Review of "Key Data" for contract labs, but SOP doesn't define "key data". Problem?

R

Robert in SF

#1
Quick question:

Do you know of any specific pharma guidances, regs, 483, warning letters, etc.., to support an audit observation that a company using a contract test lab and only reviewing "key data" per their SOP, but does not define or provide any guidance/training on what *is* "key data"...to ensure consistency across reviews and reviewers.

The company outsources some QC testing.
The company may choose to reduce the review of the QC data by the contract lab, once the lab has a solid history of good performance (per an SOP).
But, the SOP says that the company still reviews "key data" but doesn't specify what that entails, and doesn't have specific training or guidance on what that means.
I am concerned it's an Inspection Observation risk.

Any 483s, warning letters, guidances, etc.. that I can point to, to support my raising the issue?

Google has not been my friend, since the various terms that companies may use means I am drowning in search results...I am still looking, but maybe you know of something off the top of your head?
 
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Stijloor

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Super Moderator
#2
Re: Review of "Key Data" for contract labs, but SOP doesn't define "key data". Proble

A Quick Bump!

Can someone help?

Thank you very much!
 

v9991

Trusted Information Resource
#3
Re: Review of "Key Data" for contract labs, but SOP doesn't define "key data". Proble

"what" ..."key data" is usually defined in the responsibility matrix on quality/technical agreement;

refer the responsibility matrix and scenarios defined in the quality agreement related guidance document, which provides enough emphasis roles and responsibilities
Contract Manufacturing Arrangements for Drugs: Quality Agreements
..Quality Agreement Guideline & Templates..

VENDOR QUALIFICATION

Technical/Quality Agreements | IVT

....

and one more point, this is not important because of inspection-risk; this is important wrt ownership, accountability on the activity. :2cents:
 
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