Stability chamber open and close logs

[anstab]

#22212

Historically, my companies have used a logbook to record when a stability chamber was opened and closed, what the temperature was at the time of opening and closing, the reason for accessing the chamber, who accessed/created an entry in the logbook, and who reviewed the logbook entry. I’ve always been told that this is an industry standard even when there is temperature excursion alarm monitoring, because you need to show the momentary changes in temperature or light exposure that a sample has experienced over time (i.e. a chamber may have never gone out of temp, but over many door openings over time a sample at T=6M may actually be T=5.75M due to disturbances opening and closing the chamber door). Does anyone know if this is a real requirement?

[John O’Neill]

#22549

Thanks for participating in the Situation Room Missing Chamber Log scenario. There are 483’s for lacking a chamber flow of custody showing that samples went in and out according to procedure and when, why, where and with whom they went. Many companies exempt door openings and in the case of the scenario, that practice had been successfully defended, but it’s a great “compliance confidence” builder if you can show the duration and impact of door openings in answer to what is becoming a more common question by regulators. These days, there are ample electronic solutions to monitoring these aspects. If budget and quality compliance priorities allow, electronic systems for inventory and chamber conditions/events are definitely on trend.

[Walter Routh]

#22550

So, as far as guidances, no, I’m not aware of a specific requirement to have open/close logs, but as was previously stated, chain of custody and sample integrity are requirements. As such, some access control or documentation would be part of that, but I’m surprised at the details being documented. I believe simply a name and time should be sufficient since the temperature at that time should already be noted, assuming you’re continuously monitoring (a requirement). Also, it seems unnecessary to document the reason for entry since presumably access is limited to qualified personnel and they’re performing routine stability activities. Either way, the reason is immaterial to how the chamber behaves.

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