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    Good Laboratory Practices (GLP) within the GxP Framework for Vaccine Manufacturing Implementation

    I. Introduction: Situating GLP within the GxP Framework for Vaccine Development A. Overview of GxP in the Pharmaceutical Lifecycle The development, manufacturing, and distribution of pharmaceutical pr...

    by • 20 Apr 2025
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    Penilaian Risiko Fungsional (Functional Risk Assessment – FRA) Menurut GAMP® 5 di Area GMP: Panduan Komprehensif

    1. Pendahuluan: GAMP® 5, GMP, dan Pentingnya Manajemen Risiko Lingkungan Good Manufacturing Practice (GMP) modern, termasuk manufaktur farmasi, laboratorium, dan uji klinis, sangat bergantung pada si...

    by • 20 Apr 2025

    Laboratory Information Management Systems (LIMS) in GxP Manufacturing

    The pharmaceutical and biotechnology industries operate under a rigorous regulatory landscape, where the integrity and reliability of laboratory data are paramount to ensuring the quality, safety, and...

    by • 25 Mar 2025

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