Cleaning validation

Validation
1

I did read the pharmaguideline article about concentration of API (Identification of Worst Case in Cleaning Validation). It says the product having higher API concentration is the worst-case.

Hipothetical Example:
Some medicine has paracetamol api 500 mg plus other api maleate of chlorfeniramine 4 mg. So is the worst case the paracetamol api ? I tried to find ich cleaning guide, gmp cleaning guide. They don’t say nothing about higher api concentration for worst-case how do we assume that ? I’m studying about this topic and i got very curious. Thanks.

2

It is better to put the link of the mentioned article

3

Sure my bad.

1 Like
4

I saw what is in the link

I think the link “in point 5” is comparing between products having “the same API”

Kind regards

5

Hi, Can any one suggest the rationale for selection of rinse solvent used for establishing recovery factor in QC & Plant equipment.

Regards,
Sandip