【最近のウォーニングレター】ASTROM通信 239号

今年も桜の季節になりましたが、いかがお過ごしでいらっしゃいますか。

さて今回は、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件を取り上げ、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。
アメリカ国内向けの指摘ではありますが、GMP査察のチェックポイントという点で参考にして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#616877■

2021年6月23日～7月1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2021年12月29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、返品された医薬品が再出荷の前に、安全性、同一性、濃度、品質、純度の適切な基準を満たすことを保証するのを怠った。
＜指摘１詳細＞
貴社の、返品された医薬品の再出荷前の取り扱いは不適切である。例えば査察中、貴社は、返品された医薬品が返品前及び再出荷前における、保持、保管または出荷された状態のラベルを確認する検査・調査の文書を提出できなかった。さらに貴社は返品された製品の安全性・同一性・濃度・品質・純度を保証するための適切な試験を実施することを怠った。製品が不適切な保管状態にさらされていたかもしれない後で、官能検査だけでは、その安全性・同一性・濃度・純度・品質を保持していることを保証するのには不十分である。
再出荷前に貴社は返品された複数のロットのカプセルを新しいロット番号を持つ新しいロットに結合した。これらの新しいロットは、3年以内に使用期限切れになるカプセルを含み、均一の特性と品質を持っていなかった。しかし貴社は、これらの結合されたロットに新しいロット番号を割り当て、さらに3年間の使用期間を与えた。新しい使用期限は、安定性のデータにより裏付けされていないし、ある場合は、返品された製品の18ヶ月の使用期限を超えていた。貴社のバッチレコードは、再出荷前にこれらの結合されたロットに対して貴社が実施した試験を示していなかった。
返品前の状態が不明の製品に官能試験を実施し、返品されたさまざまなロット番号と使用期限を持った製品を結合してロットを作成し、返品された製品の使用期限に関わらず新しい使用期限を与える貴社の業務は受け入れられない。
この文書への回答の中で以下の情報を提供せよ：

  • 返品された医薬品の再出荷のための取扱いや処理の適切性を保証するための包括的で独立したアセスメントと改善計画
    これに限定されないが、以下のことに含む、詳細なアクションプランとそれに関連する手順を提出せよ：
    • 返品された製品が返品前・返品中・返品後に保持・保管・出荷された状態、返品の理由、返品数、処分の日、医薬品の品質に関して疑いがある場合を含む最終的な処分の手順
    • 返品された製品の、保持・保管・出荷の状態が医薬品の安全性、同一性、濃度、品質、純度に悪い影響を与えなかったことを保証するための手順
  • アメリカに再出荷されたロットに関連する、顧客への通知や回収の可能性も含む、品質リスクに対応するためのアクションプランを提出せよ。

●指摘２

貴社は、貴社が製造した医薬品が、それが持つ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や工程管理に関する文書化された手順を制定するのを怠り、貴社の品質管理部門は変更を含むこれらの手順をレビュし承認しなかった。
＜指摘２詳細＞
貴社は、貴社のOTC医薬品XXを製造するのに使用される工程を適切にバリデートしていなかった。
貴社は2017年12月に、複数の成分の廃止を含む、XXの製法の変更を行った。貴社はプロセスバリデーションのプロトコルと、関連する分析試験レポートを、それぞれ、1年後の2018年11月及び12月まで発行しなかった。さらに、2018年11月のバリデーションプロトコルの裏付けをする2014年10月21日付の唯一のデータは、以前の製法の試験で、現在の製法を反映していない。
2017年12月の製法変更以来、貴社はアメリカ向けに、少なくともXXロットの不十分なプロセスバリデーションデータを持った医薬品を製造し出荷した。
貴社は回答の中で、プロセスバリデーションのための新しい標準操作手順(SOP)を作り、プロセスバリデーションの検証結果を文書化しレビュするつもりであると述べた。さらに、貴社は2021年8月の最初のプロセスバリデーションの製造を開始するつもりであると述べた。
プロセスバリデーションの検証実施の不履行は、製品の品質特性の不具合につながる可能性があるので、貴社の回答は不適切である。貴社は、貴社の製造工程が再現可能で均一な性質と品質を持つ製品を生産するために管理されていることを適切に示していないならば、医薬品の製造を続ける正当な理由を示すことにも対処していない。
この文書への回答の中で以下の情報を提供せよ：

