出荷判定のあり方について

出荷判定のあり方について

GMP省令およびQMS 省令においては、製品を市場に出荷する際、出荷判定を実施しなければならない。
出荷判定においては、製造の記録および品質試験の記録を、品質保証部門がチェックをした上で出荷を許可することになっている。
しかしである。日本の企業において、多くの場合、製造記録や品質試験記録に不備がなければ、そのまま出荷の捺印（またはサイン）をしている。
そのような単純な方法では、パート職員やアルバイトでも可能である。

本来、出荷判定は品質保証部門のような第三者が、再度製造の記録や品質試験の記録を徹底的に調査し、疑義が全くない場合に出荷を承認することになるのである。
筆者は仕事柄、海外の企業にも監査に赴くことがある。
欧州においてはQualified Person（QP：欧州以外のPIC/S加盟国においては、Authorised Person）のみが出荷を承認することができる。
たとえ経営者や工場長であっても、QPの資格を持たない者は出荷を承認することはできない。

欧州の製薬企業では、多くの場合、QPが配下を4～5名使って、あらゆる製造記録や品質記録を徹底的に調査させるさせている。
しかもダブルチェックを行わせているのである。
製造記録には、バリデーションの記録なども含まれる。品質試験の記録には、サンプリングの記録なども含まれる。
当然、転記ミスや記載ミス、計算ミスなどもチェックされる。
特に生データの変更の記録については、厳重にチェックしなければならない。
電子記録の場合、監査証跡の確認が重要である。
その他、必要に応じて試薬の管理状況、校正の記録、教育訓練の記録などを参照することもある。
最終的にQPが当該製品の品質に確信を持てた段階で、出荷を承認するのである。

2013年1月1日に発行された「PIC/S GMP Annex 11 Computerised Systems」には下記のような記載がある。
15．Batch release（バッチリリース）
コンピュータ化システムが、承認およびバッチリリースの記録に使用される場合には、そのシステムは適格者（Authorised Person）にのみバッチのリリースの承認を許可し、バッチをリリースした者すなわち承認した者を明確に記録しなければならない。
当該作業には、電子署名を利用しなければならない。
出荷承認したQP（AP）の氏名は、バッチ毎に明確に記録しておかなければならない。
一旦QP（AP）が出荷を承認すれば、例え製造部門や品質部門にミスがあった場合であっても、出荷判定者がその責を負うことになる。
ここにおいて、電子署名を利用しなければならない理由は、電子署名はバックデートできないためである。（手書きの署名は、任意の日付を記載することが可能であるため）
さらにAnnex 11には下記の要求事項がある。
８．Printouts（印刷物）
8.1　電子的に保管されたデータについては、明確に印刷されたコピーを出力できなければならない。
8.2　バッチリリースを裏付ける記録に対しては、データが原本の入力時から変更されているかどうかを示す印刷物を生成できなければならない。
電子的に保管されたデータとは、生データだけではなく、監査証跡等のメタデータも含まれる。
バッチリリース（出荷） を裏付ける記録（つまり製造記録および品質試験記録）は、最初の入力以降、変更されているかどうかを確認できるようになっていなければならない。
つまり監査証跡が印刷できなければならないのである。
品質保証部門や監査担当者や当局の査察官等は、監査証跡をチェックする必要があるためである。
つまり、改ざんを発見する仕組みが必要なのである。
 1997年8月に施行された、21 CFR Part 11 Electronic Records, Electronic Singatureには、下記の記載がある。
11.10（h）
適宜、データ入力や操作の指示の根拠となっている事項の有効性を判定するために（端末装置などの）装置チェックを利用すること。
この要求事項は意味が分かりにくく曖昧であり、正しく理解している者は少ない。
この要求事項は、出荷判定などの際に、正しい端末（すなわち正しい者）から入力されており、許可されていない者が出荷判定をすることがないようにとの要求なのである。
筆者は、かつて長年出荷判定を担当してきた元製薬企業の品質保証部長と話す機会があった。
彼は定年退職した際に、やっと安心して眠れるようになったと言う。
なぜならば自身が出荷を承認した製品の品質に何らかの問題があり、患者に健康被害を及ぼした場合、責任を感じるためである。

多くの製薬企業および医療機器企業は、出荷判定の目的を良く理解し、患者目線で徹底した記録のチェックを行ったうえで出荷されることを望む。

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