We would like to perform the cleaning validation of an equipment that is commonly used for two API’s which are topical applications. For the calculation of MACO, where can we get the LDD value for the active that is used to prepare ointments. Or is there any other way to calculate the MACO.
Since you are already producing products with these two APIs then there must be a leaflet approved by your regulatory affairs for each product. Having chosen the worst case product (i.e. API) in the leaflet of the product there must be a LDD declared. This one can be used for your clarifications.
Best regards,