  • 製品のライフサイクルを通して、関連する手順も含めた管理状態を保証するための貴社のバリデーションプログラムの詳細なサマリ
    貴社の工程性能適格性評価に関するプログラム、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ついて述べよ。
  • 貴社が販売している製品の、適切な工程性能適格性評価の実施に関するタイムライン
  • 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慎重な監視を含む、貴社の製造工程の設計、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を提出せよ。
    また、貴社の装置及び設備の適格性評価に関するプログラムも含めよ。
  • 製造工程等のばらつきの全ての原因を特定し管理する、データ駆動型で科学的に合理的なプログラムがあり、適切な規格と製品の標準を一貫して満たすことを保証するための、各医薬品の工程のアセスメント
    アセスメントは、これに限定されないが、装置の使用目的への適合性、貴社のモニタリング及び試験システムの検知能力の十分性、投入原材料の品質、製造工程の手順と管理の信頼性の評価を含めよ。
  • 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、変更が理にかなっていて、レビュされ、品質部門(QU)に承認されていることを保証するための貴社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、変更の有効性を判断するための規定も含めるべきである。

プロセスバリデーションは、そのライフサイクルを通して工程の設計と管理状態の妥当性を評価するものである。製造工程の重要な各段階は、適切に設計され、投入する原材料、工程原料、最終製品の品質を保証していなければならない。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ものである。
上首尾の性能適格性評価は、商用の出荷前に必要である。その後、製品のライフサイクルと通じて、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、工程性能と製品品質の継続的で慎重な監視が必要である。
FDAがプロセスバリデーションの適切な要素とみなす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３

貴社は、試験方法の正確性、感度、特異性、再現性を立証し文書化することを怠った。
＜指摘３詳細＞
貴社は、製品XXのリリースの規格に使用されている分析方法を適切にバリデートしていなかった。
具体的には、貴社の最終製品の規格で示されている通り、規格毎に、XXの波長で、分析光度計を用いた方法XXが実施されていることになっているが、バリデーションレポート内のデータによれば、貴社はXXの波長を使用していた。さらに、分析方法のバリデーションレポートは、システムの適合性も、変更した方法が目的に合っていることも示していなかった。
貴社は回答の中で、分析方法のバリデーションは、正しい波長で実施されたと述べた。貴社の回答は以下の点で不適切である。

  • 分析方法のバリデーションが正しい波長で実施されたという貴社の主張を裏付ける文書に欠けていた。
  • 適切にバリデートされていないし、現在市場にある医薬品の販売継続の正当な理由も示していない分析方法を使ってリリースされた製品のリスクアセスメントを提出しなかった。

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を改善し効果を評価する詳細な計画を提出せよ。
  • 全ての試験方法が適切にバリデートされ、意図した使用目的に合っていることを保証するための包括的で独立したアセスメント
  • 医薬品が製品の規格に従っていることを保証するために、現在市場にある全ての医薬品の保管サンプルの、バリデートされた試験方法を使った回顧的なアセスメント
  • データを記録するために使用された、管理されていない文書(例：法定の紙)から得たデータの完全性、一貫性、正確性のレビュ
  • 貴社の製品に適用可能な簡便法のレビュ

バリデーション方法に関する一般原則とアプローチに関し、
FDAのガイダンス文書Q2(R1) Validation of Analytical Procedure and Analytical Procedures and Methods Validation for Drugs and Biologics
を参照せよ。

●指摘４

貴社は、医薬品の安定性を評価し、保管条件と使用期限を決定するために安定性試験の結果を使用するよう設計された文書化された試験プログラムに従うことを怠った。
＜指摘４詳細＞
貴社の安定性プログラム不適切である。具体的には、貴社は、製品XXのXXだけ安定性試験を実施し、少なくとも2017年9月以降、安定性試験の実施を怠った。さらに貴社は新しい製法を使って製造された製品に関する安定性データを持っていなかった。従って、この医薬品のXXの使用期限を実証するための安定性データが不足している。
貴社は回答の中で、安定性の検証の実施が遅れているのは、QUのリソースが限られているためであると述べた。貴社は、医薬品の使用期限を決定するために、長期の継続的な安定性試験XXと、加速安定性試験を開始するつもりであると述べた。
貴社は、2013年の査察以来、貴社の安定性プログラムが不十分であることに気付いているので、貴社の回答は不十分である。その後の2015年、2018年、2021年の査察で、貴社の安定性プログラムにおいて、同一または類似の査察結果があった。貴社の回答は、貴社が安定性プログラムを改善するために、2013年から現在の査察の間で貴社が実施したことに関する情報が欠けていた。
この文書への回答の中で、以下の情報を提供せよ：

  • 貴社の安定性プログラムの妥当性を保証するための、包括的なアセスメントと是正処置・予防処置(CAPA)の計画
    貴社のCAPAの計画には、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
    • 出荷が許可される前の、販売されている容器密閉システムにおける各医薬品の安定性の研究
    • 使用期間が妥当であるかどうかを判断するために、毎年各製品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なプログラム
    • 各段階（タイムポイント）で試験される特性の詳細な定義
  • 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説明する全ての手順

