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Active pharmaceutical ingredients document requirements

The effects of cGMPs on submissions are only indirect and in two areas. First, GMPs serve as the source documents for quality audits of active pharmaceutical ingredient (API) suppliers, manufacturers, and processors. The revisions under development will have little or no impact on these audits assuming that standards in use include both the current GMPS and the automation issues addressed in 21 CFR Part 11, no changes will be required. [Pg.356]

Note Applicants who are dealing solely in hair dyes, die nostic kits, iaboratory reagents, veterinary products or who are involved in the manufacture of Active Pharmaceutical Ingredients, Bite not required to submit the abovementioned documents. [Pg.595]

See other pages where Active pharmaceutical ingredients document requirements is mentioned: [Pg.194]    [Pg.54]    [Pg.121]    [Pg.123]    [Pg.125]    [Pg.265]    [Pg.345]    [Pg.346]    [Pg.1580]    [Pg.4299]    [Pg.109]    [Pg.345]    [Pg.59]    [Pg.93]    [Pg.728]    [Pg.138]    [Pg.128]    [Pg.167]    [Pg.205]    [Pg.31]    [Pg.262]    [Pg.132]    [Pg.23]    [Pg.2]    [Pg.654]    [Pg.102]    [Pg.4]    [Pg.72]    [Pg.21]    [Pg.3]    [Pg.165]    [Pg.33]    [Pg.3]   
See also in sourсe #XX -- [ Pg.131 , Pg.132 ]



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