[RegAffairs]Re: QC reporting to production

["Ketan Agravat" <ketan.agravat@unimarkremedies.com>]

I hope it's not late.

I found risk classification at the following link
http://www.hc-sc.gc.ca/dhp-mps/alt_formats/hpfb-dgpsa/pdf/compli-conform/gui
_23_e.pdf (Canada guideline)

"QC department not a distinct and independent unit, lacking real decisional
power, with evidence that QC decisions are often overruled by production
department or management."

As per guide this is classified as critical risk.

Best Regards,
Ketan Agravat