About this document

ANVISA GMP Risk Classification SOP by Maike Reuwsaat is a document available to read on EtoBox.

This document outlines procedures from ANVISA (the Brazilian Health Regulatory Agency) for categorizing non-conformities and classifying establishments according to GMP regulatory risk. It defines establishment classifications of satisfactory, on demand, and unsatisfactory based on number and type of non-conformities identified during inspections. Non-conformities are designated as direct or indirect impact and can be increased by 1 point based on certain aggravating factors. Annexes provide examples of non

Author

Maike Reuwsaat

Language

EN