Hi,
How can we perform cleaning validation for a multivitamin multimineral formulation. Is there any regulatory guidelines which says about cleaning validation of this formulation? If so kindly share the same.
I am also not aware how it can be performed when we are adding the vitamins and minerals in a low concetration. Is it required to perform the analysis for all the actives (vitamins and minerals in it) or we can select the any one of the maximum concentration in the combination?
Is it mandatory to perform cleaning validation of a multivitamin mineral products if so kindly share the document
Please guide me as I cant find any answer about cleaning validation methodology of a multivitamin, multimineral products & the limits for the same.
Thanks in advance.
For vitamins use TOC (see articles on my profile) and for minerals you need ICP-MS.
No! Only, certain vitamins are toxic at high concentrations and thus require a 'risk assessment' that includes the ADE (acceptable daily exposure). The concentration of minerals in a formulation is mandated in the US CFR (code of federal regulations). Use a TOC analyser.
What do you mean by "cleaning validation" of a a multivitamin / minerals formulation.
In many countries such formulation is considered as over the counter medicin. But even these OTC formulations need to be registered and an application file (depending on the national laws) will be needed.
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