【最近のウォーニングレター】ASTROM通信 259号

最近のウォーニングレターの概要

■Warning Letter 320-23-04■

2022年5月12日～5月20日のインド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11月22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、ロットやその成分の、説明のつかない規格との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１詳細＞

Ａ．貴社の不合格のロットの調査は、他のロットや、錠剤圧縮機、薬剤の濃度、錠剤圧縮機の設定まで範囲を広げることを怠った。
2018年から2021年に、貴社は、0.1mgおよび0.2mgの濃度の酢酸デスモプレシン錠のXX及び含量均一性試験の規格外の結果(OOS:Out-of-Specification)により、14ロットを不合格にした。
貴社は、2つの濃度の不具合の根本原因を分析するために、層別解析のサンプリングを実施し、追加でテストロットを製造した。貴社は、酢酸デスモプレシン錠0.1mg、ロット20210776について、錠剤圧縮のパラメータの定義の不足が含量均一性の不具合のせいであると考えたが、同じXX工程や圧縮装置を使用した他のロットや製品の試験を実施することを怠った。
貴社は回答の中で、0.1mgおよび0.2mgの酢酸デスモプレシン錠のロットが不合格になり、0.2mgの濃度の錠剤について、錠剤圧縮のパラメータの是正処置を適用しなかったことを認めた。この査察の結果、貴社は回顧的レビュを実施し、酢酸デスモプレシン錠0.2mg、ロット20220121の層別解析サンプルの分析結果の不具合を発見し、2022年6月10日にこのロットの自主回収を開始した。しかし、貴社の回答は、問題発生時の分析の不具合と、市場への影響の調査の不履行に適切に対処しておらず、貴社の調査の全ての段階の改善のための全体的な管理戦略は含まれていなかった。

この文書への回答の中で、以下の情報を提供せよ：

・逸脱、不一致、苦情、OOSの結果、不具合を調査するためのシステム全体の包括的で独立したアセスメント
　これに限定されないが、調査能力、調査範囲の決定、根本原因の評価、是正処置・予防処置（CAPA）の有効性、品質の管理、文書化された手順の大幅な改善を含むこのシステムの改善のための詳細なアクションプランを提供せよ。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検討せよ。

・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
　プログラムが効果的な根本原因の分析を含み、CAPAの有効性を保証し、調査の傾向を分析し、必要に応じてCAPAプログラムを改善し、品質保証の最終的な決定を実施し、経営陣によって完全にサポートされているかどうかを評価するレポートを提供せよ。

●指摘２

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及び工程管理のための文書化された手順を制定することを怠った。(21 CFR 211.100(a))

＜指摘２詳細＞

貴社はXXゲルXX%の製造工程を適切にバリデートすることを怠った。具体的には、貴社のプロセスバリデーションは、XXゲルXX%のロット間及びロット内のばらつきの評価が不足している。貴社のこの医薬品に関する初回の工程の性能適格性評価は、3つのバリデーションロットの充填のXXで収集されたチューブから採取された粘度について、XXのランダムなチューブを試験しただけだった。この検証はロット内のばらつきを評価しておらず、バリデーションレポート内には、XXチューブがどこで収集されたか述べていなかった。粘度に関するこのサンプリング計画は、貴社の工程性能の統計的な信頼性を得られない。
2回目の工程の性能適格性評価の検証は、医薬品の粘度を管理するために使用される重要な添加剤の適格性を評価するために実施された。検証は1ロットだったため、工程が一貫して高品質の医薬品を製造することを保証するためのロット間のばらつきは評価できなかった。貴社は、XXゲルXX%の粘度の規格の不適合により2020年から2021年の間に5ロットを不合格にした。

この文書への回答の中で以下の情報を提供せよ：

・継続的な管理状態を保証するためにロット間及びロット内のばらつきの慎重なモニタリングを含む、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。

・製品のライフサイクルを通じて、関連する手順と共に、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工程の性能適格性評価、継続的な管理状態を保証するためのロット間及びロット内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。

●指摘３

貴社は、必要な試験管理の方法を制定し、それに従うことを怠った。(21 CFR 211.160(a))