安定性試験の一般原則とアプローチに関し、
FDAのガイダンス文書Q1A(R2) Stability Testing of New Drug Substances and Products
を参照せよ。

●指摘５

貴社の品質管理部門は、全ての手順や、医薬品の同一性・濃度・品質・純度に影響を与える規格の承認や拒絶をすることを怠った。
＜指摘５詳細＞
貴社は、貴社の製品の安全性・同一性・濃度・品質・純度に影響を与えるかもしれない全ての手順を制定しレビュし承認することを怠った。具体的に、貴社のQUは医薬品を製造するために使用される装置を操作するためのSOPなど、医薬品の品質を保証するために重要なSOPを実装することを怠った。
貴社は回答の中で、該当するSOPを作成・改訂するつもりであると述べた。貴社は、裏付け文書（例：SOPのドラフト、教育）を提出することを怠ったので、貴社の回答は不十分である。さらに、2012年、2013年、2018年の査察における繰り返しまたは類似の査察結果に対して同様の回答をした。従って、貴社の是正処置が実装されるという保証がない。
この文書への回答の中で、以下の情報を提供せよ：

  • 品質部門が効果的に機能するための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もふくむべきである：
    • 貴社で使用されている手順が安定していて適切であるかどうかの判断
    • 適切な手順の順守を評価するための、QUによる、貴社の作業全体の監督の規定
    • QUの出荷判定前の、ロット及び関連する情報の完全で最終的なレビュ
    • 調査の監督と承認及び全ての製品の同一性、濃度、品質、純度を保証するためのQUのその他の職務からの解放
  • 文書化手順の不十分な場所を判断するための、貴社の製造及び試験の作業を通じて使用され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。
  • アメリカに販売された貴社の医薬品に関する、製品の品質や患者の安全性のリスクに対応するための、顧客への通知や回収の可能性も含むアクションプラン

一般原則とアプローチに関し、
FDAのガイダンス文書：Quality Systems Approach to Pharmaceutical CGMP Regulationsを参照せよ。

●品質部門の権限

貴社の査察の履歴とこの文書内の重要な調査結果は、貴社のQUがその権限・責任を完全に果たしていないことを示している。貴社は、その責任を果たし医薬品の品質を一貫して保証するために、QUに適切な権限と十分なリソースを提供しなければならない。

●設備での繰り返しの査察結果

2018年に実施された先の査察で、FDAは同様のCGMPの査察結果を挙げた。貴社は、回答の中で、これらの査察結果に対する具体的な改善を提案した。繰り返される不具合は、経営陣の医薬品製造の監督と管理が不十分であることを示している。

●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、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。
我々は、適格性のあるコンサルタントが、CGMP遵守に関し貴社の全ての作業を包括的に監査し、貴社のコンプライアンス状態の解決をFDAと追求する前に、貴社のCAPAの完了と効果を評価することも勧める。
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/health-plus-inc-616877-12292021

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■CMS#617201■

2021年5月5日～5月7日、5月10日、5月13日～5月14日、5月18日、5月21日、5月24日～5月28日、6月3日、6月9日～6月10日、6月23日のニューヨーク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1月7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

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。
＜指摘詳細＞
貴社の規格外(OOS)の試験結果の調査は不十分であった。貴社は、OOSの結果をタイムリーな方法で調査し、適切に根本原因を特定し、影響を受けた可能性のあるロットに調査を拡大し、是正処置・予防処置(CAPA)を実施し、CAPAの効果を評価することを怠った。

A.2020年2月6日、医薬品XXロット12000124のクロルヘキシジングルコン酸塩(CHG)の分析試験結果について、調査OOS20-0032-NYが開始された。
報告されたCHGの割合は1.57％だった。
貴社の品質部門(QU)は、分析者がサンプルの調製に使用したガラス器具を保持していなかったため、適切な裏付けのエビデンスなしに、OOSの結果をピペット操作のエラーまたは誤った希釈のせいにした。さらに、貴社は、元のサンプルXXでなく、XXのサンプルを再試験した。貴社は、製造工程のレビュをするための調査XXを開始することを怠り、CAPAを開始しなかった。ロットXXは再試験の合格結果をもとにリリースされた。

