ゴールデンウィークも終わり、梅雨の走りのような天気ようになってきましたが、いかがお過ごしですか。
今回は、アメリカ食品医薬品局（FDA）が2022年3月9日から022年6月7日までコメント募集を行っている品質指標報告プログラム(Quality Metrics Reporting Program)について取り上げたいと思います。
アメリカに輸出をしていない企業には当面関係はありませんが、企業や製品の品質を評価する指標を設けようというプログラムは、自社の品質レベルを評価したり、品質目標を設定し手継続的な改善を実施したりするうえで参考になるかと思いますので、是非最後までお読みいただければ幸いです。
品質指標報告プログラム(Quality Metrics Reporting Program)に関するパブリックコメント募集
アメリカ食品医薬品局（FDA）は、2022年3月9日に、以前に提案した品質指標報告プログラムの変更に関するコメントの募集を開始しました。
■経緯
FDAは2015年と2016年、品質指標報告プログラム(Quality Metrics Reporting Program)に関するガイダンスのドラフトを発表していましたが、一般的に医薬品製造業者には受け入れられませんでした。
情報収集のコストがかかるだけでなく、そのための膨大な作業負荷にも批判があがり、結局、医薬品製造業者は自発的に品質データを提出することが求められてきました。
そこで、FDAは2022年3月9日に当初の情報収集計画の欠点や、提出された品質データ、医薬品製造業者からのフィードバックをもとに新しいプログラムを検討し、2022年6月7日まで、業界にコメントを募集しました。
■コメント募集内容
Ｉ．背景
Ａ．品質指標
医薬品製造において、品質指標は、製品とプロセスのライフサイクルを測定、評価、監視し、品質リスクを積極的に特定して軽減し、それにより高いレベルの安全性、有効性、配送および性能で運用を管理する客観的な手段である。品質指標は、品質管理システムと工程をモニタし、製造の継続的な改善努力を推進するために、医薬品および生物学的製剤の業界全体で使用されている。製造手順の更新や革新の不履行や、運用上の信頼性 (すなわち、管理状態) の欠如は、公衆衛生に悪影響を与える品質問題につながる可能性があるため、品質指標は重要である。
製造業者の製品が安全で有効で十分な品質であると保証するための最低基準は、現在の規制で要点が説明され、現在のポリシー(医薬品に関する21 CFR 210章及び211章と、ICH Q7原薬GMP(「医薬品の製造管理及び製造管理に関する基準」)で推奨されているCGMPの遵守である。しかし、CGMPの遵守だけでは、必ずしも、製造業者が改善のために投資し、製造性能と品質の一貫した管理状態を維持するために努力しているかどうかを示さない。継続的な改善に重点を置かずにCGMPの持続的な遵守状態を達成することは難しい。
効果的な医薬品品質システム(PQS : Pharmaceutical Quality System)は、継続的なCGMPの遵守とサプライチェインの堅牢性の両方を保証する。品質指標のデータは、製造性能の見識を提供し、製造の業務を改訂し刷新する機会を確認することを可能にするため、効果的なPQSを開発する製造業者に貢献できる。
品質指標は、供給者の選択においても重要な役割を果たし、契約活動と原材料の供給者の監督のための情報を提供し、サプライチェインの混乱を最小化するための適切なモニタリング活動の決定にも役立つ。
組織からの品質指標データはFDAにも役立つ。これらのデータは、FDAが将来の医薬品の不足の予測を改善・緩和し、医薬品製造のための革新的な品質マネジメントシステムを実装するために製薬業界に働きかけるよう、CGMP遵守・査察ポリシーと実務の進展を支援することができる。例えば、品質指標データをFDAのリスクベースの検査スケジューリングに適用し、持続可能なコンプライアンスを示唆する品質指標を持つ組織の定期的な監視査察の頻度/長さを縮小することができる。さらに、品質指標データの提出は、査察の合間の、組織の業務を継続的に洞察することができる。
FDAのリスクベースの規制のアプローチの継続的な導入の一環として、FDAは品質監視活動を裏付ける品質指標報告プログラムの開発および実装することを提案している。このプログラムのもとで、FDAは、以下のことを実施するために、組織により提出された品質指標データを分析することを目指している：
