How early can you pull stability samples?

[John O’Neill]

#24975

Posted for an industry colleague.

When people pull stability samples, they often determine a “pull window”. How early do you know that people typically specify allowing pulling?

[Walter Routh]

#25022

For fear of appearing too lenient, or for fear of appearing as if they might be pulling a sample early “to make it pass”, many companies shy away from early pulls altogether. I’ve heard of several that do pull early, and the key is that whatever they do is specifically described in a procedure. That said, the expiry interval and the final interval should always be pulled on or after the date. For other pulls, I’ve heard of companies pulling up to 2 weeks early, though I’d recommend that be only for later (> 1 year?) pulls.

[John O’Neill]

#25024

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.

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