Guidance for Quality Assessors –Drug Substance (Ver 1.0, finalised June 2017)
This document is primarily intended for Quality Assessors within Regulatory Agencies to facilitate the preparation of the Quality Assessment Reports (QARs), by providing guidance and assistance to Quality Assessors in the review of the technical information contained in the Quality Module (Module 3) of Active Substance Master Files (ASMFs)/Drug Master Files (DMFs) and marketing authorisation applications (MAAs).
In line with IPRP’s broader objectives, the IPRP believes that the publishing of this guidance may also be of benefit to national regulatory agencies who are not members of IPRP, and to parties responsible for the preparation of quality information that is submitted to regulatory agencies.
It should be noted that this document outlines the recommended components in the evaluation of the Quality Module. It is acknowledged that during the assessment, there may be additional components to be considered by each regulatory agency beyond this guidance depending on their legislative/regulatory/policy requirements and review practices.