【最近のウォーニングレター】ASTROM通信 255号

今年も残すところあと一ヶ月となりましたが、いかがお過ごしでいらっしゃいますか？
さて今回は、久々に、アメリカ食品医薬品局(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。

■Warning Letter 320-22-24■

2022年2月16日～2月18日のドイツ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9月9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ついての文書化された手順を制定することを怠った。貴社は、装置の洗浄及びメンテナンスのための文書化された手順を制定しそれに従うことも怠った。(21 CFR 211.100(a)、211.67(b))

＜指摘１詳細＞

〇プロセスバリデーションの欠如

貴社は、貴社のOTC医薬品の製造工程がバリデートされていることを示すためのデータを提出することを怠った。査察中、貴社は、製造された各OTC医薬品が、予め定められた品質要件を一貫して確実に満たすことを裏付けるための文書を提出できなかった。また、貴社は所定の製造工程が管理状態にあることを保証するために実施された活動の記述を伴う、制定された合格基準が満たすことを示す適格性評価のプロトコル、報告、検証文書が欠けていた。
さらに、プロセスバリデーションが不足しているために、貴社のバッチレコードには、重要な製造の情報が含まれていないので不適切である。例えば、ロットXX、XX、XXのXXに関するバッチレコードは、XX回、XX、工程内の確認やサンプル等のXX工程の情報が欠けていた。査察中、貴社は、全てのXX装置には、製造中にオペレータによって手動で調整される可変のXXがあるが、操作XXは貴社の製造記録に文書化されていないと述べた。
貴社は回答の中で、プロセスバリデーションを支援するための第三者を雇うと約束した。また貴社は、貴社の製造記録書を改訂するつもりであると述べた。
貴社の回答は不十分である。貴社は、さまざまな製造工程のバリデーションのための工程性能プロトコルと、ばらつきの全ての原因を特定するために実施されるアクションの詳細を提出することを怠った。
さらに、貴社は、XXのバルクのホールドタイムに従っているが、バルクのホールドタイムの検証が不足していた。貴社は回答の中で、貴社の設備で製造される医薬品のバルクのホールドタイムをバリデートすると約束した。貴社は貴社の医薬品の品質を保証するために製造段階でいかに時間の制限を制定するかの十分な情報を提供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、バルクのホールドタイムの検証の不足が貴社の医薬品の安定性や品質特性に与える可能性の影響を判断するための製造作業の回顧的評価を含めなかった。

〇洗浄バリデーション

XXとXXを含む医薬品XXとXX等の貴社のOTC医薬品は、軟膏、XX、XXを含むかもしれないXX等の非医薬品を製造するために使用されるのと同じ装置で製造されている。
貴社は、洗浄の対象の最悪の物質としてXXを特定した。XXに関する安全データシートは、その物質を、飲み込んだら有害であると記載している。貴社の医薬品はXX用であり、意図しない摂取の危険があることに注意せよ。貴社の医薬品の洗浄バリデーションプログラムに関して提出された情報は不十分である。非医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、CGMP上受け入れられない。

この文書への回答の中で、以下の情報を提供せよ：

・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バリデーションプログラムの関連
　手順を添えた、詳細なサマリ
　工程性能の適格性評価と、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製品についての、工程性能適格性評価(PPQ)の実施に関するタイムライン
・工程性能プロトコル、装置及び設備の適格性評価に関する文書化された手順を提供せよ。
・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、メンテナンス、管理、モニタリングに
　関する詳細なプログラムを提供せよ。また、貴社の装置及び施設の適格性評価に関する
　プログラムも含めよ。
・非医薬品と共有された装置で以前に製造された全ての医薬品のリスクアセスメント
　各製品について、共有装置による潜在的な汚染のリスクを評価し、まだ販売中の全ての製品に
　ついて、回収の可能性や市場からの撤退を含む、製品品質や患者の安全性のリスクに対処する
　ための計画を提出せよ。
・貴社の設備の、医薬品及び非医薬品の両製造に関する貴社の計画
　もし貴社が、貴社の設備で医薬品及び非医薬品の両製造を継続するつもりであれば、医薬品
　製造のための専用製造装置を維持するエリアを分離するための計画と、工業用製品の製造作業
　についての情報を提供せよ。
・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。
・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
　〇洗浄前の最大ホールドタイム

