【最近のウォーニングレター】ASTROM通信 240号

寒暖の差が激しいですが、いかがお過ごしですか。

さて今回は、FDAがアメリカ国外の製薬会社向けに出したウォーニングレター1件と、国内の製薬会社向けに出したウォーニングレター1件を、FDAがどのような点を指摘したかを確認していきたいと思います。
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。

■Warning Letter 320-22-12■

ポーランドの製薬会社に対しFDAが2021年6月2日に記録及びその他の情報提供を依頼し、製薬会社から提出された記録のレビュでみつかった重大なCGMP違反について発せられた2022年3月14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

貴社は貴社が製造する医薬品が、それが持つとされる、または、持つと表示されている同一性、濃度、品質、純度を持っていることを保証するために設計された製造・工程の管理のための文書化された手順を制定し、それに従うことを怠った。
＜指摘１詳細＞
貴社は、貴社の製造工程が、それが持つとされる品質と安全性を持ったホメオパシー薬品を製造できることを証明するための適切なプロセスバリデーションのデータなしに、アメリカにホメオパシー薬品のクリームXXを販売した。
具体的には、貴社が提出した文書は、貴社が製造する医薬品がラベルに記載された濃度であることを裏付けるものでない。製造記録及びXXの製品ラベルのレビュによれば、有効成分XXの濃度はXX％で、およそXXとXXの間である。しかし、貴社が販売した製品のラベルはXXとなっている。これは、貴社が、希釈物内でXXの差がある医薬品を製造しているか、または、活性濃度がラベルに表示されたものの100,000,000倍であることを意味している。
さらに、XXのバリデーションプロトコルとバリデーション報告に関する我々の最初のリクエストに対し、貴社はバリデーションプロトコルは存在しないと回答した。また、貴社が提出した文書は、成分XXについて、製造記録に記録された温度(XX℃～XX℃)と、製造指図書内に記載されている温度範囲(XX℃～XX℃)との間に矛盾があることを示している。
製造工程の各重要な手順は、中間材料と最終製品がその品質特性と規格を満たすことを保証するためにコントロールされていなければならない。バリデートされていない製造工程は、貴社の製品の濃度、品質、純度が変化する可能性を増す。貴社の医薬品製造工程のバリデートの不履行は、貴社の最終製品の有効成分がばらつく可能性があり、一貫性を保証できないことを意味している。
この文書への回答の中で以下の情報を提供せよ：

  • 製品のライフサイクルを通して管理状態を保証するための、関連手順も添えたバリデーションプログラムの詳細なサマリ
    工程の性能適格性評価(PPQ)と、継続的な管理状態を保証するためのロット内及びロット間のばらつきの継続的なモニタリングに関する貴社のプログラムについて述べよ。
  • 販売されている貴社の各医薬品の適切なPPQの実施に関するタイムライン
  • 装置及び設備の適格性評価に関する貴社の工程性能プロトコルと文書化された手順
  • 継続的な管理状態を保証するためのロット内及びロット間の慎重なモニタリングを含む、貴社の各製造工程の設計、バリデーション、維持、管理、モニタリングに関する詳細なプログラム
    装置及び設備の適格性評価のためのプログラムも含めよ。
  • ラベルに表示された内容が正確で、有効成分の濃度が一致していて、正しい桁数を示していることを保証するための、各製品の工程のアセスメント

●指摘２

貴社は医薬品の各成分の同一性を検証するために少なくとも１つのテストを実施することを怠った。
＜指摘２詳細＞
貴社が提出した記録及び情報は、貴社は医薬品の各成分の同一性を検証するために少なくとも1つのテストを実施していることを示していなかった。
例えば、成分の各ロットの同一性試験の情報に関する我々の最初のリクエストに対する貴社の回答は、官能試験を実施しているか、供給者により提供された分析証明書(COA)に頼っていることを示している。
提出された文書は、貴社が、入荷した原材料について、特定の同一性試験を実施していないことを示している。
貴社は、もし医薬品の製造に使用する前に各成分のロットの同一性を検証するために少なくとも1つのテストを実施し、供給者の試験結果に関する適切なバリデーションを通して供給者の分析の信頼性を確証するなら、品質特性について供給者のCOAを信頼することができる。
我々のリクエストの前後にアメリカに輸入された全ての医薬品について、この文書への回答の中で以下の情報を提出せよ：