B.2020年3月19日、医薬品XXロット11900228ESのCHGに関する調査OOS2-0099-NYが開始された。
2020年3月25日、貴社は、オリジナルのサンプルの貯蔵液のXXをXXし、XXとXXの2つの追加のOOSの結果を報告した。貴社の試験の調査は、OOSの結果に関し、理由とする試験の根本原因を文書化しなかった。貴社は約XXのXXを再試験した。これらのXXの結果は規格内だった。
2020年7月17日、貴社のQUは、最初のOOSの結果が得られた約4か月後この調査を完了にした。
貴社は裏付ける証拠もなく、最初のOOSの結果は、分析者とHPLCの機器の中の分析のばらつきによると結論づけた。また、同じHPLCの装置を使って分析されたその他のロットのアセスメントを実施しなかった。貴社は、製造工程をレビュするためのXXの調査を開始することを怠り、CAPAを開始せず、その他のロットが影響を受けたかどうか判断しなかった。

C.OOSの結果が得られた後、医薬品XXロット11800257JSに関する調査OOS20-0210-NYが開始された。
2020年3月19日、貴社は、CHGの分析に関し、誤った合格の分析値XX(規格XX)を報告した。XXに、貴社の品質管理部門は試験結果をレビュし、試験結果XXは誤って計算され、その結果はOOSで、XXと判断されているべきであった。
2020年6月19日にOOSの調査が開始された。貴社は根本原因を分析者によりされた計算エラーのせいにした。2020年6月23日と2020年8月12日に、新しいサンプルが試験され、合格の結果が得られた。貴社は最初のOOSの結果を無効にし、先延ばしの説明もなしに、OOSの調査が開始された2か月の2020年8月19日に調査を完了にした。貴社は、製造工程をレビュするためにXXの調査を開始することを怠り、CAPAを開始せず、その他のロットが影響を受けたかどうか判断しなかった。
さらに、2021年7月16日に当局に提出されたNDA21524に関する年次レポートの我々によるレビュで、貴社がXXの間隔でXXの結果を合格と不正確に報告しているのがみつかった。
FAR(Field Alert Report：患者の健康を守るために、販売されている医薬品に関して問題がある場合、FDAに提供するレポート)も年次レポートの修正も当局に提出されなかった。

貴社が実施した３つの調査全てにおいて、科学的に正当な理由もなく、分析エラーがもともとのOOSに関し、最も可能性の高い根本原因とされた。貴社は調査の結論で、製品開発、製造のバリデーション、前に得られた不合格の結果、分析試験方法の包括的な評価を含むXXの製造のレビュやCAPAを開始することを怠った。
貴社の回答は不十分である。貴社は、可能性のある根本原因を示したが、試験のエラーが発生していたという貴社の結論を裏付ける科学的なエビデンスに欠けていた。貴社は、適切なCAPAを開始することも怠った。リリース試験に関してOOSの結果があったロットが再試験の合格の結果に基づきリリースされた。
OOSのロットの安定性のタイムポイントに関し、出荷された他のロットが不具合に関連しているかどうかを判断する評価もなかった。さらに貴社の回答は、OOSの結果が不適切に無効化されたかどうかの評価をしていなかった。(2019年5月5日から2021年5月4日に、およそ78のOOSの結果のうち約55が無効化された)
我々は、OOSの試験結果XXの調査に関連する標準操作手順(SOP)を改訂している貴社の努力を認識している。しかし、改訂されたSOP XXの9版には不備が残っている。手順は、OOS XXの調査が、いかに、そして、いつ開始されるべきかが明確ではなく、試験のエラーにより無効化されたOOSの結果が明確なエビデンスのみに基づくことを保証していない。
また、貴社の回答は、OOSの調査がタイムリーな方法で確認され処理されることを保証するための貴社の品質システムの包括的なアセスメントを含んでいない。
不合格、OOS、傾向外(OOT)、または、その他の予期しない結果の取り扱いと、貴社の調査の文書化に関する情報については、
FDAのガイダンス文書Investigating Out-of-Specification(OOS) Test Results for Pharmaceutical Production
を見よ。
我々は、貴社がFDA-483で挙げられたOOSの調査に関するCAPAを実装しようとしていることを認識している。しかし、貴社のCAPAの計画は、出荷のためにリリースされた上記のロットに関して提案されたアクションと、現在アメリカ市場にあるロットの品質が損なわれていないことを保証するための保管サンプルの試験が含まれていない。
さらに、我々は、分析の規格を満たさなかったポピドン-ヨウ素の複数のロットの自主回収を開始するという貴社の判断を認識している。しかし貴社は、同様に分析規格を満たさなかった他の製品XXに回収の範囲を広げなかった。
貴社は回答の中で以下の情報を提供せよ：