- 組織での製造品質と信頼性のより定量的で客観的な評価基準を得る
- 指標と結果の分析を、FDAの包括的な品質監視プログラムに統合する そして
- 製品の品質問題(例：品質関連の不足や回収)のリスクを特定するのを助けるために分析結果を適用する
Ｂ．品質指標データの提出に関する業界向けのFDAガイダンス
2015年7月、FDAは品質指標の製品ベースの報告のための、義務となる可能性のあるプログラムについて説明した“品質指標の要求”というタイトルのガイダンスのドラフトを発行した。この提案されたプログラムのもとで、製造業者は4つの主要な指標(ロットの合格率(LAR)、製品品質の苦情率(PQCR)、無効化/覆された規格外（OOS）の率 (IOOSR)、および、予定通りの年次の製品照査(APR)または製品品質照査の率)と3つのオプション指標(経営陣の関与、是正処置・予防処置(CAPA)の効果、および工程能力/性能)を提出することになっていた。ガイダンスに関するステイクホルダーのコメントには、複数の組織にまたがる製品レベルでのデータの収集、書式設定、提出に関する負担に関する懸念、提案された指標と定義に関する技術的なコメント、提案された義務的プログラムに関する法的懸念が含まれていた。ステイクホルダーのコメント者は、業界とFDAの両者による学習を可能にするための段階的なアプローチも提案した。
このフィードバックを受けて、FDAは2016年11月に“品質指標データの提出”というタイトルのガイダンスの改訂ドラフトを発表した。2016年のガイダンスは、FDAの提出ポータルサイトを通じて、参加者が製品または組織がデータを報告する、品質指標報告プログラムの最初の自主的な段階が説明していた。FDAは、2015年のガイダンスのドラフトから4つの指標のうちの1つを削除し、残りの3つの主要な指標
(1)製造工程の性能を測定するためのLAR;
(2)実験室の堅牢性を測定するためのIOOSR;
(3)患者または顧客のフィードバックを測定するためのPQCRの提出を要求し、参加のためにインセンティブ
を提案した。このガイダンスでは、FDAが提出されたデータをどのように活用するつもりかについても説明していた。ガイダンスに対するステイクホルダーのコメントは、FDAで標準化した定義は課題のままであり、自発的なプログラムに参加するインセンティブを強化する必要があると示していた。(例：プログラムを開発するためのFDAとの直接の協力は強力なインセンティブの一例だった)。コメント者は、FDAに提出されるデータの価値と有用性と、FDAがプログラムの成功をいかに測定するかをよりよく理解するよう求めた。コメント者達は、広範囲の品質指標プログラムの実装の前に、業界の情報を集めるための試験的なプログラムが好ましいとのべた。
Ｃ．FDAの品質指標の試験的プログラムから学んだ教訓
2018年6月29日に発行された連邦官報の通知で、FDAは、品質部門によって開発・実装され、製品と工程の品質改善をサポートするために使用される品質指標プログラムを持つすべての組織に対して、品質指標サイトへのアクセスプログラムと品質指標のフィードバックプログラムの2つの試験的プログラムが利用可能になったと発表した。
〇品質指標サイトアクセスプログラム
品質指標サイトアクセスプログラムは、FDAスタッフに体験学習の機会を提供し、参加組織に品質指標プログラムの実装と管理に関する利点と課題を説明する機会を提供した。たとえば、参加者は、FDAのガイダンスのドラフトで提案されている指標の定義と、同じ指標に関して業界で一般的に使用される定義の違いを示すために、ケーススタディの形でフィードバックを提供した。彼らはそれらの変更が必要な理由を正当化して、定義の変更を提案した。FDAは、世界中の14の組織の業務を視察し、以下のようなトピックについて組織と対話した：いかに品質指標データが収集・分析・伝達 (例：ダッシュボード、ビジネスインテリジェンスプラットフォーム)され、組織全体で構造化された集中的な方法で報告されるか、いかに経営陣が品質指標データを利用して供給ネットワークのパフォーマンスをモニタするか、いかに経営陣がデータ駆動型の判断をするために指標を活用するか、いかに組織が指標に基づいて継続的な改善を実装しモニタするか、いかにさまざまな品質指標が定義されるか、いかに品質指標データのレビュの結果得られた発見から行動が取られたか、いかに医薬品の不足を積極的に緩和し防止するために取り組みが調整されているか。
