The Quality Lowdown: Coronavirus Prompts EU To Extend Comment Deadline For Annex 1
Industry gets time to craft more objections to EU GMP PUPSIT provision, excipient data integrity advice offered, FDA MAPPs revised, US hits Health Solutions while EU hits Dishman Carbogen, and 11 added to FDA drug GMP import alert.
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Inter-associations working group suggests changes to the EU GMP Annex I revision to make it easier to understand by health authorities worldwide; the groups point out that the annex will be used globally and not just in Europe.
Despite improvements, latest EU GMP Annex 1 revision draws another round of objections to PUPSIT filter testing provision.
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