Gaois

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  1. SOCIAL QUESTIONS|health|pharmaceutical industry

    #664636

    IATE #3592472
    eisíontas a bhaineann le próiseas Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    process-related impurity | process-related impurities
    en
    Definition impurity that is derived from the manufacturing process Reference "European Medicines Agency (EMA). 'ICH Topic Q 6 B Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products. Step 5. NOTE FOR GUIDANCE ON SPECIFICATIONS: TEST PROCEDURES AND ACCEPTANCE CRITERIA FOR BIOTECHNOLOGICAL/BIOLOGICAL PRODUCTS (CPMP/ICH/365/96)' (21.1.2021)"