What documentation is available for the CTD (Common Technical Document)?

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GMP, or Good Manufacturing Practices, are a set of official production standards and as such only make sense when the appropriate reference is indicated. Probably the most widely recognised GMP standards for active ingredients are the ones defined by the US FDA under  legislation  21 CFR, part 210-211. For instance, ROQUETTE’s LYCADEX PF has been assessed on a repeated occasions and has met these standards. However, there are other institutions that have set different GMP guidelines, such as WHO and IPEC.  The question of GMP certification has to be considered in the context of the specific product and local regulatory requirements.

For more information on this issue, please contact us or your local representative.

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