ゴールデンウィークが近づいてきましたが、いかがお過ごしでしょうか？
今回も、アメリカ食品医薬品局（FDA)が国内外の製薬会社に出したウォーニングレター２件を取り上げ、FDAがどのような点を問題視して指摘したかを確認していきたいと思います。
是非最後まで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。
■CMS 644745■
2022年8月30日～9月9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2023年3月1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。
CGMP違反
●指摘１
貴社は医薬品の各成分の同一性を確認するために少なくとも1つの試験を実施することを怠った。
(21 CFR 211.84(d)(1))
＜指摘１詳細＞
貴社は、医薬品の製造に使用する前に、有効成分(API)を試験することを怠った。具体的には、医薬品の少なくともXXのロットは、同一性試験が実施される前に製造され、その後リリースされた。
成分の試験は医薬品の品質の基本である。適切な試験がなければ、貴社は、医薬品の製造に使用する前に、入荷した成分が適切な規格に従うという科学的なエビデンスを持っていない。
貴社は回答の中で、現在全ての品質マネジメントシステムの手順とプロセスを開発・レビュ・更新し、全ての職員の役割と責任の評価をしていると述べた。また貴社は、成分のテストと受入に関する手順が強化される予定であるとも述べた。
貴社の回答は不十分である。成分の受入と試験の手順の改訂は、手順の実装に関するタイムラインや、実施される特定の試験等に関する詳細が不足している。貴社の回答は、同一性試験の実施前の成分の使用や、これらの成分を含む医薬品をリリースすること、供給者の適格性評価に対処されていなかった。この手順の影響の評価や調査は提出されず、他の成分が不適切に利用された場合の評価もなかった。
この文書への回答の中で、以下の情報を提供せよ：
- 成分、容器、蓋の全ての供給者が適格性を評価され、原材料に適切な使用期限やリテスト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なレビュ
レビュは入荷した原材料の管理が、不適切な成分、容器、蓋の不適切な使用を防ぐために適切かどうかも判断すべきである。 - 同一性、濃度、品質、純度に関する全ての適切な規格への一致について、貴社が各成分のロットをいかに試験するかについての記述
もし貴社が、各成分のロットの濃度、品質、純度に関する試験をする代わりに、供給者の分析証明書(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して、供給者の試験結果の信頼性をいかに厳格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。
●指摘２
貴社は、貴社が製造する医薬品が、それが持つとうたわれている、または、表示されている同一性、濃度、品質、純度を持つことを保証するために設計し文書化された手順と工程の制御を制定することを怠った。(21 CFR 211.100(a))
＜指摘２詳細＞
貴社には、安定した製造作業と一貫した医薬品の品質を保証するために、工程の制御をモニタリングするための適切な継続的プログラムが欠けていた。具体的には、貴社は、貴社のOTCの日焼け止め医薬品の製造工程がバリデートされていることを示す文書を提供しなかった。
FDAがプロスバリデーションの要素と考える一般的な原則とアプローチに関し、FDAガイダンス文書Process Validation : General Principles and Practicesを見よ。
さらに貴社は、医薬品を製造するために使用されている水が、XX水に関するアメリカ薬局方(USP)モノグラフを満たし、医薬品用に適していることを示すデータを提出出来なかった。具体的には導電率と全有機炭素(TOC)試験が実施されていなかった。
貴社は回答の中で、マスタバリデーションプランを提供した。さらに、貴社はXXを約束した。
貴社の回答は、完了までのタイムラインを含む、計画されたバリデーション活動に関する十分な情報が欠けているので、不十分である。また貴社の回答はTOCと導電率試験について述べていない。
この文書への回答の中で、以下の情報を提供せよ：
- 関連する手順と共に、貴社の各製造工程に関する、製品のライフサイクルを通じて管理状態を保証するためのバリデーションプログラムの詳細な概要
継続的な管理状態を保証するための、工程性能の適格性評価と、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を述べよ。 - 販売されている貴社の各医薬品に関する工程性能の適格性評価(PPQ)に関するタイムライン
- 装置及び設備の適格性評価のための、工程性能プロトコル及び文書化された手順を含めよ。
- 貴社の水システムの設計、管理、メンテナンスの包括的なアセスメント
- 適切な水システムを設置し運用するための徹底的な改善計画
