自宅で食べる刺身はなぜ美味しくないのか？

自宅で食べる刺身はなぜ美味しくないのか？

読者は、寿司屋などで食べる刺身に比べて、自宅で夕食に食べる刺身が美味しくないと感じたことはないだろうか。

マグロなどの鮮魚は、漁師が釣り上げてから鮮魚店に並ぶまで、その品質を確保するために、コールドチェーン（冷温管理）が厳重に守られているのである。

しかしながら、買い物した後、炎天下にも関わらず袋にそのまま入れて、自宅まで持ち帰っているケースがほとんどである。

この際に、コールドチェーンが切れてしまっているのである。 本来ならば、袋の中に氷を入れてコールドチェーンが切れないように、素早く持ち帰る必要があるのである。

医薬品の供給においても同じことが言える。GDPガイドラインが策定された通り、医薬品は製造したままの品質で患者まで届けることが重要である。

仕事柄、筆者は多くの医薬品製造所の監査を実施する。その際に出荷するトラックヤードを確認する。

もうすぐトラックが到着すると予想される時刻の直前に、製品をトラックヤードに出して並べているケースが見受けられる。

もちろん、多くの企業のSOPでは、短時間の一過的逸脱（Excursion）は、認められていることが多い。

しかしである。毎日、必ずトラックが同じ時刻に到着するとは限らない。渋滞や事故もあり得るのである。

果たして、この間のリードタイムを測定しているだろうか。例え室温管理の医薬品であっても、30℃を超えることは好ましくない。場合によっては、長時間炎天下にさらされ、コールドチェーンが切れてしまっている可能性もある。

また、ある治験において、真夏にもかかわらず、治験薬を配送する際にデータロガーを入れていなかったケースがあった。もちろん治験薬は専用トラックによって配送されていたため、おそらく温度逸脱はしていなかっただろうとは推察された。しかしながら、データロガーが入れられていなかったため、温度逸脱を起こしていない証拠が得られなかったのである。

証拠がなければ、逸脱していないことの証明は出来ない。 このように、製造所内ではルールを決め、厳密に品質が管理されていたとしても、製造所の外の世界まで配慮できていないケースが散見されるので、注意が必要である。

関連商品

[blogcard url=https://xn--2lwu4a.jp/qms-rx/ title=”QMS（手順書）ひな形　医薬品関連” ]

[blogcard url= https://ecompliance.co.jp/SHOP/EL-075.html title=”【セミナービデオ】医薬品の適正流通（GDP）ガイドラインの管理体制と文書管理”]

[blogcard url= https://ecompliance.co.jp/SHOP/P133.html title=”【書籍】 ―最新版― 【 医薬品包装/容器 】 3極局方の包装材料試験/品質基準と材料要求特性”]

[blogcard url= https://ecompliance.co.jp/SHOP/EL-006.html title=”【セミナービデオ】データインテグリティSOP作成セミナー”]

[blogcard url= https://ecompliance.co.jp/SHOP/QMS-MHLW-09.html title=”【2021年度改正QMS省令対応】内部監査規程・手順書・様式”]

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