【最近のウォーニングレター】ASTROM通信 247号

新型コロナの感染状況が気がかりなところですが、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#622318■

22021年8月30日～9月14日のニューハンプシャー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12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、貴社が製造した医薬品が、それが持つとうたわれている、または、持つと表示されている同一性、濃度、品質、純度を持つことを保証するために設計された製造と工程管理に関する文書化された適切な手順を制定することを怠った。(21 CFR 211.100(a))

＜指摘１詳細＞

貴社は、さまざまなOTC医薬品を流通させているが、医薬品の製造工程を適切にバリデートすることを怠り、複数の製品に関する適切なプロセスバリデーションが不足していた。乳児向けを含む日焼け止めの製品の複数のロットにおいて、品質管理試験で規格外(OOS)の結果が出た。プロセスバリデーションがなければ、製品の品質に影響を与える製造の投入とパラメータの妥当性を理解し、規格を満たす製品を再現性よく提供する安定した操作ができるという基本的な保証が欠けている。
さらに、貴社には洗浄バリデーションが欠けていた。
適切なプロセスバリデーションが欠けていた期間中に、少なくとも23の固有な医薬品の品目コード
の少なくともXXロットを製造し、リリースし、販売した。これは繰り返しの違反である。

貴社は、貴社がコンサルタントとプロセスバリデーションを終えるために協力すると回答し、貴社の計画は部分的に完了したと述べた。貴社は、XXまでに検証を終えると計画した。また、貴社は、同じ日までに洗浄バリデーションを終えると計画したと述べた。

欠落または不十分なプロセスバリデーションに対応するための貴社の提案は、初期のバリデーション(工程の適格性評価(PPQ))が未だに不足している工程から製造された製品の販売を続ける計画をしているかどうかを明確に述べていないので、貴社の回答は不十分だった。同様に、貴社の洗浄バリデーションの提案は詳細が不足していた。貴社は前回の査察の対応と2019年11月19日にFDAと開催された規制会議で、工程バリデーション及び洗浄バリデーションの実施を約束していた。

しかし前回の査察以降、貴社は、貴社の製品のうち１つだけ(SPF30 ベビー日焼け止め)のPPQの検証を実施しただけで、その製品のバリデーション報告も完了していなかった。前回のプロセスバリデーションと洗浄バリデーションの約束の遵守を怠ったので、FD&C Actを遵守するという貴社の現在の約束を当局が信頼することは難しい。

プロセスバリデーションは、そのライフサイクルを通じで、工程の設計の妥当性と管理状態を評価するものである。製造工程のそれぞれの重要な段階は、適切に設計され、原材料・中間材料・最終製品の品質を保証しなければならない。工程の適格性評価の検証は、初期の管理状態が確立されているかどうかを判断する。商用の販売の前に、性能適格性評価の検証の達成が必要である。

その後、貴社が製品のライフサイクルを通じて安定した製造作業が維持されていることを保証するために、工程と製品品質の継続的で慎重な監視が必要である。

この文書への回答の中で、以下の情報を提供せよ：
・製品のライフサイクルを通じた、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サマリ（サマリには関連する手順を添えよ。）
　継続的な管理状態を保証するために、妥当な設計、工程の性能適格性評価、ロット内及びロット間のばらつきの継続的なライフサイクルのモニタリングに関するプログラムを説明せよ。
・貴社が販売している各医薬品に関する適切な工程の適格性評価(PPQ)の実施に関する最新の情報とタイムライン
　貴社が、プロセスバリデーションの検証がまだ終わっていない製品の更なる販売を計画しているかどうか説明せよ。また、工程性能のプロトコルと、装置や設備の文書化された適格性評価の手順を含めよ。
・貴社の医薬品製造作業におけるワーストケースとして特定された条件を取り入れることに特に重点を置いた洗浄バリデーションプログラムへの適切な改善
　改善には、これに限定されないが、以下の全てのワーストケースの特定と評価を含むべきである：
　〇より高い毒性を持つ医薬品
　〇より高い有効性を持つ医薬品
　〇洗浄溶液の中でより低い溶解度の医薬品
　〇洗浄を難しくする特性を持った医薬品
　〇洗浄を最も難しくする拭き取り場所
　〇洗浄前の最大保持時間
　さらに、新しい製造装置や新しい製品を導入する前に、貴社の変更管理システムでとられるべき手順を述べよ
・製品、工程、装置の洗浄手順の検証とバリデーションのための適切なプログラムが実施されていることを保証する最新の手順のサマリ
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的な原則とアプローチについて、FDAのガイダンス文書Process Validation : General Principles and Practicesを見よ。