  • 逸脱、不一致、苦情、OOSの結果、不具合の調査に関する貴社の全体的なシステムの包括的で独立したアセスメント
    このシステムを改善するための詳細なアクションプランを提出せよ。貴社のアクションプランは、これに限定されないが、調査の能力、範囲の決定、根本減員の評価、CAPAの効果、QUの監視、文書化手順の大幅な改善を含むべきである。調査の全ての段階が適切に実施されることを貴社がいかに保証するかについて検討せよ。
  • OOSの試験の調査がいつXXの調査(例：製造及びサンプリングの手順のレビュ、追加の試験、調査結果の説明、CAPAの開始)を始動させるかについて述べた改訂された手順を提出せよ。
  • アメリカ向け製品で現在アメリカ市場にあり、過去3年の査察の初日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)の結果の回顧的で独立したレビュと、各OOSに関し以下のことを含む分析結果をまとめたレポート：
    • 無効化されたOOSの結果に関する科学的に正当な理由やエビデンスが、決定的または決定的でない状態でも原因となる試験のエラーを証明しているかどうかを判断せよ。
    • 試験の根本原因を最終的に証明した調査に関し、論理的根拠を提供し、改善のために同じまたは同様の根本原因に対して脆弱なその他の全ての試験方法が特定されていることを保証せよ。
    • 回顧的レビュで試験が根本原因であると特定されていないか、根本原因でないとわかった全てのOOSの結果について、製造の徹底的なレビュ(例：バッチレコード、製造手順の妥当性、装置/設備の適合性、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。
      各調査に関し、可能性のある製造の根本原因と、製造作業の改善のサマリを提出せよ。
  • 使用期限内の全ての医薬品のロットの保管サンプルの試験から得られた結果のサマリ
    貴社はこれに限定されないが、各ロットの有効成分の同一性と濃度を含む、全ての適切な品質特性を試験すべきである。もし、試験でOOSの結果が発生したら、顧客への通知や自主回収の開始を含む、貴社がとろうとする是正処置を示せ。

●Field Alert Report違反

査察で、貴社がNDA21524のもとで、出荷されたロット12000124, 11900228ES, 11800257JSに関する不合格の分析結果に関し、21 U.S.C 355(k)の505(k)に要求されている通り、21 CFR 314.81(b)(1)(i),(ii)に則ってFDAにNDA FARを提出することを怠ったことが明らかになった。申請者は、出荷した医薬品内に、細菌学的汚染や、重大な化学的・物理的・またはその他の変更や劣化、または、出荷された1つかそれ以上のロットが申請書内で制定された規格を満たさない不具合に関する情報を受領後3営業日以内に提出することが求められている。
21 CFR 314.81(b)(1)の目的は、既に出荷された医薬品による潜在的な安全上の危険を防ぐため、申請保有者により重大な問題について当局に注意喚起がされるように、早期の警告システムを確立することにある。
我々は貴社にXXに関して確認された全てのOOSの事象の回顧的なレビュの実施と、既に出荷され、21 CFR 314.81(b)(1)に従ってFARが提出されるべきだが当局に提出されていないロットのアセスメントの実施を求める。
貴社はSOPを開発し、SOPの実装とFARの取り扱いに関する手順と責任の詳細について関連する全ての従業員への適切な教育を実施しなければならない。

●CGMPコンサルタントの推奨

貴社の是正の不履行を含む、我々が貴社で発見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 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。

●医薬品の回収

2021年7月18日、XXを販売しているXX社は、貴社により報告されたOOSの分析試験結果により当局にFARを提出し、医薬品XXの自主回収を開始した。

●ポピドン-ヨウ素の製造停止

我々は、貴社がこの製造所でのポピドン-ヨウ素の製造の中止を約束したと認識している。この文書への回答の中で、貴社が今後この製造所でアメリカ市場向けにポピドン-ヨウ素の医薬品の製造を再開するつもりかどうかを明白にせよ。
もしアメリカ市場向けにポピドン-ヨウ素の医薬品の製造を再開することを計画するなら連絡せよ。

●結論

この文書で挙げた違反は、貴社の製品に関し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。
もし貴社が貴社の製造所で製造される医薬品の供給の断絶につながる可能性のあるアクションを検討している場合、すぐに連絡せよ。
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/professional-disposables-international-inc-617201-01072022

まとめ

いかがでしたでしょうか。

  • 出荷した物の返品が発生した際の手順の不備
  • プロセスバリデーションの不備
  • 試験方法のバリデーションの不備
  • 安定性試験実施の不備
  • 品質管理部門の不備
  • OOSの調査の不備

に関し、具体的な指摘があがっていました。
是非、皆様の業務の参考にしていただければ幸いです。

弊社サービスのプロス

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【発行責任者】

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