　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標準操作手順（SOP）のサマリ
・洗浄手順と実務の適切な改善、完了までのタイムラインを含む、貴社の洗浄プログラムの
　回顧的なアセスメントに基づくCAPAの計画
　装置洗浄のライフサイクル管理に関する貴社の手順の脆弱性の詳細を提出せよ。洗浄効果の
　増大、全ての製品と装置に関する適切な洗浄の実施の継続的な検証の改善、その他全ての
　必要とされる改善を含む、貴社の洗浄プログラムの改善について述べよ。
貴社には、プロセスバリデーションのプログラムが欠けている。プロセスバリデーションは、
ライフサイクルを通じて、工程の設計の安定性と管理状態を評価する。製造工程の各重要な
段階は、適切に設計され、投入される原材料、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、初期の管理状態が定着しているかどうかを判断する。
商用の販売の前に、工程の適格性評価の達成が必要である。その後、製品のライフサイクルを
通じて、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、工程の性能と製品品質の
継続的で慎重な監視が必要である。

●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、純度の適切な標準に従っ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の管理を確立することを怠った。(21 CFR 211.160(b))

＜指摘２詳細＞

貴社は、貴社のXXシステムがUSPモノグラフ規格の最小値を一貫して満たし、医薬品の製造に適した適切な微生物の限度を管理していることを証明することを怠った。例えば、2021年に、貴社のXXに関するXX試験の結果はUSP基準を超えた。さらに貴社は、XXの規格を持たず、XXのXX試験を実施していない。貴社が、意図した目的に合うXXを一貫して製造するためにXXシステムを設計することが不可欠である。貴社は回答の中で、確実にUSPの標準を満たすために、XXの供給を外部委託する意向を述べた。不適切なXXシステムを使って製造されリリースされた医薬品のリスクアセスメントを含んでいなかったので、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：

・このシステムが、貴社の各製品の使用目的に合ったXXを製造しているかどうかをモニタする
　ための微生物総数の限界
・XXシステムで見つかった不具合が、現在アメリカに流通しているか、使用期限内のすべての
　医薬品のロットの品質に与える潜在的な影響に対処するための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、貴社がとろうとしている、顧客への通知や製品の回収と
　いったアクションを明記せよ。
・システムが、XXやUSPモノグラフ規格や微生物の限度を満たすXXを一貫して製造することを
　保証する、継続的な管理、メンテナンス、モニタリングに関する貴社のプログラムを管理
　する手順
・XXシステムの設計、管理、メンテナンスに関する包括的な改善計画
・XXシステムのバリデーション報告
　システム設計及び継続的な管理とメンテナンスに関するプログラムに対してなされた全ての
　改善のサマリを含めよ。

●指摘３

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３詳細＞

貴社は、貴社の医薬品を製造するのに使用される、入荷した有効成分の同一性を判断するための試験を実施することを怠った。我々査察官は、XXの同一性試験をせずに、製造で使用するために原薬XXをリリースしているのを見た。各成分のロットの同一性試験は、医薬品の製造に使用する前に必要であり、適切な間隔で供給者の試験結果をバリデーションすることで、その他の成分の属性に関する分析証明書(COA)を信頼できる。
貴社は回答の中で、貴社は、XXの同一性試験を実施するための装置を持っていないと述べた。
また、貴社は、サードパーティのラボにて、使用された原薬の保存検体の試験を実施することを約束した。
貴社の回答は不十分である。貴社は、貴社の原材料システムの包括的な改善、既にリリースされ出荷された製品のアセスメント、サードパーティの試験の完了のタイムラインに関する情報を提出しなかった。

