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John O’Neill
Moderator
Post count: 73

Generally, there is a regulatory “expectation” (not a guidance requirement, but they do issue 483’s for not meeting expectations usually conforming to industry best practices) to complete most testing within 30 days of pull point. That said, there are reasons to stretch it for things like certain microbiological / sterility tests or shrink it for tests on product parameters that change quickly once a sample is removed from its storage environment. I have heard of stacking pull points to conserve resources, but find that to be very risky without scientific justification and i’ve never seen it promoted in literature or guidance. I have seen 483’s and repeat 483’s followed by a Warning Letter for a company that failed in the long term to improve their test completion stats to a limit of 30 days. The goal should be to impliment practices and resources to achieve consistent completion within 30 days or less. Do some of our Stability colleagues have input or experiences they would like to add to this discussion?