Guidance for Quality Assessors –Drug Product (Ver 1.0, finalised May 2020)
The purpose of this document is to provide guidance and assistance to new and existing Quality Assessors in the assessment of the technical information contained in Drug Product Quality Module (Module 3.2.P) and to facilitate the preparation of Quality Assessment Reports (QARs).
This guidance document reflects information on the assessment of data contained in marketing authorization applications for chemical entities; it does not include guidance for the assessment of biologicals / biotechnological products.
This Guidance for Quality Assessors follows the format and terminology recommended in ICH’s CTD-Q guideline. This guidance is structured to provide recommendations on the preparation of the Quality Assessment Report (QAR), as indicated by “Information to be stated in the QAR”, followed by further guidance to assist Quality Assessors in the assessment of the technical information, as indicated by “Points to be considered during assessment”.
It should be noted that this document outlines the recommended components of an evaluation of the Drug Product Quality Module (Module 3.2.P) of the application. It is acknowledged that there may be additional components to be considered by each regulatory agency during the assessment of the Quality Module beyond this document, depending on each regulatory agencies’ legislative/regulatory/policy requirements and review practices.