EFPIA:2025年年度监管GMP/GDP检查调查数据报告(英文版).pdf |
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Onsite inspections are the norm; 'remote' inspection remain as back up optionThe implementation of GMP Annex 1 did not increase the number of inspections at sterile manufacturing sites of medicinal products nor APIs Continued supply: No site reported interruption of supply as of inspections'For cause': Numbers are decreasing & still result in no interruption of supplyAnnounced or unannounced inspections yield similar outcomes
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