we are a cephalosporin unit and during the issuing of Process Validation Protocols we came up with the following inquiry:
Consider a Cephalosporin dry powder product A, which is being filled in a glass vial 1g.
Lets say that the dry API is being held to our facility by the manufacturer in three types of containers 5kg, 10Kg and 20Kg.
Lets also say that these are the batch sizes also deposited in the regulatory authorities for the specific finished product.
Should the Process Validation be conducted on three batches per batch size (of 5Kg, 10Kg, 20Kg) or should there be a matrix set up?
Could we for instance arrange so that the first three batches made are of the highest batch size (20Kg) and the Process Validation is only conducted on these three batches? Could we therefore write a rational in our protocol that the filling line is the same for all three batch sizes and that the worst case is that of the 20Kg due to the extra time that the filling will take place?
What should be our approach (if you agree with the above rational) if for some reason the API manufacturer does not have available the 20Kg container and send us a 10Kg container? Should in this case perform a PV only for one batch and wait until 20Kg containers are delivered so that to conduct the PV in three consecutive batches?
Thank you in advance.