What is the stability situation?

At 7:30 AM before I’ve even settled into the new week and barely got my laptop running, I get a call from a chamber technician that he can’t find the chamber use-log. For four years Frank has ensured our units are well maintained, and each month—which would be today—he reviews the use-log vs. the environmental monitoring system data to ensure that all excursions are documented. In the use-log, which is a numerically tracked research-type hardback notebook, we document all chamber activity not captured in other systems, which would cover about half of all chamber openings. Repairs and maintenance are documented in a separate system, placement of material in chambers is documented in the stability inventory system and sampling is documented in the LIMS.

Our internal requirements state to “routinely review chamber logs“ to account for all environmental excursions. Excursions less than 1 hour are defined as routine and exempted, however. Auditors have often asked if we accumulate excursion times and adjust study durations accordingly, but a confident “No” and a solid review of our procedures for handling excursions always satisfies them. But now, a lost use-log containing 6 years of documentation could call into question the integrity of our nearly 300 active studies.

Our program supports solid, liquid, oral and injectable small molecule pharmaceuticals primarily in the US market. In annual reports for each product we attest that the data support product shelf-lives by specifically stating that the material was stored as the “approved long-term storage condition” through that shelf-life.
Reality check—back to the lost use-log. Is it on your desk? Is it in with archived logbooks? Does another technician have it? All the common questions asked and answered—the book is gone. We aren’t specifically required to review chambers on a given day and we can create a temporary use-log if needed, but for now we’ll avoid non-routine door openings if possible while hunting it down. We’ll search high and low and get the word out, but in three days we’ll be required to initiate a deviation. Assuming it won’t be found, how can we justify the integrity of our current studies and demonstrate that data generated from them supports product in the field? What gaps in our program are exposed by this event?

How should this be resolved?

Current trends are away from paper logbooks and toward electronics to avoid the problems noted above. Physical logbooks might need to be locked to a chamber with tight control over keys and have a documented chain of custody.

Many companies track the movement of samples through an electronic chain of custody, which includes samples moving in and out of chambers. There are 483’s for lack of, or poorly kept logbooks, but providing solid justification to cover the process in other ways have been acceptable. Stability Stakeholders-What would you add to the discussion or selection of best course of action?

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