＜指摘３詳細＞

貴社は、クロマトグラフィーのピークの積分と、クロマトグラフィーのデータ処理のレビュに関する適切な手順を持っていなかった。

Ａ．我々査察官は、貴社が、適切な手順の管理や正当化の理由もなく、処理方法や合格結果の報告に、指定時刻の積分の結果を手動で入力している事例を特定した。貴社の分析者は、錠剤XXロットXXの不純物XXのピークのクロマトグラフィーのデータの処理を手動で変更した。自動積分処理が標準やその他のピークと同じ方法で適用されていたら、不純物の結果はリリースの規格を満たしていなかっただろう。
さらに、貴社のクロマトグラフィーデータの積分手順は、いつ分析者が手動で指定時刻の積分結果を入力できるか、これらの結果はどのように使用されるべきか、それらがどのようにレビュされるべきかを示していないので、不適切である。手順は、指定時刻の積分結果の手動入力の監督承認、もともとシステムが積分したクロマトグラムのレビュと、指定時刻の結果を手動で入力するための正当化の理由を必要としていない。
貴社は回答の中で、使用期限内のアメリカ向けロットについて実施した回顧的レビュを通じて、既存のクロマトグラフィーデータの処理手順を使って実施した積分の精度をレビュした。貴社は、錠剤XXとXX、ロットXXについて、不特定の不純物に関する追加の規格外の結果を確認した。報告された結果はXX％で、「リフトオフ％の設定」と「タッチダウン％の設定」として確認された指定時刻の積分の結果を削除した後に再処理された結果はXX%で、未知の不純物について規格外である。(リリース規格は、XX%以下)
貴社は、再処理されたOOSの結果を、ノイズの多いベースラインのせいにした。しかし、貴社の調査は、その結論を裏付けるデータに欠けていた。調査報告は、フルスケールのクロマトグラフィーの実行、積分パラメータやサンプル標準及びブランクのクロマトグラムの情報を含んでいなかった。
これらのクロマトグラムは貴社の調査報告の中になく、説明もなかった。調査報告の中には、初期処理時の装置の準備状態を保証するためにシステムの適合性が満たされているかの説明もない。
さらに、初期処理中にピークを無視するために使用される最小面積が適切に計算されていなかった。
貴社の手順に従った正しいXXの代りに、XXの最小面積が適用された。再処理の後、追加のピークは見つからなかった。さらに、貴社の結論は、繰り替えし試験の中の同じピークの存在を説明することを怠り、強制分解試験の情報を提出しなかった。
貴社は、クロマトグラフィー試験の対象となる原材料、有効成分、医薬品に関連する全てのクロマトグラフィーデータの回顧的レビュの実施を約束しなかったので、貴社の回答は不十分である。

Ｂ．関連物質のピーク積分のための最小面積設定のための計算は記録されていないか、品質部門によってレビュされていない。査察中、分析者は、錠剤XXロットXXの最小面積を計算するよう依頼された。分析中に使用された最小面積は正しく計算されていなかった。最小面積の変更は報告結果を変化させなかった。しかし、計算が記録されていないため、誤った最小面積が計算され、分析に使用されたかどうかをレビュで検知できなかった。クロマトグラフィーの分析において関係する必要なピークが積分されたかどうかの保証が不足している。
貴社は、実際に計算された最小面積に対して処理の中で使用された最小面積を検証するためにアメリカ向け医薬品について回顧的レビュを実施し、使用された最小面積が、計算された最小面積より大きい多数の医薬品のサンプルが特定された。しかし、規格外の結果はみつからなかった。
有効成分等の原材料を含む関連物質の最小面積の設定に関する全てのクロマトグラフィーデータの回顧的レビュを実施することを約束しなかったので、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　貴社によって使用される全ての試験方法が適切な指示と方法の適合性の基準を持ち、目的に適合しているかどうかを判断するために適切にバリデートされていることを保証するため、それらのアセスメントを含めよ。このレビュに基づき、貴社の試験システムを改善し、その効果を評価するための詳細な計画を提出せよ。
・貴社全体のCAPAの詳細を含む貴社の経営戦略
　詳細な是正処置計画では、微生物及び分析のデータ、製造記録、FDAに提出される全てのデータを含む、貴社で生成される全てのデータの信頼性と網羅性をいかに保証するつもりか述べる必要がある。
・錠剤XXとXXの分析方法のバリデーション報告書のコピー方法のバリデーションが、手動の積分と商用ロットにおけるこの手順の合理性を含んでいたかどうかを示せ。
・錠剤XXとXXの強制分解の検証のコピー

●指摘４

貴社は、製造された医薬品の各ロットの製造と管理に関する情報を含むロットの製造指図記録を作成することを怠った。(21 CFR 211.188)

＜指摘４詳細＞

貴社の製造記録は不完全で、圧縮機の不合格のリミットに関するロット固有のデータを含んでいなかった。
製造オペレータは、貴社の手順で要求されている通りにロット固有の不合格のリミットを計算する代わりに、錠剤圧縮の処方で初期値として事前設定された不合格値を使用したことを認めた。
不適合な錠剤と硬度の規格を満たしていない錠剤の調査があった。それぞれの調査の影響アセスメントで、自動重量制御または圧縮力制御がオンになっているので、規格を満たさない錠剤が見つかるリスクは低いと結論づけた。
しかし、調査は、不合格のリミットが適切に設定されていたかどうか判断しなかった。圧縮機が規格を満たさない錠剤を正しく拒否していたかを確認するための保証が不足していた。
貴社は、製造所で製造された全ての錠剤に関して制定された圧縮機のパラメータに関する検証プロトコルを開始した。しかし、貴社の回答は不十分である。貴社は、アメリカに出荷された使用期限内のすべてのロットについて、不合格のリミットが適切に計算されて入力されたことを保証するための、PLC（Programmable Logic Control）の処方データをレビュしなかった。