●指摘２

貴社は、貴社の試験方法の精度、感度、特異度、再現性を制定し文書化することを怠った。
(21 CFR 211.165(e))

＜指摘２詳細＞

貴社は、サードパーティの契約試験機関(CTL)によって実施されたリリース試験に基づき、OTC医薬品を出荷した。その分析試験方法は、精度、特異度、再現性についてバリデートされていなかった。例えば、貴社のCTLが使用していた酸化亜鉛のリリ―ス試験方法は、別の顧客の亜鉛ベースの製品についてはバリデートされていたが、貴社の製品ではなかった。さらに、これらの検証されていない試験方法が貴社の特定の製剤の安定性を示すものであるという科学的エビデンスを欠いていた。FDAは、2年以上前の前回の査察中に試験方法バリデーションの欠如を貴社に伝えたが、その後も貴社は適切なリリース及び安定性の試験方法のバリデーションデータを持たずに、複数製品の多数のロットを製造し、リリースし、販売した。これは繰り返しの違反である。

貴社は、2021年8月10日のCTLの査察中、CTLが、亜鉛ベースのOTC医薬品の製剤に固有でない試験方法を使用していることに気付いたと回答した。また、貴社は、CTLと協力して、貴社の製品に必要な方法バリデーションを実施し始めたと述べた。

前の査察で、方法バリデーションの欠如が指摘されていたにも関わらず、是正処置・予防処置を開始するのになぜそれほど長い時間がかかったのかを説明しなかったので、貴社の回答は不十分である。貴社は2019年5月の査察中、酸化亜鉛のリリース試験と安定性試験の方法バリデーションがなかったが、2019年11月19日の規制会議で、方法バリデーションを完了すると約束した。貴社は前回の約束の遵守を怠ったので、現在の方法バリデーションの約束を当局が信頼することは難しい。

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、貴社の契約施設との契約に関わらず、医薬品の品質に責任がある。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。

この文書への回答の中で、以下の情報を提供せよ：

・再現性を確実にするために具体的な指示を含んでいることを保証するための、適切なバリデーション(またはアメリカ薬局方の簡便法による検証)で裏付けされ、使用目的にあった全ての試験方法の詳細な独立したアセスメント
　アセスメントは、安定性プログラムで使用されている試験方法が、安定性を示しているかどうかも判断すべきである。アセスメントの範囲は、貴社または契約試験機関で実施されている試験を網羅すべきである。
・全ての分析試験方法に関するバリデーション(または、適切な場合は、検証)の完了に関するステータスの報告とタイムライン
・貴社の全ての試験システムの包括的で独立したレビュと、試験作業の完全な修正を保証する是正処置・予防処置(CAPA)の計画
　例えば、貴社の試験システムのレビュは、これに限定されないが、全ての試験装置の適合性、修正されたキャリブレーションプログラム、職員の能力、監督監視、データシステム、その他の試験管理の要素を含むべきである。要件を遵守した試験システムに対するニーズは、貴社の代わりに試験を実施する試験機関にも及ぶ。
FDAが分析試験方法の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ついて、FDAのガイダンス文書：Analytical Procedures and Methods Validation for Drugs and Biologicsを見よ。

●指摘３

貴社は、ロットが既に出荷されているかどうかに関わらず、ロットやその成分の規格に対する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。 (21 CFR 211.192)