  • 製造に使用する目的で、入荷した成分の各ロットのテストとリリースのために貴社が使用している、化学及び微生物学上の品質管理の規格
  • 各成分のロットが、同一性、濃度、品質、純度に関する全ての規格に一致することを、貴社がいかにテストするつもりかの記述
    もし貴社が各成分のロットの濃度、品質、純度に関するテストを実施する代わりに供給者のCOAの結果を受け入れるつもりなら、初期のバリデーションと定期的な再バリデーションを通じて供給者の結果の信頼性をいかに慎重に確証するつもりかを明記せよ。さらに、入荷した成分の各ロットについて少なくとも1つの特定の同一性試験を常に実施するという約束を含めよ。
  • 各成分の製造業者から得たCOAの信頼性を評価するための、全ての成分の試験から得られた結果のサマリ
    このCOAのバリデーションプログラムを述べた貴社の標準操作手順を含めよ。
  • 貴社が製造した医薬品の試験をする契約施設の適格性評価と監督に関する貴社のプログラムのサマリ
  • 成分、容器、蓋の全ての供給者がそれぞれ適格性評価をされていて、原材料は適切な使用期限またはリテストの日付が付与されているかどうかを判断するための、貴社の原材料システムの包括的で独立したレビュ
    レビュは、不適切な成分、容器、蓋の使用を防ぐために入荷した原材料の管理が適切かどうかの判断も含めるべきである。
  • 正しい有効成分が使用されていることを判断するための、貴社の医薬品の処方、製品ラベル、製造記録の包括的なレビュ

●指摘３

貴社は、各医薬品のロットの製造、加工、包装、保持の各重要な手順の実施記録を含む、製造指図記録書を作成することを怠った。
＜指摘３詳細＞
我々の記録のリクエストに応じて貴社が提出したバッチレコードは、これに限定されないが、医薬品の製造作業における、主要な装置の同一性、各重要手順の実施時間、ロットの製造の合計時間、各重要手順を実施した職員の特定を含む製造の詳細が不足していた。この文書は、製造工程が一貫して手順を順守し、再現可能であることを確証するために必要である。不完全な記録は、調査のために必要なアクションのトレーサビリティを奪う。
この文書への回答の中で以下の情報を提供せよ：

  • 貴社の医薬品の重要なバリデートされた各製造手順を完全に記録していることを示すための、製造指図記録書の原本
  • 文書化手順の不十分な場所を特定するための、貴社が製造作業を通じて使用し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。

●指摘４

貴社は、成分、製品の容器、蓋、工程内原料、ラベル、製品が同一性、濃度、品質、純度の適切な標準に一致していることを保証するために設計された、科学的に正当で適切な規格、標準、サンプリング計画、試験手順を含む試験室の管理を制定することを怠った。
＜指摘４詳細＞
アメリカに出荷したロットに関して貴社が提出したCOAのレビュで、貴社がXXの微生物試験に関する適切な規格を制定することを怠っていたことが判明した。貴社のCOAは、アメリカ薬局方の一般章<61>「非滅菌製品の微生物試験」またはそれと同等のバリデートされた方法に従って、好気性菌の総菌数に関する試験をしていることを示していない。さらに、COA内で規定されている酵母とカビに関するXX CFU/gの上限に関する正当性はない。21 CFR 211.160(b)のもとで、試験の管理には、最終製品が同一性、濃度、品質、純度の適切な規格に従うことを保証するために、科学的に妥当で適切な規格の制定が含まれなければならない。製品のラベルにはXXの使用を示しているので、好気性菌の総菌数や、酵母とカビの数に関する科学的に妥当で適切な規格を制定することが重要である。
この文書への回答の中で、以下の情報を提供せよ：

  • 最終製品試験の妥当性を保証するための包括的で独立したアセスメントとCAPAの計画
    貴社の改善されたプログラムには、これに限定されないが、USP抄録モノグラフの規格を使用するというコミットメントも含めるべきである。
  • ロットの処遇の判断する前に貴社の製品の各ロットを分析するために使用される試験方法を含む、微生物の規格のリスト
    • この文書の日付時点で使用期限内にあるアメリカに出荷された製品の全てのロットの品質を判断するための、全ての保管サンプルの微生物試験の実施に関するアクションプランとタイムライン
    • 各ロットの保管サンプルの試験から得られた全ての結果のサマリ
      もしそれらの試験で、基準を満たしていない品質の製品が明らかになった場合、顧客への通知や製品の回収のような迅速な是正処置をとれ。
  • 貴社の試験の業務、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の改善と効果の評価の詳細な計画を提出せよ。

●プロセスバリデーション

貴社にはプロセスバリデーションプログラムがない。プロセスバリデーションは、そのライフサイクルを通じて工程の設計と管理状態の正当性を評価するものである。製造工程の各重要な手順は、適切に設計され、投入する原材料、工程内原料、最終製品の品質を保証しなければならない。工程の適格性評価は、初期の管理状態が確立されているかどうかを判断する。
商用の出荷の前に、工程の適格性評価を成功させる必要がある。その後、製品のライフサイクルを通じて貴社が安定した製造作業を維持していることを保証するために、工程の性能と製品の品質の継続的で慎重な監視が必要である。