この文書への回答の中で、以下の情報を提供せよ：

・成分、容器、蓋の全ての供給業者が、それぞれ適格であり、原材料には適切な使用期限または
　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で
　独立したレビュ
　レビュには、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
　かを判断することも含むべきである。
・入荷した成分の各ロットを製造に使用するために試験しリリースするの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
・同一性、濃度、品質、純度の全ての規格への一致について、入荷した成分の各ロットを貴社が
　いかに試験するつもりかの記述
　もし貴社が濃度、品質、純度に関し各成分を試験する代わりに、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じて、
　いかに確実に供給者の分析結果の信頼性を確認するかを明記せよ。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。
・成分の各製造業者から得た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について述べた貴社のSOPも含めよ。

●指摘４

貴社は、許可された職員のみが製造指図記録書原本やその他の記録の変更を行えることを保証するために、コンピュータまたは関連システムに対し適切な管理を実施することを怠った。
(21 CFR 211.68(b))

＜指摘４詳細＞

貴社は、フーリエ変換赤外分光計(FTIR)システムの適切な管理を行うことを怠った。例えば、貴社は、各分析者のユニークなユーザ名やパスワードを設定しなかった。さらに、このFTIRは、日常的に原材料や最終製品試験に使用されているにもかかわらず、監査証跡機能が無効になっていた。
貴社の品質システムは、貴社が製造する医薬品の安全性、有効性、品質を裏付けるデータの正確性と完全性を適切に保証していない。CGMPに則ったデータ・インテグリティの手順の制定と遵守のアドバイスとして、FDAのガイダンス文書Data Integrity and Compliance With Drug CGMPを見よ。
我々は、貴社が、貴社の作業を監査し、FDAの要件を満たす手助けをするためのコンサルタントを使っていることを認識している。我々は、貴社の改善を手助けする適切なコンサルタントを雇うことを強く勧める。この文書への回答の中で、以下の情報を提供せよ：

Ａ．アメリカに販売された医薬品のデータレビュの結果を含む、記録及び報告データの不正確さ
　　の範囲の包括的な調査
　　貴社のデータ・インテグリティの欠如の範囲と根本原因の詳細な記述を含めよ。
Ｂ．発見された不具合が貴社の医薬品の品質に与える潜在的な影響の現在のリスクアセスメント
　　貴社のアセスメントは、データ・インテグリティの欠如の影響を受けた医薬品のリリース
　　による患者へのリスクの分析と、継続的なオペレーションによってもたらされるリスクの
　　分析を含めるべきである。
Ｃ．全体的な是正処置・予防処置の計画の詳細を含む貴社の経営戦略
　　詳細な是正処置計画は、微生物データ、分析データ、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た全てのデータの信頼性と完全性をいかに保証するつもりか
　　を記述すべきである。

●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。
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/system-kosmetik-produktionsgesellschaft-fur-kosmetische-gmbh-632727-09092022

■Warning Letter 320-23-01■

2022年4月11日～4月15日の中国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10月5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、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。また貴社は、適切な間隔で、成分の供給者の分析試験の信頼性をバリデートし確証することを怠った。(21 CFR 211.84(d)(1)、211.84(d)(2))

＜指摘１詳細＞

貴社は、アルコール75％手指の除菌用ローションとXXを含む、OTCの手指の除菌用ローションの医薬品を製造している。貴社は、医薬品を製造するために成分を使用する前に、入荷した成分の同一性について試験することを怠った。さらに貴社は、適格性評価がされていない供給者から得た成分の規格に関する分析証明書(COA)を信頼した。同一性、純度、濃度、品質について成分を分析しないことにより、貴社は入荷した成分が規格を満たすことを保証することを怠った。
貴社は回答の中で、貴社の手指の除菌用ローションの製造で使用されている２つの有効成分であるXXとエタノールに関する試験方法を提出した。また貴社は、メタノールが検出できないレベルの２つの除菌用ローションの保存検体の試験結果も提供した。
貴社は、貴社の試験方法が、USPの方法と同等か、USPより良いということを示す、有効成分及び成分の関連する試験方法に関する詳細を提供しなかったので、貴社の回答は不十分である。
さらに貴社は、どのように貴社の供給者のCOAの試験結果の信頼性を確認し定期的にバリデートするか検討しなかった。
この文書への回答の中で、以下の情報を提供せよ：

