Question posted on behalf of Jing Capucao
Is it current practice in your company to use non-commercial batches as primary batches for formal stability studies supporting proposed major changes to approved/marketed drug products? Or does your company’s practice allow commercial distribution of primary batches used in formal stability studies?
If your company allows commercial distribution of primary stability batches used in formal stability studies, are there requirements that need to be met prior to commercial distribution of primary batches, e.g. regulatory approvals, internal data/process requirements, etc.?
If your company does NOT allow commercial distribution of primary stability batches, are the primary batches full-scale batches?
Please provide any other comment or information you may have on this topic.
Jing Capucao