●プロセス管理

貴社は、安定した製造作業と一貫した製品品質を保証するための工程管理のモニタリングに関する適切で継続的なプログラムを持っていない。
FDAがプロセスバリデーションの適切な要素と考える一般原則とアプローチに関し、FDAのガイダンス文書Process Validation : General Principlesを見よ。

●CGMPコンサルタントの推奨

我々が貴社で発見した違反の性質に基づき、もし貴社がアメリカ市場向け医薬品の製造を続けるつもりであれば、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に規定された適格性のあるコンサルタントを雇うことを強く勧める。また我々は、貴社がFDAと共に貴社のコンプライアンス状態の解決を達成しようとする前に、適格なコンサルタントが貴社のCGMP遵守に関し貴社の全ての作業の包括的な監査を実施し、貴社の是正処置・予防処置の完了と効果を評価することを勧める。
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違反の包括的なリストでもない。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。
FDAは2022年3月4日に輸入警告措置66-40をとった。全ての逸脱に完全に対応され、我々が貴社のCGMPの遵守を確認するまで、FDAは貴社の製造業者としての新薬の申請やリストの補完の承認を保留するだろう。

出典：https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/dr-retter-ec-wladyslaw-retter-619881-03142022

～～～～～～～～～～～～～～～～～～～～～～～～～～～～～～～～～～～～～～～～

■CMS#619450■

2021年8月24日～8月31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2月24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、そのロットが既に出荷されたかどうかに関わらず、その規格を満たすために、ロットまたはその成分の説明のつかない不一致や不具合を徹底的に調査することを怠った。
＜指摘１詳細＞
貴社は規格外(OOS)を適切に調査しなかった。具体的には、貴社は分析でOOSの結果になった複数のOTC医薬品のサンプルの新しい試験標本を準備した。オリジナルの試験結果を確認するために最初に不合格になった結果の適切な調査をせずにOTC医薬品の新しいサンプルを準備して試験する貴社の手順は科学的な正当性がない。また、XXのOOSの調査は、OOSの結果の根本原因を判断するための適切な指示が不足している。貴社の手順は、試験室の職員のXXを認めている。XXに科学的な正当性はない。
貴社は回答の中で、オリジナルの結果を確認するためにオリジナルのサンプルの再試験を実施する指示を含むOOSの調査に関する貴社の標準操作手順を改訂したと述べた。また貴社は、貴社のOOSの調査にはいつもXXが含まれていると述べた。しかし、貴社のOOSの調査レポートにXXは含まれていなかった。さらに、貴社は、XXを含むように、貴社のOOSの手順とOOSの調査レポートを改訂したと述べた。
貴社は全てのOOSの結果を完全に確定し、徹底的に調査したことを保証するためのXXの回顧的なレビュを提出しなかったので、貴社の回答は不十分である。貴社の改訂されたOOSの手順は、OOSの結果がいつ無効化できるかに関し、変更されていないままである。さらに、査察時点で、貴社の現在のOOSの手順もOOSの調査レポートも、オリジナルのサンプル標本XXのXXを評価していない。
不合格、規格外、傾向外またはその他の予期しない結果と貴社の調査の文書化のより詳細な情報については、FDAのガイダンス文書Investigating Out0of-Specification(OOS) Test Results for Pharmaceutical Productionを見よ。
この文書への回答の中で以下の情報を提供せよ：

  • 過去3年間に実施された製品試験について、全ての無効化されたOOS(リリース試験及び安定性試験を含む)の結果の回顧的で独立したレビュと、各OOSについて以下のことを含む、分析結果を要約したレポート：
    • 全ての無効化されたOOSの結果に関する科学的な正当化の理由と証拠が、決定的に、または、決定的ではない状態で、原因となる試験の誤りを示しているかどうか判断せよ。
    • 決定的に試験の根本原因を確証した調査に関し、論理的根拠を提出し、同じまたは類似の根本原因に対して脆弱な他の全ての試験方法が改善のために特定されていることを保証せよ。
    • 回顧的なレビュにより、試験で根本原因が非決定的または根本原因がないとわかった全てのOOSの結果に関し、顧客に送られた通知を含めよ。
  • 貴社のOOSの結果の調査システムの包括的なレビュと改善計画
    これに限定されないが、以下のことを、是正処置・予防処置（CAPA）に含めるべきである：
    • 試験室の調査の品質部門の監督
    • 有害な試験管理の傾向の特定
    • 試験のばらつきの原因の解決
    • 各調査とそのCAPAの適切な範囲の決定
    • これら及びその他の改善を含む改訂されたOOS

