Hi everybody,
I have performed a cleaning verification on two batches of a drug product having a concentration of 33 mg/ml. Now, we are going to manufacture the same drug product but having a concentration of 1 mg/ml. Considering the fact that I have not completed the cleaning validation of the 33 mg/ml product, may I consider anyway not necessary to perform the cleaning on the 11mg/ml batch or, I have to perfor the cleaning verification on it?
thank you all.
Dear Marian…
When you are manufacturing same product with different strengths on a same equipment(s), it is better to select low concentrated product for validation, as a worst case scenario.
Dear Marianna,
you can find the answer at your question in the technical report 29.
In detail is reported the following sentence:
Group composed of several products having the same active ingredient. In this case, it would be reasonable to select the product having the highest
concentration of active since this product would present the greatest cleaning challenge.
The product with the highest concentration is the worst case scenario.
Because of the considerations described above, you can taking into consideration for your cleaning activities the concentration of 33 mg/ml and performed just one cleaning verification for the product with the strenght of 11 mg/mL. In this way you have validated the cleaning SOPs for the product with the concentration of 11 mg/mL since that have been verified 3 batches (two worst case 33 mg/mL and one 11 mg/mL).
Should you need any clarification, please don’t hesitate to ask.