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Drug development validation history

Manufacturing process The descriptions of the manufacturing steps for the drug substance and product should include process flow diagrams and discussions of critical scale-up steps and process development history and process validation activities, together with assessment of the equivalence or differences in batches used for various studies. [Pg.103]

See other pages where Drug development validation history is mentioned: [Pg.228]    [Pg.1221]    [Pg.828]    [Pg.95]    [Pg.776]    [Pg.402]    [Pg.48]    [Pg.437]    [Pg.487]    [Pg.123]    [Pg.59]    [Pg.401]    [Pg.160]    [Pg.191]    [Pg.320]    [Pg.20]    [Pg.1559]    [Pg.407]    [Pg.16]    [Pg.519]    [Pg.923]    [Pg.172]    [Pg.333]    [Pg.91]    [Pg.199]   
See also in sourсe #XX -- [ Pg.186 , Pg.188 ]



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