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Batch Record Documentation/Records vs. Inventory Records

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Quality Geek

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    United States

Posted 08 April 2021 - 08:11 PM

First, thank you in advance for any insight you are willing to provide!   :spoton: I am the Quality Manager for an FDA regulated facility that packages OTCs, food and cosmetics.  We are having an internal debate over the terms/ words used to describe 'there is no product left to package' and 'there is no packaging materials remaining'. I was taught to describe this as "consumed all bulk product" and "consumed all labels/ packaging".  However, my Inventory Management guy says these terms are only to be used when related to inventory.  My thought is yes, I am verifying there is no bulk product (in inventory) or, there are no more labels (in inventory).  As a compromise, I now record this verification as "no remaining bulk product" and "no remaining labels". Regulatory Peeps- What description/ verbiage do you use to document this verification step?  What feedback have you received in your experience from an Inspector? Looking forward to everyone's replies.

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Also tagged with one or more of these keywords: pharmaceutical, cosmetics, FDA records, FDA documentation, CFR 211, FDA regulatory

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