■製薬会社の「要注意工場」、国と自治体が抜き打ち検査へ 監視体制を強化 [健康ダイジェスト]
後発薬メーカーなどによる相次ぐ品質不正問題を受け、厚生労働省は、製薬会社の製造拠点のうち、品質管理に問題を抱えている可能性が高い「要注意工場」を選び出し、重点的な検査に乗り出します。2023年度中に導入する方針で、国と都道府県が連携して抜き打ちで実施します。従来の検査では長年にわたり品質不正を見逃していたケースがあったため、監視体制を強化します。
厚労省によると、要注意工場は、製造する医薬品の品目数の多さ、製造工程の複雑さ、過去の調査で問題が見付かったことがあるか、品質管理に懸念を生じさせる情報の有無、などから抽出します。特殊な製造技術の使用、生産能力と比べ従業員数が少ない、不正が発覚した場合の影響の大きさなども考慮します。
あらかじめ重点的に調べる項目を整理し、検査の実効性を高めます。要注意工場としてどこに検査に入ったかは公表しません。
製薬会社の工場は今年７月時点で、国内に133カ所あり、都道府県や国は医薬品医療機器法（薬機法）に基づき、１～３年ごとに、定期的な立ち入り検査を実施しています。製薬会社へ事前に通告しない抜き打ち検査も行っています。
しかし、後発薬メーカーなどでは2020年以降、不祥事が相次ぎ、業務停止などで薬の供給不足を招くとともに、製造現場のずさんな実態が明らかになっています。
長年にわたり発覚を免れる悪質なケースも起きています。爪水虫などの治療薬に睡眠導入剤が混入していた小林化工（福井県あわら市）では、虚偽の製造記録を記した帳簿（二重帳簿）を作成していたため、福井県は不正を見抜けませんでした。
今年10月には、沢井製薬（大阪市淀川区）の九州工場（福岡県飯塚市）で８年前から、品質試験を不正な手順で行い、国の基準をクリアしたように見せ掛けていたことが発覚しました。製薬会社の品質管理に対する意識の低さが問題視されています。
厚労省の担当者は、「現在の検査体制では十分に対応できていない。巧妙な違反行為にも対応できるようにしたい」としています。
２０２３年１２月１０日（日）
厚労省によると、要注意工場は、製造する医薬品の品目数の多さ、製造工程の複雑さ、過去の調査で問題が見付かったことがあるか、品質管理に懸念を生じさせる情報の有無、などから抽出します。特殊な製造技術の使用、生産能力と比べ従業員数が少ない、不正が発覚した場合の影響の大きさなども考慮します。
あらかじめ重点的に調べる項目を整理し、検査の実効性を高めます。要注意工場としてどこに検査に入ったかは公表しません。
製薬会社の工場は今年７月時点で、国内に133カ所あり、都道府県や国は医薬品医療機器法（薬機法）に基づき、１～３年ごとに、定期的な立ち入り検査を実施しています。製薬会社へ事前に通告しない抜き打ち検査も行っています。
しかし、後発薬メーカーなどでは2020年以降、不祥事が相次ぎ、業務停止などで薬の供給不足を招くとともに、製造現場のずさんな実態が明らかになっています。
長年にわたり発覚を免れる悪質なケースも起きています。爪水虫などの治療薬に睡眠導入剤が混入していた小林化工（福井県あわら市）では、虚偽の製造記録を記した帳簿（二重帳簿）を作成していたため、福井県は不正を見抜けませんでした。
今年10月には、沢井製薬（大阪市淀川区）の九州工場（福岡県飯塚市）で８年前から、品質試験を不正な手順で行い、国の基準をクリアしたように見せ掛けていたことが発覚しました。製薬会社の品質管理に対する意識の低さが問題視されています。
厚労省の担当者は、「現在の検査体制では十分に対応できていない。巧妙な違反行為にも対応できるようにしたい」としています。
２０２３年１２月１０日（日）
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‘I didn’t know what to say’: Wiegman praises England despite Olympic blow
Manager ‘proud’ but 6-0 win over Scotland was not enough
‘We really thought we got it, and then we didn’t make it’
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Sarina Wiegman said she “didn’t know what to say” to England’s heartbroken stars as they stood in a huddle on hearing the news that the Netherlands had scored a fourth against Belgium to knock them out of the Nations League on goal difference and end any chance of qualifying for the Olympic Games next year.
England looked to have done enough when Lucy Bronze’s late header capped a 6-0 victory against Scotland after 90 minutes of playing leapfrog with the Netherlands at the top of League A Group 1. But Damaris Egurrola’s 95th-minute goal for the Dutch earned them a 4-0 win minutes after England’s game had ended.
Alex Greenwood and Lucy Bronze console one another after hearing the news from the Netherlands.
England thrash Scotland but cannot avoid Team GB Olympic heartbreak
Read more
After the third Dutch goal in the 91st minute Wiegman, who had been relaying news of the score to the team via Bronze, who was nearest the dugout at right-back, urged them to go on the hunt.
