Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

How Good Manufacturing Practice (GMP) auditing impacts the quality part of the registration dossier for Active Pharmaceutical Ingredients

Maria Berlenbach (Abschlußjahr: 2024)

Summary
Language:  English
The purpose and general interest of this master’s thesis is to evaluate and highlight the importance of the role of Good Manufacturing Practice GMP Audit for the Marketing Authorisation of Active Pharmaceutical Ingredients. GMP responsibilities that apply to Marketing Authorisation Holders (MAHs).
For clarification, the European Medicines Agency (EMA) published on January 10, 2022, V02 a reflection paper focused on the responsibilities related to good manufacturing practices, outlining the GMP responsibilities of the MAHs.   This document is part of the EU GMP Part III: GMP-related documents. It contains the ICH Q12 whose regulatory environment may evolve towards greater flexibility around post-approval change management.
In recent years, product recalls and medicinal product shortages have put the focus on regulatory actions and highlighted the importance of quality assurance schemes. Quality assurance, Quality control, and regulatory affairs are highly emphasized in product shortage because it is a highly regulated system, and compliance requires professionals versed in regulatory frameworks, quality assurance, and quality control.  To highlight how GMP audits play a crucial role in the pharmaceutical industry, especially for MAHs of active pharmaceutical ingredients (APIs) during the quality part of the registration dossier.
Another purpose is to provide a perspective from the point of view of different departments that ultimately work together in Quality Assurance, Quality Control, and Regulatory Affairs by reviewing the GMP Guidelines concerning Quality Modules 2.3 and 3 Drug Substance-related and reflecting on the recent experience from the point of view of the industry, analyzing the important points to consider for successful results in a GMP Audit and the likely impact on the MAHs and Manufacturing/ Import Authorisation  (MIAH).
Pages: 81
Annexes: 5, Pages 10