この文書への回答の中で、以下の情報を提供せよ：

・全ての医薬品の製造ライフサイクルを通じて継続的な経営陣の監督をより確実にするための改善計画　工程のばらつきの原因を特定し、製造及び包装作業の両方を含む製造が適切なパラメータと品質基準を満たすことを保証する、よりデータ駆動型で科学的に理にかなったプログラムを提出せよ。プログラムはこれに限定されないが、装置の使用目的への適合性の評価、投入原材料の品質の保証、各製造工程の段階とその管理の能力と信頼性の判断、工程の性能と製品品質の慎重で継続的な監視を含むべきである。

●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。
貴社の施設で生産される医薬品の供給に支障をきたす可能性のある措置を検討している場合、直ちにCDERの医薬品不足スタッフに連絡せよ。

出典：https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/glenmark-pharmaceuticals-limited-637314-11222022

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■Warning Letter 320-23-05■

2022年6月20日～6月24日のカナダ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11月28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、ロットやその成分の、説明のつかない規格との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１詳細＞

貴社は、流通していないオンデマンドのシステムXXから採取されたサンプルを適切に調査することを怠った。サンプルは貴社の医薬品XXの製造前にとられていた。サンプルは、バイオバーデンはXXCFU/mL(規格はXXCFU/mL以下)の高い値を得た。貴社は、根本原因の判断の文書化、回収された微生物に基づく種の分析や製品への影響のアセスメントを実施せずに医薬品XXを出荷した。
さらに、貴社は貴社のXXロットXXの使用以来炎症が発生したという顧客の苦情を適切に調査することを怠った。貴社の調査は、全員貴社の従業員でXXを使用した4名の参加者によるパネル試験の実施だった。
貴社の従業員たちがXXの使用後にアレルギー反応を示さなかったと結論を出した後、貴社は更なる調査は必要ないと判断した。そのロットの追加の試験や評価は実施されなかった。
貴社は回答の中で、苦情及び逸脱の管理に関する標準操作手順書(SOP)を改訂すると約束した。
貴社は、調査が包括的で適切なリスクアセスメントが実施されていることを保証するために、前の調査(貴社のXXの少なくとも2ロットに関連した調査を含む)の回顧的レビュを実施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、貴社は、適切な根本原因を決定し、再発を防ぐために適切な是正処置・予防処置(CAPA)が確認され実施され、CAPAの効果が測定されるためにいかに調査システムを修正するかについて説明しなかった。
不十分な調査は、不適合の根本原因を特定または軽減しないことにつながる可能性があり、安全で効果的な医薬品の一貫した製造を保証できない。
不合格、OOS、傾向外、または、他の予期しない分析結果の取り扱いや、貴社の調査の文書化についての更なる情報については、FDAのガイダンス文書を参照せよ。

この文書への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システム全体の包括的で独立したアセスメント
　このシステムを修正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、調査者の能力、調査の範囲の決定、根本原因の評価、CAPAの効果、品質の監視、文書化された手順の著しい改善を含めるべきである。貴社が調査の全てのフェースが適切に実施されていることをいかに保証するかについて検討せよ。
・XXのロットXX及びXXのリスクアセスメント

●指摘２

貴社は、成分、医薬品の容器、蓋、工程内原料、ラベル、医薬品が、同一性、濃度、品質、純度の適切な基準に従う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の管理を定めることを怠った。(21 CFR 211.160(b))

＜指摘２詳細＞

貴社は、貴社の全ての非滅菌医薬品の微生物試験及び規格を含む適切な試験の管理を定めることを怠った。例えば、貴社は、貴社の手の除菌用ジェル医薬品の微生物試験をリリース前に実施することを怠った。さらに、貴社の医薬品XXについては、微生物試験は実施されたが、一般生菌数の規格が製品の使用目的に適していない。
貴社は回答の中で、微生物試験の手順と規格を改訂することを約束した。貴社は、前に出荷した医薬品が改訂した微生物の試験手順と規格を満たすことを保証するための計画を提出しなかったので、貴社の回答は不十分である。貴社の回答は、既に出荷された医薬品が改訂された微生物試験の手順や規格を満たさなかった場合にとる予定のアクションを含んでいなかった。

