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Batch Record Documentation/Records vs. Inventory Records

pharmaceutical cosmetics FDA records FDA documentation CFR 211 FDA regulatory

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#1 Quality Geek

Quality Geek

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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.







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

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