・現在アメリカ市場にあり使用期限内の医薬品の同一性、純度、濃度、品質、安全性に対する、
　入荷成分の試験の不足の影響の回顧的リスクアセスメント
・入荷した成分のロットを製造に使用するために試験してリリースするのに使用している化学
　及び微生物学上の品質管理の規格
・各成分のロットの同一性、濃度、品質、純度に関する全ての規格への一致をいかに試験する
　つもりかの記述
　各成分のロットの濃度、品質、純度に関して試験する代わりに、供給者の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再バリデーションを通じて、供給者
　の分析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
　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。
・各成分の製造業者の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作業手順書(SOP)を含めよ。
・貴社が製造する医薬品を試験する契約設備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、蓋の全ての供給業者が、それぞれ適格であり、原材料には適切な使用期限または
　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で
　独立したレビュ
　レビュには、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
　かを判断することも含むべきである。

●指摘２

貴社は、装置の洗浄及びメンテナンスの文書化された手順を制定して遵守することを怠った。
(21 CFR 211.67(b))

＜指摘２詳細＞

貴社は、XXやXX等の非医薬品の工業製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を製造している。洗浄中の製造装置からの不十分な残留物の除去は、非専用装置で続いて作られた医薬品の汚染につながる可能性がある。
貴社は回答の中で、製造装置の洗浄と殺菌に関する貴社の手順の概要を述べた文書を提供した。
工業用製品の製造に使用するのと同じ製造装置を使って医薬品製造を続けることは、交叉汚染の
リスクによりCGMP上受け入れられない。
この文書への回答の中で、以下の情報を提供せよ：

・工業製品と共有している装置で以前に作られた全ての製品のリスクアセスメント
　各製品について、共有された装置による汚染の可能性のリスクを評価し、まだ流通中の製品の
　品質と患者の安全のリスクに対処するための、回収や市場からの撤退の可能性を含む、貴社の
　計画を提出せよ。
・貴社の施設で医薬品と非医薬品の両方を製造することに関する貴社の計画
　もし貴社が、貴社の設備で医薬品及び非医薬品の両製造を継続するつもりであれば、医薬品
　製造のための専用製造装置を維持するエリアを分離するための計画と、工業製品の製造作業に
　ついての情報を提供せよ。
・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プログラムが実施されることを
　確実にする改良したSOPのサマリ

指摘３

貴社は、有害な微生物が含まれていないことが求められている医薬品の各ロットについて、必要に応じて、ラボの適切な試験を実施することを怠った。(21 CFR 211.165(b))

＜指摘３詳細＞

貴社のバッチレコードは、貴社の手指の除菌用ローションの最終製品の微生物試験を実施しなかったことを示している。各ロットのリリース前の試験を実施しないので、貴社には、全ての医薬品のロットが適切な微生物の品質規格に従っているという科学的なエビデンスがなかった。
この文書への回答の中で、以下の情報を提供せよ：

・ロットの処遇の判断をする前に医薬品の各ロットを分析するために使用されている試験方法を
　含む化学及び微生物の規格のリスト
　〇この文書の日付時点で使用期限内にあるアメリカ向けに出荷された医薬品の全てのロットの
　　品質を判断するために、保存検体の全ての化学及び微生物の試験を実施するためのアクション
　　プランとタイムライン
　〇使用期限内の各ロットの保存検体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医薬品の基準以下の品質が明らかになった場合、顧客への通知や製品の
　回収などの是正措置を迅速に実施せよ。

指摘4

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ついて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４詳細＞

貴社は、OTCの手指の除菌用ローションの製造工程のバリデーションを怠った。例えば貴社は、これに限定されないが、XXや時間を含む重要な製造の変数を十分に特定していなかった。貴社は、均一な特性と品質の医薬品を一貫して製造できるように製造工程が管理されていることを証明しなかった。
貴社は回答の中で、2022年4月18日以降に実装されるOTCの手指の除菌用ローションの製造工程の手順を提出した。
貴社の回答は不十分である。貴社は、貴社の医薬品を製造するために使用する工程をバリデートするかどうかについて言及していない。
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と通して管理状態を保証するための、関連手順も添えた貴社のバリデー
　ションプログラムのサマリ
　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内及びロット間のばらつき
　を継続的にモニタリングするための貴社のプログラムについて述べよ。
・医薬品の出荷前に適切なバリデーションの実施を確実にする方法を含む、販売されている貴社
　の各製品の工程性能適格性評価を実施するためのタイムライン
　FDAがプロセスバリデーションの要素と考える一般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5