この文書への回答の中で以下の情報を提供せよ：

・貴社の各医薬品の微生物学的に適切なロットのリリース規格（例：総菌数、セパシア菌群好ましくない微生物を検知するためのバイオバーデンの確認）；貴社のXXシステムで使用されている総菌数及び好ましくない微生物に関する現在のアクション/アラート限界
・貴社の各医薬品を分析するために使用される全ての微生物試験の方法とXXシステム
・使用期限内にある全ての医薬品の保管サンプルの試験から得られた結果のサマリ
　貴社は各ロットの微生物の品質(総菌数と好ましくなく微生物を検知するためのバイオバーデンの確認)を試験すべきである。試験でOOSの結果を得たら、顧客への通知や回収の開始を含む、貴社がとろうとしている是正処置を示せ。
・査察終了以降のXXシステムの全ての結果のサマリ

●指摘３

貴社は、各成分について、同一性と、純度、濃度、品質に関する文書化された全ての規格への一致について試験することを怠った。(21 CFR 211.84(d)(1), 21 CFR 211.84(d)(2))

＜指摘３詳細＞

貴社は、有効成分であるエタノールを含む貴社の手の除菌用医薬品の製造に使用される各成分について適切な同一性試験を実施することを怠った。さらに、貴社の有効成分であるエタノールは、メタノール含有量について試験されず、貴社の手順は、ジエチレングリコール(DEG)の存在についてグリセリンを試験することを保証していなかった。
貴社は回答で、成分の試験手順と規格を改訂することを約束した。貴社は、過去に出荷された医薬品が、改訂された同一性試験及び純度試験の要求を満たす入荷成分で製造されたことを保証するための詳細な計画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。
成分試験は品質の基本である。適切な試験をせずに、入荷した成分が、医薬品の製造に使用する前に、適切な規格に従うという科学的なエビデンスを貴社は持っていない。

◇エタノールを含む製品

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メタノールの使用は、世界中の人々にさまざまな致命的中毒事件をもたらしてきた。
エタノールを含む医薬品を製造する場合、貴社がCGMPの要件を満たす助けとして、FDAのガイダンス文書Policy for Alcohol (Ethanol) and Isopropyl Alcohol for Methanol, Including During the Public Health Emergency (COVID-19)を見よ。

◇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)で汚染されたグリセリンの使用は、世界中の人々にさまざまな致命的中毒事件をもたらしてきた。
グリセリンを含む医薬品を製造する場合、貴社がCGMPの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。

この文書への回答の中で以下の情報を提供せよ：

・製造に使用するために入荷した成分の各ロットを試験しリリースするのに使用している化学及び微生物学的品質管理の規格
・同一性、濃度、品質、純度の全ての規格への一致について、貴社が各成分をいかに試験するかの記述　もし濃度、品質、純度について各成分を試験する代わりに、貴社の供給者の分析証明書(COA)の結果を受け入れるつもりであれば、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、貴社の供給者の分析結果の信頼性をいかに確実に立証するつもりか明記せよ。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約束せよ。
・各成分の製造業者から得たCOAの信頼性を評価するために、全ての成分の試験から得られた試験結果のサマリ
　このCOAのバリデーションプログラムを述べた貴社のSOPも提出せよ。
・貴社が製造した医薬品を試験する、契約施設の適格性評価と監督のための貴社のプログラムのサマリ
・メタノール、XX、XX、XXとリリースされ出荷された手の除菌用医薬品の全てのロットに関する試験結果

●医薬品の製造中止

アメリカ市場向けの手の除菌用医薬品の製造を中止するという貴社の約束を認める。この文書の日付時点で、貴社の手の除菌用医薬品は、FDAのリストにのっている。さらに、貴社がこれらの医薬品の製造を中止するという貴社の決定をFDAに伝えた後、貴社の手の除菌用医薬品の積み荷がアメリカに入ってきた。
FDAはそれ以来貴社に輸入警告措置66-40をとった。
この文書への回答の中で、貴社が手の除菌用医薬品の製造とアメリカ向けの出荷を止めるつもりかどうかを明確にせよ。これらの医薬品の製造と販売を中止するつもりなら、既にリストにのっている全ての手の除菌用医薬品をリストから除外せよ。

●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、もし貴社がアメリカ市場向け医薬品の製造を再開するつもりであれば、貴社は、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べきである。また適格性のあるコンサルタントは、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、CGMPの遵守について貴社の製造作業全体の包括的な監査を実施し、是正処置・予防処置の完了と効果を評価するべきである。
貴社のコンサルタントの使用は、CGMPを遵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遵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FDAは2022年10月28日に輸入警告措置66-40をとった。
全ての違反を速やかに是正せよ。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/ag-hair-limited-638646-11282022

まとめ

いかがでしたでしょうか。
今回取り上げた2件のウォーニングレターは、手順や規格の制定の不備、不具合等が発生した際の調査不足といった、目新しくない指摘が多かったように思います。
こういう一般的な内容ほど、自己点検で見落としがちなのかもしれません。

☆次回は、2/15（水）に配信させていただきます。

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