＜指摘３詳細＞

貴社の調査は不十分である。粘度と高い水分活性の結果で繰り返しOOSの結果を得たことが示すように、貴社は、効果のない是正処置と予防処置を行った。約2年の間に、貴社は粘度に関して少なくとも25回のOOSの結を記録した。同じ期間中に、貴社は少なくとも45回の高い水分活性のOOSの結果も記録した。水分活性が貴社の規格を超えていたら、貴社はバイオバーデンを試験しただろう。これらの高い水分活性のロットは、バイオバーデンでもOOSで、リリースができなかった。さらに、貴社は、2018年3月以降で、製品の粘度に関し少なくとも29件の苦情と、効能の不足に関し少なくとも129件の苦情を得ていた。これは繰り返しの違反である。

例えば、貴社は2020年6月9日に、SPF30 ベビー日焼け止めクリームの高い水分活性のOOSの事例を調査した。貴社は、XX内の水分が根本原因であると判断し、XX内の水分をより管理するためにXXを実施し、2020年8月17日に調査を終了した。しかし、XXの適用後も、高い水分活性に関する30件の追加のOOS（バイオバーデンで不合格になったいくつかのロットを含む）をみつけた。その後の30件の高い水分活性のうちの1件は、SPF35 キッズクリアフェイス日焼け止めスティックで発生した。高い水分活性結果の後に実施されたバイオバーデンの試験は、好気性微生物の総数が390cfu/mLで、規格から外れていた。貴社はこのロットを不合格にしたが、微生物の不具合の根本原因の特定をせず、他のロットが影響を受けているかどうかを判断するために調査を広げることもしなかった。成分として水を含まないと思われる製品内で、高い水分活性のOOSの結果や、バイオバーデンの不合格を得ているのも気がかりである。

不合格の粘度の結果に関する貴社の回答の中で、貴社は、粘度は重要な品質特性とみなさないと述べた。また貴社は、調査をより徹底的にするために、貴社の調査プログラムを修正すると述べた。

不具合を引き起こした要因について適切な調査を行わず、粘度の規格の重要性を軽視しているので、貴社の回答は不適切である。貴社は、潜在的な根本原因を解決するための適切なCAPAを決めず、他のロットがどのように損なわれていたかを充分に評価しなかった。粘度は、日焼け止めやクリームなどの外用医薬品にとって意味のある品質特性である。貴社の粘度の範囲は、ロットの処理過程で大きく変化し、製品の苦情の原因となった可能性がある。粘度は、医薬品の安定性や、医薬品の肌への塗布に重要で、例えば、アメリカ薬局方<911>粘度などのバリデートされた方法を使って測定される必要がある。

高い水分活性や、バイオバーデンの不合格の結果に関する貴社の回答において、貴社の調査の文書化が不十分であることを認めた。貴社は、継続する高い水分活性の結果を、XX内の高い水分という同じ原因のせいにし、CAPAのフォローアップは、XXからXXまでだった。貴社は、特定された問題が他のロットに影響を与えたかどうかのアセスメントを含めるために、調査手順をレビュするつもりであるとも述べた。多数のOOSや不合格の結果の、使用期限内でかつ市場にある貴社製品に対する影響の評価が不足しているため、貴社の回答は不十分である。FDAは2年以上前に、貴社の調査は、効果的なCAPAを可能にしていないと知らせていた。当時、貴社は、貴社の調査手順を改善するという同様の約束をした。しかし、貴社は、それ以降、調査手順の改善を怠っていた。査察時点で、貴社は、過剰な水分活性とバイオバーデンの不合格の結果に対応したCAPAのフォローアップを開始していなかった。当時貴社はXXの追加を検討しているとも述べた。

この文書への回答の中で、以下の情報を提供せよ：
・現在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製品に関し、全ての無効化されたOOS(工程内/リリース/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に関する以下の内容を含む分析で見つかった内容をまとめたレポート：
　〇無効化されたOOSの結果に関する科学的正当性及びエビデンスが、決定的または非決定的でないにしても、原因が試験エラーであると示しているかどうかを判断せよ。
　〇試験が根本原因であると最終的に確認され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。
　〇回顧的レビュで発見された、試験の根本原因が決定的でないか、根本原因が特定されていない全てのOOSの結果に関し、製造の徹底的なレビュ(例：ロットの製造記録、製造ステップの妥当性、装置/施設の適合性、原材料のばらつき、工程の能力、逸脱の履歴、苦情の履歴、ロットの不具合の履歴)を含めよ。各調査の潜在的な製造の根本原因と、製造作業の改善のサマリを提出せよ。
・貴社のOOSの結果の調査システムに関する包括的なレビュと改善計画

