PQの目的

PQの目的

PQ(Performance Qualification)は長期にわたるプロセスの安定性の確立のために実施する。つまり、プロセスが恒常的に規格に合格した製品を通常の操作条件において生産できることがPQでの目的である。
日本語では、性能適格性評価と呼ばれる。
ここで性能という言葉を勘違いしてはならない。性能はスピードや処理能力を指すのではない。
性能は、”直進性能”と理解すれば分かりやすい。10ロット目も、100ロット目も、1,000ロット目も全て同一の仕様・品質で製造できることが直進性のあるプロセスである。
そのため、かつてはFDAは少なくとも3ロットでPQを実施することを要求した。
その理由は2ロットであれば必ず直性が引けるのであるが、3ロット以上になると結果が直線状に並んでいるか否かが分かるためである。

PIC/S GMP Annex 15のPQ定義は下記の通りである。

性能適格性評価(PQ)
施設、システム、装置を組み立てた際に、承認された製法や製品規格に基づいて、それらが効果的に再現性よく稼働することを検証し、文書化すること。


PQは以下の事項に配慮して実施する。

  • OQで確立した実際の製品とプロセスパラメータ並びに手法
  • 製品規格の許容性
  • OQで確立した工程能力の保証
  • プロセスの再現(繰り返し)性、長期のプロセス安定性

PQでは、OQで確立した実生産の条件で製品を製造する。同時に様々なアクションレベル、それを含んだ標準操作手順書(SOP)の内容を確認し、チャレンジテストの繰り返しでよりプロセスの保証を高める。

製品やプロセスのデータは、プロセスのアウトプットが規格内である通常の変動範囲が決まるように解析されるべきである。

通常の変動範囲を知ることで、コントロールされた状態か特定のアウトプットを製造できるのに一定の許容範囲にあるかが明確になる。これにより変動幅を軽減し管理すると高度な品質保証になる。
プロセスの特性や繊細さに依存するが、管理する変動要因は以下の通りである。

  • 温度/湿度/機器の外装・結露
  • 電力供給上の変動/振動/光
  • 環境汚染/プロセス水の純度/人的要因
  • 原料の銘柄違い
  • 原料ロット切り替わりによる原液粘度変動(製品の除去率性能に影響)

PIC/S GMP Annex 15では、PQは、OQまたはプロセスバリデーションと同時に実施することが可能としている。
そのため、現在では、PQを単独で実施することはほとんどなくなった。

関連商品

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