〇品質指標フィードバックプログラム
品質指標フィードバックプログラムでは、参加組織がFDAスタッフに品質指標プログラムを発表した。プレゼンテーションに続き、分析的戦略、探索的データ分析、データ準備と構造、コミュニケーションのための視覚化に焦点を当てたディスカッションと知識共有、FDAがいかに高度な分析技術(例：データ/テキストマイニング、インタラクティブな視覚化)、高度な統計手法（例：管理図、時系列分析)、機械学習(例：予測分析、自然言語処理)を使用してデータを分析するために計画しているかについてのデモンストレーションが行われた。これらの議論の中で、FDAは、FDAの改訂したガイダンスのドラフトに記載されているアプローチを適用する際に予想される業界の課題に関するフィードバックも得た。
参加者は、FDA提出ポータルサイトを通じて品質指標データを提出し、ユーザーエクスペリエンスに関するフィードバックを提供する機会を得た。業界の参加者は、新薬、ジェネリック医薬品、非処方薬(店頭(OTC)として知られる)、生物学的製品など、製薬業界のさまざまな分野を代表していた。
データ分析に焦点を当てた2つの試験的プログラムにおける業界との専門会議は、品質指標報告プログラムの方向性を決める、FDAのための以下の重要な教訓をもたらした。
- 異なる業種は、個々の事業やビジネス動態のニーズにより、異なる指標を好む。従って、指標を選択する際に、十分な柔軟性を持つプログラムを実装する必要がある。重要な業務のエリア(例：製造工程の性能)を特定し、組織がいくつかのオプションから適切な指標を選択することを可能にすることが、より実現可能なアプローチである。
- 報告すべきものとして選ばれた指標は、測定対象の業務領域にとって意味があり、指標として収集されたデータは、工程の改善や設備投資の意思決定に影響を与えるものであるべきである。
- 場合によっては、特定の業務領域を評価するのに、1つの指標より指標の組み合わせのほうが好まれる。
- 参加者の過半数は、組織レベルでデータを報告し、製品により分割する可能性を持つことを好むが、一部の参加者はビジネス構造(例：垂直的に統合された企業)により、製品レベルの報告を好む。
- 2016年に改訂されたガイダンスの定義に基づき、LARとPQCRの計算は、100％を超えるレートや無効な計算(例：0での割り算)のような数学的不具合が発生する可能性がある。これらの不具合は、リアルタイムの作業による固有の変動や、特定の期間でいかに分母を定義するかにより引き起こされる。
- LARやIOOSRは組織により定期的にモニタされる品質指標だが、それらは、時間に伴う変動が限られていたり範囲が限られているため、組織が指標を特定できず、存在しない性能問題にハイライトをあてることで、誤検知につながる可能性がある。他の指標が、製造工程の性能や試験の堅牢性の代わりとして特定されるべきである。これに限定されないが、例えば、Right-First-Time Rate、工程能力、リードタイムの遵守などがある。
- 品質システムの有効性は、PQSに関するデータを収集する多数の組織により証明されている通り、品質指標報告プログラムの重要な要素である。例えば、CAPAプログラムの有効性、繰り返しの逸脱、保守プログラム、適時性に関する指標が含まれる。
- クオリティカルチャに関する指標は性能と信頼性の重要な指標だが、他の指標と異なり、数値の指標のみに基づいて、組織でクオリティカルチャをとらえることは難しい。数値のKPI(主要業績評価指数)(例：APRの適時性や惜しい失敗)と、定性的なサマリ(例：経営陣のコミットメントや品質計画)の両方は、クオリティカルチャの更なる理解のために使用することができる。
- 品質指標フィードバックプログラム中に提出されたデータのFDAによる分析は、統計的な品質管理アプリケーション(例：統計的な工程管理や工程能力)と、機械学習/自然言語処理の使用は、組織により提出された品質指標データを評価するために適切で意味のある分析戦略である。
ＩＩ．FDA品質指標報告プログラムの提案された方向性
FDAは、試験的プログラムや、ステイクホルダーのフィードバックから学んだ教訓を、2016年改訂ドラフトガイダンスで提示された品質指標報告プログラムの改善のために適用した。この章では、プログラムの潜在的な方向性を要約し、III章では、このアプローチの具体的な側面への意見の提供を求める。
