Non-approved supplier?

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Seasides

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#1
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A few non-approved vendors/suppliers came to our site to perform IOQ on equipment. These equipment are not in GMP use yet. Management thinks of writing a Non-conformance (minor). What's the best way to resolve this in pharma/biotech?
Thank you.
 
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chris1price

chris1price

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#2
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Management are probably working along the correct lines. Depending on your systems, either a non-conformance, deviation or CAPA is probably appropriate. Then within the deviation include a risk assessment on why the non-approved supplier was acceptable, root cause of how did it happen and how you will stop it happening again.
 
John C. Abnet

John C. Abnet

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#4
#4
Seasides said:
A few non-approved vendors/suppliers came to our site to perform IOQ on equipment. These equipment are not in GMP use yet. Management thinks of writing a Non-conformance (minor). What's the best way to resolve this in pharma/biotech?
Thank you.
Click to expand...
Good day @Seasides ;
What is the gap? What is the nonconformance?
(i.e. is there a rule against non-approved suppliers being on site for validation?
The equipment is not yet in production. Will these suppliers BE approved?

A nonconformance should be written on a gap to a requirement. I'm struggling to understand the requirement (and thus the gap) based simply on your original post .

Be well.
 
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