Active Traces Sampling for Same Product Different Potencies

Hello All:

I have to validate the cleaning process of an equipment train that is used to manufacture the same product (same API), same excipients but different lot sizes/ API amount per product presentation. That is Product A strenght 5mg and Product B strenght is 250mg and they are NOT manufactured using a common blend.

The validation requirements according to the site procedures is visual inspection, micro testing and chemical residues (for non dedicated equipment only).

Should I consider these as two different products and validate the cleaning process using the Product B (visual, micro and chemical) or consider Product A and Product B as the same product and validate the cleaning process with visual and micro only? :confused:

Thanks in advance for your help

Select the worst between the two, of which in this case, the product with higher strength should be your worst case.

Thank you for the information.

I understand that I have to select the worst case among the products manufactured in the equipment. However, my doubt is really what is considered “same product” and if active traces are applicable or not.

Product A - tablet 5mg vs Product B - tablet 250mg.

Both products are made from the same API and same excipients but the proportion of excipients vs API and the lot size is different.

For the execution of cleaning validation activities, shall I test for active traces once I complete the cleaning after the manufacturing of Product B (tablet 250mg)? Is there is a possibility that the subsequent manufacturing of Product A (tablet 5mg) could be considered adulterated due to Product B traces left in the equipment?


Shall I consider that since these two products are made from the same API and excipients, there is no need to consider Product A and Product B as two different formulations? If so, for cleaning validation purposes, the plant SOPs only ask for visual and micro and API traces are not required to be taken.

Thanks a lot for any information provided. :slight_smile: