Jump to content

  • Quick Navigation
Photo

Batch Record Documentation/Records vs. Inventory Records

Share this

  • You cannot start a new topic
  • Please log in to reply
No replies to this topic

Quality Geek

    Grade - Active

  • IFSQN Active
  • 5 posts
  • 0 thanks
1
Neutral

  • United States
    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.


  • 0



Share this


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

1 user(s) are reading this topic

0 members, 1 guests, 0 anonymous users