貴社の品質管理部門は、製造された医薬品がCGMPに従い、同一性、濃度、品質、純度に関して制定された規格を満たすことを保証するためにその責任を果たすことを怠った。(21 CFR 211.22)

＜指摘５詳細＞

貴社の品質部門(QU)は貴社のOTC医薬品の製造を適切に監督しなかった。例えば：

・貴社のバッチレコードは、医薬品のリリースの日の情報がなく、QUによって署名されていなかった。
・貴社のQUは貴社の電子システム内でラボの試験結果を見つけることができず、電子データのバック
　アップが不十分だった。
・XXに関するラボノート内に記録された試験結果は判読できず、記録は帰属可能でなかった。
・我々査察官がXXに関すCOAを要求した時、貴社は査察官に食品グレードのCOAを提出した。

医薬品の品質を一貫して保証するために、全ての製造作業のQUによる適切な監督が必要である。貴社は回答の中で、QUの責任、記録の管理手順、製造記録書のフォーム、XXの記録フォーム、製造記録の管理システムを説明したいくつかの文書を提出した。

貴社は、これらの不備につながった貴社のQUの根本的な欠陥に対応することを怠ったので、貴社の回答は不十分である。貴社の回答は、製品品質を保証するために、適切な運用プログラム、システム、データガバナンス、関連手順を制定していることを示す文書と十分な記述が不足していた。
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めるべきである：
　○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によるロットの処遇の判定前の、各ロット及びそれに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　　の業務の遂行

・文書手順が不十分かどうかを判断するための、貴社の製造及び試験作業を通して使用されている
　文書システムの完全なアセスメント
　貴社が貴社の業務を通して、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。

貴社の品質システムは不十分である。CGMPの規制の21 CFR Part 210,211の要件を満たすために、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。

●データ・インテグリティの改善

貴社の品質システムは、貴社が試験した医薬品の安定性、有効性、品質を裏付けるデータの正確性と完全性を適切に保証していない。CGMPに従ったデータ・インテグリティの手順を制定し遵守するための助けとして、FDAのガイダンス文書Data Integrity and Compliance with Drug CGMPを見よ。

この文書への回答の中で、以下の情報を提供せよ：

Ａ．アメリカに販売された医薬品のデータレビュの結果を含む、記録及び報告データの不正確さの
　　範囲の包括的な調査
　　貴社のデータ・インテグリティの欠如の範囲と根本原因の詳細な記述を含めよ。
Ｂ．発見された不具合が貴社の医薬品の品質に与える潜在的な影響の現在のリスクアセスメント
　　貴社のアセスメントは、データ・インテグリティの欠如の影響を受けた医薬品のリリースに
　　よる患者へのリスクの分析と、継続的なオペレーションによってもたらされるリスクの分析を
　　含めるべきである。
Ｃ．全体的な是正処置・予防処置の計画の詳細を含む貴社の経営戦略
　　詳細な是正処置計画は、微生物データ、分析データ、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た全てのデータの信頼性と完全性をいかに保証するつもりかを記述すべ
　　きである。

●未承認の新薬と虚偽表示の違反

省略

●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、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、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、コンサルタントが貴社の是正処置・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8月1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/beijing-xinggu-lvsan-technology-co-ltd-formerly-known-beijing-lvsan-technology-co-ltd-633904

まとめ

いかがでしたでしょうか。
今回は2件ともデータ・インテグリティに関する指摘が含まれていました。
1件目は、データを生成するコンピュータの管理に問題があり、データ・インテグリティが保証出来ない状態でした。
また、2件目は、文書作成手順の問題で、データがALCOAの原則を満たしていない状態でした。
耳にタコが出来そうなデータ・インテグリティですが、今一度、自社のデータ管理に不備がないか注意してみるのもよいかもしれません。

弊社サービスのプロス

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【発行責任者】

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