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規制動向

FDA、EMA、TGA および世界の規制動向

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UPDATED
規制動向
2026年8月24日•1分で読めます
FDA Identifies GMP Violations Affecting Sterility Assurance
An FDA inspection uncovered GMP violations that may compromise product sterility and quality, prompting a recall.
UPDATED
規制動向
2026年8月24日•1分で読めます
FDA Recall: CGMP Deviations Due to Intermittent Temperature Excursions
The FDA has issued a recall citing CGMP deviations caused by intermittent temperature excursions during storage.