FDAは、品質指標データの収集と提出を担当する組織の変更は必要ないと考えている。2016年改訂ドラフトガイダンスで定義されている“対象組織”とは、“対象医薬品”(FD&C Act 505またはPublic Health Service Act 351のもとで承認申請対象の製品、FD&C Act 505Gに従って合法的に販売されている製品(承認された医薬品の申請なしで市販されている非処方薬);未承認の最終製品として販売されている製品；対象医薬品の製造に使用される医薬品有効成分である。“対象組織”には、契約試験機関、契約滅菌業者、および契約包装業者が含まれる。
FDAは、品質指標プログラムの他の側面の変更を検討している。ステイクホルダーは、異なる業種は、異なる品質指標を好む可能性を示していた。製造業者に柔軟性を提供するため、FDAは、品質指標や定義の標準化に焦点を当てないつもりである。代りに、FDAは、持続可能な製品品質と可用性を保証するために重要な業務領域を特定し、製造業者が各業務領域から意味のある指標を選択し、継続的な改善の機会を確認できるようにするつもりである。指標の定義では、組織が特定の指標を計算する方法を指定しないつもりである。むしろ、報告をする組織は、それぞれの業務領域から最も適切な指標を選択し、それがどのように計算されたかをFDAに通知することになるだろう。試験的参加者から集められたフィードバックを通してFDAは現時点で品質指標報告プログラムのために適切な以下の４つの一般的業務領域を特定した；
(1)製造工程性能
(2)PQSの効果
(3)試験室のパフォーマンス
(4)サプライチェインの堅牢性
各業務に関連した品質指標の例は以下の通りである：
１．製造工程性能
・工程能力/性能指数(Cpk/Ppk)：
工程の出来高を規格の限界と比較し、比率として計算される尺度(例：Ppkが1.33を超える属性の
総数をPpkが使用されている属性の総数で割った値)。妥当なサンプル数を使った標準偏差の測定
を検討することが重要である。
・LAR：
特定の期間に合格になったロットの割合の測定。LARの計算に使用される情報の例は、完成された
ロット、処理されたロット、未完のロット、不合格になったロット、リリースされたロット、
承認されたロット、中止されたロット、並行/予備のロットを含む。
・Right-First-Time Rate:
不適合の発生がなく製造されたロットの割合の測定。Right-First-Time Rateの計算に使用
される情報の例は、逸脱の数、処理されたロット、未完のロット、不適合の数、初回で合格に
なったロットを含む。
・ロット・リリース・サイクル・タイム：
ロットの処理のプロセスにかかる時間の測定。ロット・リリース・サイクル・タイムは、時間
や日数などの適切な測定単位により計算される。
２．PQSの効果
・CAPAの効果：
実施され、効果的であるとみなされたCAPA計画の割合の測定(すなわち、有効である として完了
した有効性の検証)。CAPAの有効性を計算するために使用される情報の例は、開始されたCAPAの
数、予定通りに完了したCAPA、“有効”として完了したCAPA、期日を過ぎたCAPA、結果として
再教育となったCAPAを含む。
・繰り返しの逸脱率：
逸脱の再発生の測定の割合の尺度。繰り返しの逸脱率の計算に使用される情報の例は、逸脱の
総数と、同じ根本原因とされる逸脱の数を含む。
・変更管理の有効性：
GMP施設、システム、装置、工程に対して実施された変更の適時性と有効性の測定。
この指標を計算するために使用される情報の例は、変更の予定通りの完了、有効性のチェックが
遅れた総数、
開始された変更の総数、事後と事前に開始された変更の数、有効とみなされた変更の総数を含む。
・全体的な装置の有効性：
計画された製造時間を使った生産性の測定。全体的な装置の有効性は、可用性(例：計画された
製造時間、作業時間)、性能(例：生産能力)、品質(合格にならなかった出来高)に関する情報を
使用して計算されることができる。
・計画外メンテナンス：
計画、もしくは、スケジュールされていなかったメンテナンス時間の割合の測定。この指標を
計算するために使用される情報の例は、合計メンテナンス時間と計画されたメンテナンス時間を
含む。
３．試験室のパフォーマンス
・リードタイムの遵守：
