Could you let me know asnwers of following questions to understand validation better ;
1-what tests are going to be included or excluded? How i can know them if a new product will be validated (granulation,tablletting and coating processes)?
2-What tests are going to be required ? Where i can find required tests for validation (granulation, tabletting and coating processes)?
3-how can i decide sampling frequency and amount of sampling? if i take samples more than i required it can be a deviation?
4-we are performing blend uniformity tests in granulation step but our acceptance criteria are written as “only for information”. Our costumer doesnt want to accept these criteria, how can i convince them about this criteria? (there is no deviation or no problem occurred during validation)
please let me know answers of these questions for solid drug production.
thx in advance