Home › Forums › General Discussion › Is there guidance or an industry standard for pull windows (+/- number of days)? › Reply To: Is there guidance or an industry standard for pull windows (+/- number of days)?
Excellent question and a timeless bugaboo for Stabilitarians. I’m not aware of a specific guidance on this aspect of pull points, and common practices have been governed by what companies have executed without regulatory citations and those instances where regulatory input influenced a company to follow a very specific (and almost always) tighter policy. For example, one company which had practiced a +/- 7 day window had an FDA inspection and following a citation (not based on Guidance, but what the inspectors called an expectation of good practice), revised their policy to No Early Pulls and a Late Pull limited to “Next Business Day”. Other companies have gone through inspections where early or late pull policies were justified with data showing that no more than insignificant changes would occur because of the pull shifts. Many of those justifications were accepted.
All that to say, that Pull ranges should be kept to the tightest practical window and there should be solid scientific justification for the policy you apply. In general, early pulls can raise a red flag for inspectors and very late pulls can raise issues of control in your practice. Working with your QA and Regulatory colleagues will help you arrive at an appropriate comfort level with the pathway you choose.
I would suggest contacting some of the larger LIMS providers about study-specific pull windows in their software. Since some companies apply a sliding scale to various types of studies, or even early vs. late stage of study, I wouldn’t be surprised if there could be study-specific windows, though I have never personally seen that in practice.
So, Stabilitarian audience, What response would you give to the writer?