Home Forums General Discussion How early can you pull stability samples? Reply To: How early can you pull stability samples?

John O’Neill
Moderator
Post count: 73

I would agree on minimizing the practice of early pulls. In cases where a company is willing to take the risk of regulatory notice, an early pull (event or procedure) should be justified with as much scientific, regulatory or best practices input as possible. Internal QA and Regulatory approval should back whatever practice is pursued and be prepared to defend it in an inspection.