　CAPAは、これに限定されないが、以下のことへの対処を含むべきである：
　〇試験の調査の品質部門の監督
　〇有害な試験管理の傾向の特定
　〇試験のばらつきの原因の解決
　〇試験の原因が決定的に特定できない場合は製造の潜在的な原因の徹底的な調査の開始
　〇各調査とそのCAPAの適切な範囲の決定
　〇これら及びその他の改善を含むOOS調査手順の改善

●CGMPコンサルタントの推奨

貴社で確認した違反の性質に基づき、我々は、CGMPの要件を満たすように貴社を支援するために21 FR 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/ws-badger-company-inc-622318-04122022

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■CMS#622823■

2021年9月20日～9月24日のニュージャージー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、成分、医薬品の容器、蓋、中間材料、ラベル、製品が同一性、濃度、品質、純度の適切な規格に準拠していることを保証するために設計された科学的に妥当で適切な規格、標準、サンプリング計画、試験手順を含む試験管理を制定することを怠った。 (21 CFR 211.160(b))

＜指摘１詳細＞

貴社はアメリカ薬局方(USP)品のセタカインミントゲル局所麻酔薬を製造している。ベンゾカイン、ブタンベン、及び、塩酸テトラカインゲルの簡便法を使う代りに、エアロゾルの簡便法を使用した。貴社は、エアロゾルがこの製品のゲルの試験に適していることを適切にバリデートしていなかった。貴社は、2019年3月以降、完成したエアロゾル、液体、ゲル局所麻酔薬製品の有効性の試験に関しUSPから逸脱した。

さらに、貴社は、貴社の最終製品のリリース試験に使用しているXXに関する方法XXの方法バリデーションの検証を完了することを怠った。それゆえに、貴社は、貴社の方法が、現在のUSPの簡便方法と同等またはそれより優れていると十分に示していなかった。
貴社は回答の中で、今後、リリース試験にXX法を使用するつもりであると述べた。しかし、貴社は、貴社の方法がUSP法と同等またはそれより優れていると示すバリデーションを回答に含めていなかった。さらに、貴社の回答内で提供されたデータは、貴社のゲル製品に関する分析のためのカスタム試験方法(XX,XX)とUSP簡便法とで異なる結果を示した。貴社のラベルには、貴社の製品がUSPの規格を満たしていないことを明記していないため、ベンゾカイン、ブタンベン、テトラカイン塩酸塩ゲルのUSPモノグラフが、貴社のゲル医薬品の規制試験方法であることに注意せよ。
貴社が判断に使用する方法がUSPと同等またはそれより優れていると示すためのデータを提供していなかったので、貴社の回答は不十分である。さらに社は、規格を満たしておらずに合格と判定されてリリースされたロットの製品品質や患者の安全性のリスクに対処するための計画を提供しなかった。

この文書への回答の中で、以下の情報を提供せよ：
・代替方法がUSP法と同等またはそれより優れていると示されるまで、現在のUSP簡便法を使用するという約束
・現在のUSP簡便法を使用していない場合は、貴社の医薬品の試験方法がUSP法と同等またはそれより優れているかどうかを判断する包括的な検証
　貴社の代替方法がUSP簡便法と同等またはそれより優れているか評価する中で遭遇した全ての調査結果や逸脱を含めよ。分析試験方法のバリデーションに関するFDAの現在の考え方について、Analytical Procedures and Methods Validation for Drugs and Biologicsを見よ。
・貴社の医薬品が、同一性、濃度、品質、純度に関する適切な規格に従っていることを保証するために、　市場に出荷され使用期限内の全ての医薬品の全ての保管サンプルのバリデートされた試験方法(例：USP法)を使った最新の試験結果
・アメリカ市場にある貴社の医薬品の製品品質や患者の安全性のリスクに対応するための、顧客への通知、改修、市場からの撤退の可能性を含む貴社のアクションプラン

