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On the ECA Academy website you have all the important information for your daily work in the GMP/GDP environment directly at hand: current news, suitable online training, eLearning offers, conferences, seminars and courses, a comprehensive guideline database and many other services. Should you not find what you need, just contact us by phone at +49 (0)6221 / 84 44 0 or send an e-mail to info@gmp-compliance.org.

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GMP News

Public Consultation on Key Information in the Package Leaflet

The European Medicines Agency (EMA) has launched a public consultation on a potential Key Information Section in the Package Leaflet (PL) of centrally authorized medicinal products. The EMA would like to invite all interested stakeholders to respond by 31 May 2025.

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QP Declaration: New Q&As published

The European Medicines Agency (EMA) has published a Q&A document on how third-party audits should be reflected in Part C of the QP Declaration.

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FDA Warning Letter on missing Audit Trails and Raw Data Review

Among other things, the lack of verification of the electronic raw data and the audit trail led to a warning letter to a south african company. What did the FDA criticise?

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