XXシステムが、USPモノグラムの規格と適切な微生物の限界値に関するXX水の規定を遵守した 水を一貫して精製することを保証するための、安定した継続的な管理、メンテナンス、モニタ リングプログラムを含めよ。 - 後者に関しては、貴社の水の総菌数の限界値が貴社で製造される医薬品の使用目的の観点で適切であることを保証せよ。
- 発見された水システムの不具合の、現在アメリカ国内で販売されているかまたは使用期限内にある全ての医薬品のロットの品質への影響の可能性を考慮した詳細なリスクアセスメント
リスクアセスメントに応じて貴社が実施しようとしている顧客への通知や製品の回収などのアクションを明記せよ。
●指摘３
貴社は、適切な品質部門を制定することを怠り、品質管理部門に適用する責任と手順は文書化されておらず、遵守されていなかった。(21 CFR 211.22(a),(d))
＜指摘３詳細＞
具体的に、貴社の品質部門(QU)は、これに限定されないが以下のことを含む重要な監督責任を述べた手順を制定することを怠った：
調査、変更管理、顧客の苦情、教育、是正処置・予防処置(CAPA)、逸脱、年次製品照査、品質部門の作業に関する文書化された手順
さらに、貴社は、貴社の医薬品の化学及び微生物学的特性が制定された規格を満たし、付与された有効期間を通じて許容可能な状態にあることを示すための適切な安定性データを持っていなかった。例えば、貴社は貴社の医薬品の各製剤の適切な数のロットを安定性試験の対象にしなかった。さらに、製剤XX、XXの安定性サンプルにおいて、規格外（OOS）の粘度の結果が得られた。貴社は、粘度のOOSの結果の適切な調査を実施しなかった。
貴社は回答の中で、全ての品質マネジメントシステムの手順とプロセスを、現在、開発、レビュ、改訂中であると述べている。貴社は、手順が実装されるので、適用される職員全てに教育を実施し、後の最新の回答に、文書化したエビデンスを含めるつもりでいる。粘度が貴社製品にどのような影響を与えるかの情報と、粘度が安定性試験中に変わる可能性があるという情報を提供せよ。貴社は、粘度の規格の評価を続け、不具合に関するOOSの調査を開始すると約束した。
貴社の回答は不十分である。貴社は手順の改訂の目標完了日を提出していない。さらに、教育手順がない状態で職員に訓練することは適切でない。
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に権限とリソースを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
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むべきである：- 貴社で使用されている手順が安定していて適切かどうかの判断
- 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の監督に関する規定
- QUのロットの処遇の決定前の、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 の実施
- 調査の監督と承認と、全ての製品の同一性、濃度、品質、純度を保証するためのQUのその他全ての職務の遂行
- 貴社の安定性プログラムの適格性を保証するための包括的なアセスメントとCAPAの計画
修正するプログラムには、これに限定されないが以下のことを含むべきである：- 安定性を示す方法
- 出荷許可前に、販売される容器施栓システムの中の各医薬品の安定性の確認
- うたわれている使用期限が妥当かどうかを判断するための、製品XXのXXの代表的なロット がプログラムに追加されるような継続的プログラム
- 各工程（タイムポイント）で試験される特定の属性の詳細な定義
- 貴社の改善された安定性プログラムのこれら及びその他の要素を述べた全ての手順
●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は請負業者を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任がある。貴社には、医薬品が安全性、同一性、濃度、品質、純度に関し、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。
●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はない。貴社には、全ての違反を調査し、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。この問題に迅速かつ適切に対応しない場合、通知なしで、これらに限定されないが、差し押さえや差し止め命令を含む規制または法的措置につながる可能性がある。未解決の違反は、他の連邦政府当局との契約を阻むかもしれない。
違反への対応の不履行は、FDAの輸出証明書の発行の差し控えにつながる可能性がある。全ての違反が完全に対応され、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。また、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。
～～～～～～～～～～～～～～～～～～～～～～～～～～～～～～～～～～～～～～～～
■CMS 642267■
