Current role of gmp audit for marketing authorization API

Abstract

In this type of work a comparative study on marketing authorization application (MAA) representation for Preparation of Drug
master files (DMF) in Europe for Active pharmaceutical ingredient (API) was reviewed thoroughly. The MAA representation
DMF is required. This document provides the regulatory authority with confidential information regarding facilities, processes in
a manufacturing unit. In this work all types in a DMF is included. The work focused on the preparation of DMF’s for API. The
dossier required for the CTD also included. The data required for DMF with their serial classes are mentioned. The study on
EDMF and the particulars are listed.