Risk classification guide for drug good manufacturing practices observ…[100p]
100원
구매평
구매평
Risk classification guide for drug good manufacturing practices observations (GUI0023), (February 28, 2018)을 발표 했다.
-내용-
This document helps ensure consistency among Health Canada inspectors during drug establishment inspections when:
classifying good manufacturing practices (GMP) observations according to risk.
assigning an overall compliance rating to an inspection or to the paper review of GMP evidence.
It also informs industry of the situations Health Canada considers unacceptable that may result in a non-compliant (NC) rating and/or compliance and enforcement actions
-원문-
Risk classification guide for drug good manufacturing practices observations (GUI0023), (February 28, 2018)을 발표 했다.
-내용-
This document helps ensure consistency among Health Canada inspectors during drug establishment inspections when:
classifying good manufacturing practices (GMP) observations according to risk.
assigning an overall compliance rating to an inspection or to the paper review of GMP evidence.
It also informs industry of the situations Health Canada considers unacceptable that may result in a non-compliant (NC) rating and/or compliance and enforcement actions
-원문-