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“I said: ‘We have to score now,’” she said. “We were pushing to score that goal anyway, because things can change any minute. So, then they scored, and we said now we have to go, we couldn’t play any scenario because there was no time, it was the end of the game, so she just ran forward, got the goal, that was really good, and I thought now we’re going to get it, but … it was not enough.”
England grouped in a circle, as hopes of Olympic qualification for Team GB died with England’s exit from the Nations League. Only the top two European sides and France as hosts will be at Paris 2024.
“We were waiting for some long minutes, and we really thought we got it, and then we didn’t make it,” the manager said. “I said I didn’t know what to say. All I could say was I’m really proud of our performance and what we did this whole week. But it’s not enough and it’s really, really disappointing.”
On whether there was a small silver lining in England’s players getting a summer off and some much-needed rest in an increasingly packed calendar, Wiegman said: “Well, you want to go to every major tournament. The career of a football player is only a certain amount of time, so if you can play every major tournament of course every player wants that. In the bigger picture, we have to look at the calendar.
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‘I didn’t know what to say’: Wiegman praises England despite Olympic blow
Manager ‘proud’ but 6-0 win over Scotland was not enough
‘We really thought we got it, and then we didn’t make it’
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Sarina Wiegman said she “didn’t know what to say” to England’s heartbroken stars as they stood in a huddle on hearing the news that the Netherlands had scored a fourth against Belgium to knock them out of the Nations League on goal difference and end any chance of qualifying for the Olympic Games next year.
England looked to have done enough when Lucy Bronze’s late header capped a 6-0 victory against Scotland after 90 minutes of playing leapfrog with the Netherlands at the top of League A Group 1. But Damaris Egurrola’s 95th-minute goal for the Dutch earned them a 4-0 win minutes after England’s game had ended.
Alex Greenwood and Lucy Bronze console one another after hearing the news from the Netherlands.
England thrash Scotland but cannot avoid Team GB Olympic heartbreak
Read more
After the third Dutch goal in the 91st minute Wiegman, who had been relaying news of the score to the team via Bronze, who was nearest the dugout at right-back, urged them to go on the hunt.
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“I said: ‘We have to score now,’” she said. “We were pushing to score that goal anyway, because things can change any minute. So, then they scored, and we said now we have to go, we couldn’t play any scenario because there was no time, it was the end of the game, so she just ran forward, got the goal, that was really good, and I thought now we’re going to get it, but … it was not enough.”
England grouped in a circle, as hopes of Olympic qualification for Team GB died with England’s exit from the Nations League. Only the top two European sides and France as hosts will be at Paris 2024.
“We were waiting for some long minutes, and we really thought we got it, and then we didn’t make it,” the manager said. “I said I didn’t know what to say. All I could say was I’m really proud of our performance and what we did this whole week. But it’s not enough and it’s really, really disappointing.”
On whether there was a small silver lining in England’s players getting a summer off and some much-needed rest in an increasingly packed calendar, Wiegman said: “Well, you want to go to every major tournament. The career of a football player is only a certain amount of time, so if you can play every major tournament of course every player wants that. In the bigger picture, we have to look at the calendar.
by DavidMek (2023-12-10 22:26)
‘I didn’t know what to say’: Wiegman praises England despite Olympic blow
Manager ‘proud’ but 6-0 win over Scotland was not enough
‘We really thought we got it, and then we didn’t make it’
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Sarina Wiegman said she “didn’t know what to say” to England’s heartbroken stars as they stood in a huddle on hearing the news that the Netherlands had scored a fourth against Belgium to knock them out of the Nations League on goal difference and end any chance of qualifying for the Olympic Games next year.
England looked to have done enough when Lucy Bronze’s late header capped a 6-0 victory against Scotland after 90 minutes of playing leapfrog with the Netherlands at the top of League A Group 1. But Damaris Egurrola’s 95th-minute goal for the Dutch earned them a 4-0 win minutes after England’s game had ended.
Alex Greenwood and Lucy Bronze console one another after hearing the news from the Netherlands.
England thrash Scotland but cannot avoid Team GB Olympic heartbreak
Read more
After the third Dutch goal in the 91st minute Wiegman, who had been relaying news of the score to the team via Bronze, who was nearest the dugout at right-back, urged them to go on the hunt.
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“I said: ‘We have to score now,’” she said. “We were pushing to score that goal anyway, because things can change any minute. So, then they scored, and we said now we have to go, we couldn’t play any scenario because there was no time, it was the end of the game, so she just ran forward, got the goal, that was really good, and I thought now we’re going to get it, but … it was not enough.”
England grouped in a circle, as hopes of Olympic qualification for Team GB died with England’s exit from the Nations League. Only the top two European sides and France as hosts will be at Paris 2024.
“We were waiting for some long minutes, and we really thought we got it, and then we didn’t make it,” the manager said. “I said I didn’t know what to say. All I could say was I’m really proud of our performance and what we did this whole week. But it’s not enough and it’s really, really disappointing.”
On whether there was a small silver lining in England’s players getting a summer off and some much-needed rest in an increasingly packed calendar, Wiegman said: “Well, you want to go to every major tournament. The career of a football player is only a certain amount of time, so if you can play every major tournament of course every player wants that. In the bigger picture, we have to look at the calendar.
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