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ISO 9001 and VWAD (Verified-Accredited Wholesale Distributors certification)

I

Ian T

#1
#1
I am assisting a pharmaceutical company with their QMS documentation for ISO 9001 certification. They are also applying to VAWD (Verified-Accredited Wholesale Distributors certification)
Based on ISO 9001 I am creating SOPs and processes and integrating VAWD criteria into those documents. The documents will reference VAWD due to content. For nonconforming product, damaged good, Suspect or illegitimate products, these scenarios still fall under a nonconforming material report/CAPA?

Thank you.
 
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skb76

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#2
#2
hi!

Just give opinion , in case of iso9001:2015;

p/s refer
~clause 8.7 (Control of nc outputs)
~clause 10.2 (NC and corrective action)
(#based on my personal experience, all nc should be reported, corrected/improvement and 'documented')
moreover, as u written, you have created the SOP for these process/procedure)

and IF is incoming products,
p/s refer
~clause 8.4.2(as well)
 
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