUが効果的に機能するために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計画を提出せよ。アセスメントには、これに限らないが以下のことを含めるべきである：
- 貴社で使用されている手順が安定していた適切かどうかの判断
- 適切な手順の順守を評価するための、貴社の作業全体のQUの監督に関する規定
- QUの出荷判定の前の各ロットの完全で最終的なレビュとそれに関連する情報
アメリカ市場にあり、この文書の日付時点で使用期限内にある全てのロットの回顧的なレビュと、分析でみつかったことをまとめたレポートを含めよ。 - 全ての製品の同一性、濃度、品質、純度を保証するための、QUの調査の監督・承認、及び、QUのその他の職務からの解放
●指摘２
貴社は、製品に関する全ての書面及び口頭の苦情の取り扱いについて述べた適切な文書化された手順を制定しそれを順守することを怠った。
＜指摘２詳細＞
貴社は、貴社の代わりにCMOを使用する際、これに限らないが、消費者の苦情や問い合わせの取り扱いを含む、関連するCGMPの責任があることを認めている。しかし貴社は、苦情の取り扱い手順を適切に制定し、それを順守することを怠った。例えば、貴社の手順は、貴社の”医薬品安全性スペシャリスト“と”最高科学責任者“に対して顧客の苦情の取り扱いと調査に関する責任を規定した。調査中、これらの肩書と職員のポジションは貴社に存在しなかった。
さらに、XXを持つ貴社のQAは、フィールドアラートや回収が発生する可能性がある苦情をXXに通知し、XXは苦情調査を実施し完了する予定であると述べた。全ての品質関連の苦情は、それらの域を超えて、211.198に従い調査されるべきである。
貴社は回答の中で、存在しない肩書を削除し、これらの役職を”最高執行責任者“に置き換えるために、苦情取り扱い手順を改訂したと述べた。貴社は、この個人が、苦情取り扱い手順に従い、苦情が重大で予期しない医薬品の有害事象を示しているかどうかを判断するためのレビュを実施することを示すエビデンスを提出しなかったので、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：
- 貴社が受け取り、貴社のCMOに共有されている、または、共有されているはずの、フィールドアラートや回収につながらない可能性のある品質関連の内容を含む、苦情に関する回顧的なアセスメント
- 貴社のCMOが受け取ったものも含む、全ての情報源から受け取った苦情のリスト
- 品質関連の苦情を貴社のCMOとどのように共有するつもりかの詳細を示した手順
●指摘３
貴社は、正しいラベル、ラベリング、包装が貴社の医薬品のために使用されていることを保証するために設計し文書化された手順を制定しそれを順守することを怠った。
＜指摘３詳細＞
貴社は、貴社のCMOで製造された製品のためのラベリングをレビュし承認しているが、ラベルのレビュと承認に関する貴社の手順は不十分である。例えば、貴社の手順は、保管条件や分注量などのラベルの全ての要素の検証を求めていない。さらに、貴社の手順は、レビュ、または、承認されたマスタまたは参照ラベルとの比較を含んでいない。
貴社は回答の中で、マスタラベルを使用していて、2021年7月1日までにラベルのレビュ手順を改訂している最中であると述べた。貴社の回答は不十分である。
貴社は、貴社が医薬品のラベルのレビュや承認をする際にマスタまたは参照ラベルを使用しているというエビデンスを提出しなかった。さらに、貴社は、この所見に対する回答の中で、改訂された手順を提出していない。さらに、貴社の回答は、適切なラベリングが、現在販売中の全ての製品にされていることを保証するための回顧的レビュに欠けている。
この文書への回答の中で以下の情報を提供せよ：
- ラベリングのレビュと承認、管理監督、その他の必要とされるアクションのための適切な手順を含むラベル作業を改善するための貴社の是正処置・予防処置（CAPA）の計画
- 文書化手順が不十分かどうかを判断するための、貴社の製造及び試験作業を通して使用されている文書化システムの完全なアセスメント
貴社が作業を通して、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。
●製造所での繰り返しの違反
2015年8月、2019年3月の査察で、FDAは同様の所見を挙げた。貴社は回答の中で、これらの所見についての具体的な改善を提案した。これらの繰り返される違反は、貴社の経営陣が医薬品の製造の適切な監督と管理の実施の不履行を示している。貴社はシステム、手順、最終的に製品がFDAの要求に従っていることを保証するために、貴社の全ての製造作業をすぐに包括的に評価すべきである。
この文書への回答の中で、以下の情報を提出せよ：
- これに限定されないが、継続的な管理状態を保証するために、新たに発生した製造/品質の問題に積極的に対応するためのタイムリーなリソースの提供を含む、経営陣がいかに品質保証と信頼できる作業をサポートするか述べよ。
- 貴社のCAPAプログラムの独立したアセスメントと改善の計画
適切な調査能力を持つ職員を評価し、根本原因の分析を効果的に実施し、CAPAの効果を保証し、定期的に調査の傾向をレビュし、必要に応じてCAPAプログラムの改善を実施し、適切な品質部門の決定権を保証し、経営陣により完全にサポートされた報告書を提出せよ。
●契約製造業者の使用
医薬品はCGMPに従っ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は、製造設備、試験機関、包装業者、ラベル貼付業者のような独立した受託業者を使用していることを認識している。FDAは、受託業者を製造業者の延長とみなす。
貴社が回答で述べたように、貴社のCMOのXXが貴社のために製造された医薬品の全てのロットについて微生物試験を実施していることを確認せよ。
受託製造所との契約に関わらず、貴社は貴社の医薬品の品質に責任がある。貴社は、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必要がある。
FDAのガイダンス文書：Contract Manufacturing Arrangements for Drugs : Quality Agreementsを見よ。
●結論
この文書で挙げた違反は、貴社の製造所に存在する逸脱の包括的なリストでもない。貴社には、これらの違反を調査し、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、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は貴社の受託試験機関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。
まとめ
いかがでしたでしょうか。
データ・インテグリティの不備、委託先の不十分な管理は、非常に身近な内容だったと思います。
皆様の業務の参考にしていただければ幸いです。
さて、今年も1年間、ASTROM通信をお読みいただきましてありがとうございました。
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