ISO-9001:2000以降は、経営者の責任が重要視されている。これは、製薬・医療機器企業に関わらず、当局の査察にかけるリソースに限界があることに基づいている。
査察官がわずかな日数で発見できるエラーを修正しただけでは、氷山の一角にすぎないのである。
したがって、当局が査察するのではなく、経営者自らが品質システム(QS)を構築し、品質マニュアルを作成することを求めている。
つまり経営者のコミットメントを求めているのである。
経営者が作成した品質マニュアルは、組織の隅々まで周知を図らなければならない。
これを内部統制(Corporate Governance)と呼ぶ。
規制当局の査察官は、この品質システムが確立されており、適切に履行されているかどうかを査察するのである。
これをシステム査察と呼ぶ。
それでは、どのような企業がFDA等の査察官に安心感を与えるのであろうか。
- 品質システムが有効に機能しており、その証拠が揃っている。
- 優秀な(スキル・洞察力をもった)監査員が存在し、内部監査(Self Inspection)が適切に実施されており、品質システムが有効であることを常に確認している。
- 万が一、内部監査で問題が発覚すれば、改善指示を出しており、CAPAが実行され、常に改善を図っている。
- FDA査察官の質問に自信(根拠)をもって回答し、適切な資料で説明ができる。
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