2022年7月26日～8月1日のプエルトリコの貴社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2023年2月15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。
◆不衛生な状態
貴社の医薬品は、不衛生な状態で準備、包装、保持されていたので、FD&C Act 501(a)(2)(A)のもとで、粗悪品である。査察中、我々査察官は、貴社の施設で虫や不潔な状態を見た。施設内のコンテナの閉合部分 (ボトルとキャップ) の内側で虫が見つかった事例が数件あった。我々は、手指の消毒剤で見つかった虫についての消費者の苦情にも気付いている。
更に、貴社の施設は、医薬品製造と、工業用化学薬品の製造の適切な分離や、外部環境からの適切な保護が不足していた。例えば、同じエリア(例：倉庫、製造)や装置が、貴社の医薬品や工業用化学薬品の製造に使用され、施設のドアは製造中外部環境に開放されていた。
◆GMP違反
●指摘１
貴社は、汚染や取り違えを防ぐために必要な、隔てられているか、または、分かれたエリアや、その他の制御システムを持つことを怠った。(21 CFR 211.42(c))
＜指摘１詳細＞
貴社は、消毒用アルコールや手指の消毒剤などのOTC医薬品を製造している。また貴社は市販の工業用化学薬品(苛性及び酸性ベースの洗浄剤及び消毒剤を含む)も、OTC医薬品と同じ製造装置上で製造している。
例えば、混合タンクと充填ラインXXは、OTC医薬品の製造の前後に、皮膚刺激物(XXに使用されるXX等)を含む非医薬品の工業用化学薬品を製造するために使用された。
CGMPとして、交叉汚染のリスクや取り違えの可能性により、工業用化学薬品を製造するために使用しているのと同じ装置を使って医薬品の製造を続けることは受け入れられない。
●指摘２
貴社は、公式またはその他の制定された要件を超えて医薬品の安全性、同一性、濃度、品質、純度を変える誤作動や汚染を防ぐために、適切な間隔で装置や器具を洗浄、メンテナンス、医薬品の性質に応じて消毒/滅菌をすることを怠った。(21 CFR 211.67(a))
＜指摘２詳細＞
貴社の施設内の装置は破損した状態でみつかった。例えば、我々査察官は、充填装置の表面にさびのような残留物と、製品に触れる充填ラインのインジェクタノズルに汚れて傷んだシールの存在を見つけた。さらに、医薬品と非医薬品の工業用化学薬品を製造するために使用される充填ラインXXに関して、文書化された洗浄手順や、装置の使用ログを保持していなかった。
適切に設計されメンテナンスされている装置のみが、貴社の医薬品の製造で使用されることを保証するのは貴社の責任である。
●指摘３
貴社が製造する医薬品が、それが持つとうたっている、または、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した製造と工程制御に関する文書化された手順を制定することとを怠り、また、製造及び工程制御の文書化された全ての手順に従うことを怠った。(21 CFR 211.100(a)、21 CFR 211.100(b))
＜指摘３詳細＞
貴社は、貴社の水システムが、貴社の医薬品の製剤に使用される水の製造に適していることを確実にするために適切に設計し、バリデートし、制御することを怠った。例えば、貴社には、水システムのバリデーション、成分水の化学及び微生物の限界、化学及び微生物の品質の定期的なモニタリングが欠けていた。
貴社の水システムの不十分な管理とモニタリングは、医薬品の好ましくない汚染が存在する潜在的なリスクをもたらす。
医薬品用の水は、精製水のUSPモノグラフを満たし、使用目的に合っていて、適切な化学及び微生物学の属性への継続的な一致を保証するために定期的に試験されていなければならない。
●指摘４
貴社は、同一性と、純度、濃度、品質の文書化された全ての規格への一致について、各成分のサンプルを試験することを怠った。また貴社は、適切な間隔で、貴社の成分の供給者の分析試験の信頼性をバリデートして確認することを怠った。(21 CFR 211.84(d)(1)、21 CFR 211.84(d)(2))
＜指摘４詳細＞
〇成分試験
貴社は、有効成分(すなわちイソプロピルアルコール)を含む、貴社の医薬品の製造に使用される成分の各ロットについて同一性を試験することを怠った。さらに、貴社は、貴社の供給者から得た分析証明書(COA)を信頼し、成分の規格や特性について、各供給者のCOAの信頼性を確認することを怠った。
〇エタノールを含む製品(メタノールリスク)
貴社はエタノールを含む複数の医薬品を製造している。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命的中毒事件をもたらしてきた。
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。
〇グリセリンを含む製品
貴社はグリセリンを含む医薬品を製造している。ジエチレングリコール(DEG)に汚染されたグリセリンの使用は、世界中の人々の様々な致命的中毒実験をもたらしてきた。
貴社がグリセリンを含む医薬品を製造する際にCGMP要件を満たす助けとして、FDAのガイダンス文書Testing of Glycerin for Diethylene Glycolを見よ。
