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Tag: EMA quality regulations

Pharmaceutical Quality and Practices: Foundations of GMP and Regulatory Excellence

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Pharmaceutical Quality and Practices: Foundations of GMP and Regulatory Excellence Pharmaceutical Quality and Practices: Foundations of GMP and Regulatory Excellence Introduction Quality is the backbone of pharmaceutical manufacturing and regulatory compliance. Ensuring the identity, strength, safety, and efficacy of drug products requires a robust and continuously evolving Quality Management System (QMS). Regulatory agencies such as…

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Pharmaceutical Quality and Practices

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  • Include In-Use Stability Studies for Reconstituted and Multidose Formulations

    Understanding the Tip: Why in-use studies are essential: In-use stability studies evaluate how a pharmaceutical product performs after it has been opened, reconstituted, or prepared… Read more

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