スケジュールの要求に従って予定通りに完了された試験室の試験の割合の測定。
リードタイムの遵守は、例えば、リリース及び安定性試験の開始と回転時間のトラッキング
(すなわち、品質管理(QC)の開始と完了の日数)、データレビュと文書化のトラッキング、バッチ
の処理前の最終結果報告のトラッキング、目標日に対するQC試験完了日の比較により計算される。
・Right-First-Time Rate：
逸脱の発生なしに実施された試験の割合の測定。試験室のパフォーマンスの指標としての
Right-First-Time Rateは、例えば、無効化した分析の割合、人的的ミスのために無効化された
分析の数、レビュ中のCGMP文書のエラーのトラッキングにより計算することができる。
・IOOSR：
正確に試験を実施するための試験室の能力を示す尺度。この指標を計算するために使用される情報の
例は、実施された試験の総数と、測定プロセスの異常により無効化されたOOSの総数で計算できる。
・キャリブレーションの適時性：
計画通りに意図された目的のための、試験室の機器を検査、校正、試験の遵守の測定。この指標は、
キャリブレーションの基準とスケジュールで測定することができる。
４．サプライチェインの堅牢性
・オンタイム・インフル(OTIF)：
正しい数量で、注文で指定されたスケジュールに従って、貨物が目的地に出荷される程度の測定。
この指標は、出荷された注文数、期限を過ぎた注文の数、許容範囲内で出荷された注文数のような
情報を使って計算されることができる。
・フィル・レート：
指定された期間内の、総需要に対して出荷された注文数を定量化した測定。この指標を計算する
ために使用することのできる情報の例は、出荷された注文の数、発注された注文の数、受領した
注文の数を含む。
・時間通りの処理：
時間通りに処理が行われたロットの割合の測定。この指標を計算するために使用される情報の例は、
処理されたロットの総数と、時間通りに処理されたロットの総数で計算されることができる。
・手持ち在庫の日数：
使用可能な平均在庫量を会社がいかに利用するかの尺度。在庫として残っている日数である。
試験的プログラムの参加者の過半数が組織レベルでデータを報告することを好むことを前提として、
FDAは、製造の流れ、製品のタイプ、製品のレベル(例：申請数や製品群)により分けるオプション
も備えた、組織レベルの品質指標データの集計と報告のためのアプローチを検討している。
データが提供されたら、FDAは査察のリソースの割り当てに役立つ見識を提供するために、統計的および機械学習的方法を使って情報を分析する予定である。例として、製品の傾向と集団の試験、識別のための探索的および時系列分析、それによる経時的な組織の健全性のモニタリング、組織の全体的なPQSの効果を判断するのを助けるために機械学習モデルへの入力としての品質指標データの利用が含まれる。
ＩＩＩ．コメントのお願い
我々は、品質指標報告プログラムに関するFDAの提案した方向性の以下の側面についてコメントを求めている。この章で提起された質問は網羅的なものではない。また我々は、ステイクホルダーやその他の関係者がFDAの品質指標報告プログラムで提供したいその他の関連情報にも関心がある。
FDAはステイクホルダーが、利用可能な例や補足情報などコメントの根拠を提供することを奨励している。
Ａ．報告レベル
１．報告は組織レベルで集計されるべきであると思うか？
２．組織レベルでの報告は受託製造組織による品質指標データの提出を容易にするか？
３．組織において、通常、製品群で指標を評価する場合、貴社の業界の“製品群”の便利な定義は何か？
Ｂ．業務領域と品質指標
１．この通知のＩＩ章にあげられた一般的な業務領域がFDAの品質指標報告プログラムの目的に合わな
いと思う場合、FDAは他にどの業務領域を考慮すべきか？
２．FDAがクオリティカルチャを一般的な業務領域の一つとみなす場合、堅牢なクオリティカルチャの
重要な要素は何か？また、これらの要素は定量的に測定可能か？もしそうであれば、クオリティカ
ルチャの情報を定量的指標(惜しい失敗、オンタイムのAPR、クオリティカルチャの二値応答または
その他の数値的指標/KPI)として獲得することをどのように推奨するか？
３．FDAが提案する品質指標の例は、指定された業務領域にとって適切な指標でないと思うか？
４．指定された業務領域にとって、FDAは他に何の指標を考慮すべきか？