●指摘２

貴社は、試験方法の正確性、感度、特異性、再現性を確証し文書化することを怠った。
＜指摘２詳細＞
貴社はOTC医薬品を分析するために使用されている化学及び微生物の試験方法が意図した使用目的に適していることを保証するための方法の検証を実施することを怠った。例えば貴社は、さまざまな処方の異なる医薬品に含まれる有効成分XXについて、同じ分析試験方法を用いた。また、貴社は、各医薬品に対する方法の適合性の検証をせずに、抄録の試験方法を使って、微生物の存在に関し、さまざまな医薬品の試験をした。
貴社の回答は不十分である。貴社は、貴社の試験方法で生成されたデータが正確であるという保証を提出しなかった。試験方法の検証を終えるために貴社が提出したタイムフレームは適切ではない。
この文書への回答の中で、以下の情報を提供せよ：

  • 試験方法の適合性を判断するための化学及び微生物に関する医薬品の試験方法の包括的で独立した　アセスメント（すなわち、顧客のために実施する分析方法の検証またはバリデーション）
    もし検証またはバリデーションが必要な場合、適切な活動を完了するための計画とタイムラインと、結果を顧客に通知するという約束を提出せよ。
  • 全ての試験方法の適合性がどのように決定されるか、方法の検証とバリデーションがいつ行われるかを文書化した改訂された手順と、それに対応した教育記録

●指摘３

貴社は、権限を与えられた職員のみが製造指図記録書原本またはその他の記録の変更を行えることを保証するために、コンピュータ及び関連システムの適切な管理を行うことを怠った。
＜指摘３詳細＞
貴社が医薬品の製造結果の記録を生成するための電子データシステムは適切な管理が不足している。
貴社のシステムに、データの削除を防止し、データへの全ての変更を記録するための適切な管理が行われているという保証がない。例えば、医薬品の同一性試験に使用されている貴社のXXシステムで生成された電子データファイルは、削除されるおそれがある。さらに、貴社のOTC医薬品内の活性物質を試験するための高速液体クロマトグラフィーとガスクロマトグラフィーのシステムを管理するXXには、重要な変更を記録するための全ての適切な監査証跡がなかった。
貴社は回答の中で、装置とソフトウエアの製造業者に連絡し、データの削除を防ぐために必要な管理を実装するためのガイダンスを要求したと述べた。貴社は、何のデータが削除され、それによる貴社が試験した医薬品への影響を判断するためのデータシステムのアセスメントを提出しなかったので、貴社の回答は不十分である。さらに、貴社は貴社のソフトウエアシステムに更新を適用する間の、適切な暫定手段を講じることを怠った。
この文書への回答の中で、以下の情報を提供せよ：

  • 文書化手順のどこが不十分かを判断するための、貴社の試験室の試験作業に使用されている文書化システム(紙及び電子)の完全なアセスメント
    貴社が、貴社の作業を通じて、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修正する詳細なCAPAの計画を含めよ。
  • 適用可能な電子試験データシステムの監査証跡を有効にするためのアクションプランとタイムライン
    また、暫定的な管理について述べ、全ての監査証跡のレビュのために、いつ手順が実装されるかを明記せよ。

●契約試験機関の責任

FDAは、請負業者を製造業者自身の施設の拡張とみなす。貴社のCGMP遵守の不履行は、顧客のために貴社が試験した医薬品の品質、安全性、有効性に影響を与える可能性がある。
貴社がCGMPを完全に遵守して活動する責任を理解し、医薬品の試験中に見つかった全ての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は不可欠である。

●CGMPコンサルタントの推奨

我々が貴社で発見した違反の性質に基づき、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に規定された適格性のあるコンサルタントを雇うことを我々は強く勧める。
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違反の包括的なリストでもない。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。

出典：https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/accu-bio-chem-laboratories-619450-02242022

まとめ

いかがでしたでしょうか。

指摘の中には、実際の濃度がラベルの表示の100,000,000倍だったというような、びっくりする内容もありましたが、今回取り上げた2通の両方に、データ・インテグリティに関する指摘が含まれていたことが印象的でした。
耳にタコが出来そうなデータ・インテグリティですが、この機会に今一度、データ・インテグリティの基本要件であるALCOAが遵守できているかについて確認してみるのもよいのではないでしょうか。
＜ALCOA＞
A：Attributable　帰属性
L：Legible　判読性
C：Contemporaneous　同時性
O：Original　原本性
A：Accurate　正確性
※データ・インテグリティは、電子記録はもちろん、紙の記録にも求められているので、注意が必要です。

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