貴社は使用前に各成分が同一性、純度、濃度、品質に関する全ての適切な文書化された各規格に一致するかを判断することを怠った。
●指摘５
貴社の品質管理部門は、製造された医薬品は、同一性と、純度、濃度、品質の文書化された全ての規格への一致について、各成分のサンプルを試験することを怠った。(21 CFR 211.22)
＜指摘５詳細＞
〇品質システム
貴社は貴社の医薬品の製造を監督するための責任と権限を持った適切な品質部門(QU)を制定することを怠った。例えば、貴社は下記のことを保証するのを怠った：
- ベンダの適格性評価、ロットのリリース、保管サンプル、苦情、変更管理、プロセスバリデー ション、装置の洗浄、CGMPの教育の対応を含む、QUの役割と責任を述べた適切な手順
(21 CFR 211.22(a)＆(d)) - 安定性プログラムの遵守(21 CFR 211.166(a))
- 年次製品照査の実行(21 CFR 211.180(e))
- 一貫性があり完了したバッチレコード(21 CFR 211.188)
- 逸脱の適切な調査(21 CFR 211.192)
貴社の品質システムは不十分である。CGMPの規制要件21 CFR 210,211を満たすために品質システムとリスクマネジメントアプローチを実装する助けとして、FDAのガイダンス文書
Quality Systems Approach to Pharmaceutical CGMP Regulationsを見よ。
〇最終製品試験
貴社は、適切な最終製品試験を実施せずOTC医薬品をリリースし出荷した。例えば、貴社は、製造記録の一部として、限られたリリース試験(温度、臭気、外観、アルコール濃度)のみ実施した。しかし、21 CFR 211.165(a)で要求されている通り、医薬品のリリースと出荷の前に、同一性、濃度、品質、純度を含む完全なリリース試験が実施されなければならない。
また貴社は21 CFR 211.165(b)で求められている、好ましくない微生物が存在しないことを保証するための試験など、重要な微生物属性の試験をせずに最終医薬品をリリースした。
医薬品は、リリースと出荷の前に、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。適切な試験を実施しなければ、貴社の医薬品がリリース前に適切な規格に従っていることを保証するための科学的なエビデンスがない。
〇医薬品の製造停止
2022年12月12日、FDAは貴社と電話会議を実施した。我々は現在販売されている医薬品のロットのアメリカ市場からの排除と更なる出荷の停止を検討することを勧めた。
2022年12月13日、貴社は、今後医薬品を製造する意図はなく、全ての医薬品の製造と出荷を停止するという約束を伝え、2021年12月31日以降に製造された全ての医薬品を自主回収することに同意した。2022年12月21日、FDAはウエブサイトで一般に対し、医薬品が危険な工業用医薬品の交叉汚染の可能性があり、不衛生な状態のもとで製造されたと通知した。
我々は、貴社がこの施設で医薬品の製造を停止すると約束したと認識している。
この文書への回答の中で、貴社がこの施設または他の施設で医薬品の製造を再開するつもりかどうかを回答せよ。もしFD&C Actのもとで規制されている製造を再開するつもりなら、医薬品の製造作業を再開する前に連絡せよ。もし貴社がCGMP活動を再開するつもりなら、貴社には、貴社が継続的にCGMPを遵守できることを保証するために、全ての不具合とシステムの欠陥を解決する責任がある。さらに、我々が貴社で確認した違反の性質に基づき、貴社は、CGMPの要件を満たす助けをする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べきである。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6つのシステムの包括的な監査を実施し、CAPAの完了と効果を評価すべきである。
●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はない。貴社には、全ての違反を調査し、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。この問題に迅速かつ適切に対応しない場合、通知なしで、これらに限定されないが、差し押さえや差し止め命令を含む規制または法的措置につながる可能性がある。未解決の違反は、他の連邦政府当局との契約を阻むかもしれない。
違反への対応の不履行は、FDAの輸出証明書の発行の差し控えにつながる可能性がある。全ての違反に完全に対応され、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。また、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。
指摘内容から、指摘されたどちらの会社も、品質管理を十分に行っていない状態がうかがえます。
ウォーニングレターで指摘されている手指の消毒薬のずさんな製造の状況を見ると、品薄時に必死で購入した消毒薬の品質に問題はなかったのだろうかと不安になると同時に、パンデミック下での製造管理は大きな課題であるとあらためて感じました。
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