Annual Chamber Inventory and Reporting

[sfroment]

#22539

I would like to know how everyone performs and reports their annual chamber inventory.

[Walter Routh]

#22540

The stability program I managed only required a periodic (quarterly) spot check to ensure the inventory systems are functioning. That spot check was proceduralized and documented as an “Internal Audit” activity which was out of scope for external audits (and even internal audits). If an auditor wanted to see that documentation, we could give them an affidavit confirming the spot check was performed, but not the actual raw documentation. That said, our spot check was a check list of several compliance and maintenance related things and a simple list of 10 studies counted for accuracy of inventory. If more than 1 item was inaccurate of if two periods in a row showed problems, an immediate full inventory was conducted of that chamber. If more than more than one chamber in two periods had inaccuracies a full inventory was conducted. We have only conducted a full inventory once in 12 years.

That said, annual chamber inventories are, in fact, not a requirement, and in my opinion, they are an area where many programs spend too many resources for very little return. An auditor is interested is accuracy of your inventory during their visit and should not be interested in the accuracy of your inventory 18 months ago during the 3-day shutdown. If you have a modern LIMS system that updates inventory automatically as samples are added or removed with each transaction verified then apart from an actual thief coming in, your inventory should remain accurate for the life of each study. Confidence in that system can save a lot of time and money.

[John O’Neill]

#22541

Annual Chamber Inventory and Reporting is all over the map for our industry. I’m not aware of a specific guidance that spells out how this task is accomplished and reported, but it is a GMP expectation that you control and know the number of samples in your process. It’s not unusual in the flow of Stability life with multiple transfers and LIMS “book keeping” that someone creates an error and you find your count may be off by one or two. It’s not unheard of that companies who have not prioritized good inventory practices may be starting out with errors numbering in the hundreds. The key is to have a system in place to discover and remediate discrepancies in a timely fashion. Your CAPA system should result in a downward trend in inventory errors.
Some companies perform annual inventories, some do rolling inventories (a different chamber or condition each month), and a few claim a “validated process” that doesn’t allow errors. I’ve found that “emergency inventories” like those conducted with the FDA on the doorstep, often carried out with untrained volunteer colleagues can result in even more errors than when you started. Inventorying frozen materials is problematic as well, since the process involves frequent chamber openings and some time out of refrigeration while counting.
My preference would be to conduct stability studies with samples in tamper-evident shelf cartons in predetermined numbers (such as 100 per carton) That way a count of say 479 samples would involve counting 79 samples added to 400, representing the 4 sealed (but breathable) cartons of 100 each. The inventory count is updated whenever there is a pull point. That way, each study is counted annually at a minimum and more frequently when multiple pulls may bring a higher risk of error. It also minimizes the need for extra staff required to do large scale inventories. Since the Sample handlers will already be counting the samples being removed, It only takes a few more minutes to count the remaining samples and reconcile them with the projected numbers. Any deviations get investigated and remediated, noting any emerging trends for the CAPA folks. If I were a Regulatory official, I would be impressed with any system that keeps a close eye on inventory and produces a downward trend and holds it at rock bottom for errors.
What do others in our StabilityHub community have to say on the subject?
John O’Neill

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