As per ICH Q1 A(R2):
Data from stability studies should be provided on at least three primary batches of the drug product. The primary batches should be of the same formulation and packaged in the same container closure system as proposed for marketing.
This requirement is well understood for ongoing/annual commercial stability.
Does it mean that primary stability studies should also be conducted on fully packaged product and not on the naked vial or PFS primary containers?
please provide your guidance.