５．FDAは、工程の能力と性能の指標を組み込んでいる組織の経験に関心がある。例えば、品質指標
プログラム(例：特定の製品のCpkおよび/またはPpkの報告、組織レベルでの集計)の一環として、
FDAにCpkおよび/またはPpkをどのように報告するつもりか？
６．PQSの有効性をよりよくモニタし、適切なビジネス戦略を通知し、洞察に満ちた傾向をとらえ、
継続的な改善行動を推進するために、指標は、組織によって変更されたり調整されたりする必要が
あるかもしれない。品質指標の変更または修正を正当化するために、(組織またはFDAによって)どの
ような基準が適用されるべきか？どれくらい頻繁に変更や修正が必要とされると思うか？
７．特定の業務領域を評価する際、指標として、複数の指標に対して1つの指標を信用しますか(例：
1つの指標が他の指標に影響を与えるので、2つの指標が一緒に考慮される)？指標のどの組み合わせ
は意味があり有用だったか？
Ｃ．その他の検討事項
１．品質指標報告プログラムにおいて対処すべき特定の製品カテゴリ(例：ジェネリック医薬品、
OTC医薬品、生物学的製剤)に固有の検討事項はあるか？
２．品質指標データの提出について、最適な報告頻度(例：毎月、四半期、毎年、または四半期や
月ごとにセグメント化)は何か？
３．製造業者がアメリカと外国のデータを含み、自国のデータを抽出してFDAに提出できない場合、
これらのデータをどのようにFDAに有益な方法で提出できるか？
４．FDAがプログラムについて提案した方向性について、今後FDAが方針文書で対処しなければいけ
ない側面はあるか？
出典：
https://www.gmp-publishing.com/content/en/gmp-news/news-about-gmp-cgmp/d/fda-asks-for-feedback-on-streamlined-quality-metrics-program
https://www.fda.gov/drugs/pharmaceutical-quality-resources/quality-metrics-drug-manufacturing
https://www.federalregister.gov/documents/2022/03/09/2022-04972/food-and-drug-administration-quality-metrics-reporting-program-establishment-of-a-public-docket
～～～～～～～～～～～～～～～～～～～～～～～～～～～～～～～～～～～～～～～～
まとめ
いかがでしたでしょうか。
品質指標の考え方は、自社や委託先の品質レベルの把握や、目標設定の参考になると思います。
品質指標を①製造工程性能②PQSの効果③試験室のパフォーマンス④サプライチェインの堅牢性
の4分野に分けてとらえる考え方や、指標の例（LAR、Right-First-Time Rate、、ロット・リリース・
サイクル・タイム、オンタイム・インフル、フィル・レート等）は利用できそうです。
FDAが組織のクオリティカルチャの指標化を検討している点も興味深かったです。
FDAが品質指標を査察のリソースの割り当てに利用しようと考えていることから、今後このプログラム
は企業にとって重要なものになっていくと思われます。
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Four of these are formally managed as local historic districts by the town.
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Remember, the Page of Swords is a reminder to balance intellect with intuition, logic with spirituality, and curiosity with groundedness.
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Which state will not be too sizzling or too cold?
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