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Tag: excipient GMP guidelines EMA

EU GMP Requirements for Active Substances and Excipients

Posted on June 10, 2025 By digi

EU GMP Requirements for Active Substances and Excipients Complying with EU GMP Requirements for Active Substances and Excipients In the EU regulatory framework, ensuring the quality of both active substances (APIs) and excipients is a critical component of pharmaceutical compliance. The European Medicines Agency (EMA), through its Good Manufacturing Practice (GMP) guidelines, imposes clear requirements…

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EMA and EU GMP Inspection Practices, International GMP Inspection Standards and Harmonization

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excipient GMP guidelines EMA

  • EU GMP Requirements for Active Substances and Excipients

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