Computerized System(コンピュータ化システム)とは

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Computerized System Validationについて研究するページです。

*万が一文中に解釈の間違い等がありましても、当社では責任をとりかねます。
 本文書の改訂は予告なく行われることがあります。

PIC/S GMPの付属資料であるAnnex 11 Computerised Systems(2013年1月1日改定)には、以下のように記されている。

Where a computerised system replaces a manual operation, there should be no resultant decrease in product quality, process control or quality assurance. There should be no increase in the overall risk of the process.
(マニュアルベースの作業をコンピュータ化システムに置き換える場合、結果として製品の品質、プロセスコントロールつまり品質保証を劣化させてはならない。プロセスの全般的なリスクが増えてもいけない。)

つまり、手作業で実施してきた医薬品等の製造等をコンピュータ化した際に、製造される医薬品の品質や品質保証を劣化させてはいけないということである。
ここで、初心者には聞きなれない言葉として「コンピュータ化システム」というものがある。
例えてみれば、炊飯器があげられる。

昔は、釜を使用し、手作業で火力を調節しながら米を炊いていた。「はじめちょろちょろなかぱっぱっ 赤子泣いても蓋とるな」といった具合である。
その後、火力がガスや電気になり、現在では、マイコンがそれら火力を制御するようになった。
マイコン(ソフトウェア、ファームウェア)で制御しているシステムを“コンピュータ化システム”と呼ぶ。
ここで大切なことは、釜(手作業)で炊いたご飯とマイコン炊飯器で炊いたご飯が同じくらい美味しいことである。
今でも、釜で炊いたご飯の方が美味しいと感じることが多い。いわゆる匠の味である。
製薬業における製造工程でも、同様にコンピュータで制御することが多くなった。
例えば、打錠機、造粒機、滅菌機、乾燥機などの構造設備(ハード)がその例である。
GMPでは、基本事項としてハードとソフトの両面を保証することによって、その目的を達成することになる。
構造設備等のハードには、マイコンと呼ばれるICチップが搭載されており、その中にはファームウェアと呼ばれるプログラムが焼き付けられている。または、PLC(Programable Logical Controller)と呼ばれる、各社毎に設定を変更できる仕組みが搭載されていることもある。
このように構造設備等のハードは、大きなハードウェア(H/W)に対して、比較的小さなプログラムつまりソフトウェア(S/W)が搭載され、制御していることが多い。
上記のようにハードは、H/WとS/Wにより構成される。
プロセスバリデーションの原則として、ハードは事前にその適確性を検証しておかなければならない。
その際に、当該ハードがマニュアル(手作業)ではなく、S/Wで制御される場合には、当然のことながら、当該S/Wは十分な検証が必要となる。つまり、これがCSVである。
逆の言い方をすれば、S/Wが搭載されていなければ、CSVは実施しない。(というよりも実施できない。)

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