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)?

Walter Routh
Participant
Post count: 8

Short answer–No, there is no industry standard. I came from a long history of strictly no early pulls. That requirement, however, came from a very old FDA audit observation and the program was terribly out of control at the time with very inadequate procedures. After several PSDG meetings even from 10 years ago, I was pushing to loosen that requirement in our program to allow early and late pulls on a sliding scale based on the age. The last pull should always be exactly on the date, however (or very very close). Back over 20 years ago, the issue from an audit perspective was the appearance of pulling a sample earlier in order to “help” it meet specification, so your procedures need to give strong scientific/statistical justification for your window, if allowing wider pull windows. That said, I was never able to implement a wider pull window. We wanted to primarily to enable more testing efficiency (it increases the abiltiy to pool testing together across multiple studies (if they’ve started just a few days/weeks apart). But, our systems and resources were just not able to monitor, track and plan future pulls adequately. We were more afraid of missing pulls among the chaos.