●指摘２

貴社は、ロットが既に出荷されているかどうかに関わらず、ロットやその成分の規格に対する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。 (21 CFR 211.192)

＜指摘２詳細＞

貴社はバリデートされていない方法を使って貴社のゲル製品を分析した際、規格外(OOS)の試験結果の適切な調査を怠った。貴社の分析は、有効性(XX)114.7%と115.2%で、テトラカインHCLのOOSを明らかにした。貴社は調査中、ベンゾカイン、ブタンベン、テトラカイン塩酸塩ゲルのUSP簡便法を使って再試験をし、また、118.9%と118.3%（XX）のOOSの結果を得た。簡便試験方法で不合格になった医薬品は、501(b)条のもとで不良品とみなされる。

適切な科学的正当性がなく、2つの追加の方法XXとXXを使ってサンプルを再試験し、合格の結果を得た。それから貴社は、簡便試験方法を使ったOOSの試験結果を含むOOSの試験結果を無効化するための十分な理由もなく製品をリリースした。

貴社は回答の中で、OOSの調査は、品質部門のロットをリリースするという判断を裏付ける徹底的な調査だったと信じていると述べた。貴社は、簡便法を使った際のOOSを含む、繰り返しの試験に関する科学的に妥当な正当化の理由を立証せず、合格結果を得るまでサンプルを繰り返し試験しているので、貴社の回答は不適切である。再試験に関して十分に確証された手順やプロトコルはOOSの調査の一部であるが、手順は科学的に妥当な原則に基づき、適切にバリデートされ検証された方法でなければならない。

この文書への回答の中で、以下の情報を提供せよ：
・アメリカ向け製品で、現在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、全ての無効化されたOOS(工程内/リリース/安定性試験を含む)の結果の回顧的な独立したレビュと、各OOSに関する以下のことを含む、分析結果をまとめたレポート：
　〇無効化されたOOSの結果に関する科学的正当性及びエビデンスが、決定的または非決定的でないにしても、原因が試験エラーであると示しているかどうかを判断せよ。
　〇試験が根本原因であると最終的に確認され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。
・回顧的レビュで発見された、試験の根本原因が決定的でないか、根本原因が特定されていない全てのOOSの結果に関し、製造の徹底的なレビュ(例：ロットの製造記録、製造ステップの妥当性、装置/施設の適合性、原材料のばらつき、工程の能力、逸脱の履歴、苦情の履歴、ロットの不具合の履歴)を含めよ。各調査の潜在的な製造の根本原因と、製造作業の改善のサマリを提出せよ。
・貴社のOOSの結果の調査システムに関する包括的なレビュと改善計画
　CAPAは、これに限定されないが、以下のことへの対処を含むべきである：
　〇試験の調査の品質部門の監督
　〇有害な試験管理の傾向の特定
　〇試験のばらつきの原因の解決
　〇試験の原因が決定的に特定できない場合は製造の潜在的な原因の徹底的な調査の開始
　〇各調査とそのCAPAの適切な範囲の決定
　〇これら及びその他の改善を含むOOS調査手順の改善

●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/cetylite-industries-inc-622823-04142022

まとめ

いかがでしたでしょうか。

今回のウォーニングレターは2件とも、OOSの結果への対応不備の指摘が含まれていました。今回のウォーニングレターにあった下記の指摘は、頻繁にウォーニングレターに登場します。
・OOSの結果が出ても、その結果を無効化し、合格が出るまで再試験を繰り返す
・OOSの原因を十分に調査していない
・OOSの影響範囲（他のロットや他の製品）を評価していない
・CAPAにつなげていない
奇しくも、日本のPMDAの7月のオレンジレターにもOOSに関する指摘がありましたので、是非、チェックをしてみていただければと思います。

https://www.pmda.go.jp/files/000247221.pdf

弊社サービスのプロス

https://drmarketing.jp/cch/73/640/3/377/501330/ee3281

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【発行責任者】

株式会社プロス　『ASTROM通信』担当　橋本奈央子 hashimoto@e-pros.co.jp

※本記事は株式会社プロスの許可を得て転載しております。

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