何謂校正(calibration)與確效(validation)?
為了維持純水、超純水的水質,我們已經為各位介紹如何對系統進行管理的方法與重要性。而對於一些必須進一步進行高度管理的用水(食品、醫化學試劑、化妝品等產品,與臨床上所使用的純水與超純水),還必須配合法律的規範。
例如,藥品的生產製造就必須符合 cGMP(Good Manufacturing Practice)的規範。cGMP規範,是為了提供能夠被消費者安心使用,具優良品質的藥品、醫療用具等產品,生產者於製造過程中所應進行的管理,與所應遵守事項的相關規定。而所謂確效,其定義為「為了符合產品預期,應該對生產場所的結構、設備、生產程序及工程,及其它與生產以及品質管理的方法都加以檢驗,並予以文件化的記錄」。確效的最重要功能,是事先訂定符合相關必要條件的基準值,也就是把「基準明確化」,並對系統的實際運作情形進行日常管理,並核對二者。也就是「將結果與基準相比對」,使整個生產製造符合所設定的基準值的一個手段。
對於超純水系統,其純化所得的超純水,若含有污染物質並對生產或實驗結果產生重大影響時,使用者在日常操作中就必須嚴格遵守系統的運作管理,以確保純化水的水質符合要求。為了實現此一精神,使用者只要先訂定符合使用用途的水質標準,並依照執行程序來進行確效性確認,如此就可以達到目的。
總而言之,存在於自然界,我們日常所接觸的水,不只是 “H2O”,而是含有各種物質的水溶液。

但是,如果檢測儀器無法正確檢測,即使執行確效的驗證程序也沒有意義。所以,同時應以標準器材與標準樣品對所使用的檢測儀器進行「校正」(calibration)動作,使其檢測誤差範圍落在標準之內。而為了讓所使用的標準器材能夠具有正確的數值,應進一步以高精密度的檢測儀器進行管理。像這樣,「每次以更高位階的檢測基準來校正檢測儀器,確立符合國家標準、國際標準」就稱為「追溯性 」(traceability) 。校正用的檢測儀器經追溯來確保其正確性是必要的,而 ISO9001 與 9004 對國際檢測儀器有詳細的管理規定。雖然包括 cGMP 在內的各項相關法律並不受到 ISO 的約束,但一定要透過某種方法來進行可信度的確認。
根據前述的方式,就可以進行超純水系統的確效作業。而超純水系統的製造廠商也可以據此提出執行確效作業的相關技術支援。
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