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John Adair

QA Ownership of SOPs in a GLP compliant system

Has anyone heard of a GLP requirement that restricts the QAU (Quality Assurance Unit) from being the owner of any SOP in the document control system?
I'm being told by some that the FDA (only in GLP environment) will "write us up" if we allow QA to own SOPs. By this I mean that QA has SOPs that they are responsible for in our 2 year review process.

Views: 8

Tags: GLP, QA

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John Adair Comment by John Adair on August 12, 2010 at 8:26pm
Ana Maria,
Sorry for the delay in replying. I have not checked this site since I registered. I have resolved the issue. Thank you for your input.
Please join me on LinkedIn.
Ana Maria Rodriguez-Rojas Comment by Ana Maria Rodriguez-Rojas on March 30, 2010 at 10:34am
I've never heard of this before. Interesting. I look forward to this discussion.
Ana Maria Rodriguez-Rojas Comment by Ana Maria Rodriguez-Rojas on March 25, 2010 at 4:37pm
Define "owning" an SOP?

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