Reflecting Again On GMP Requirements For Marketing Authorization Holder

By Geraldine Carr-Mulry

The European Medicines Agency (EMA) published its reflection paper entitled "Good Manufacturing Practice (GMP) and the Marketing Authorisation Holder (MAH)" in July 2021. This document serves as an important guideline for MAHs, as it aids them in understanding their GMP responsibilities, especially in instances where they may not have direct involvement in the manufacturing process.

The responsibilities of a Marketing Authorization Holder encompass several key areas, including audits and qualification activities, communication with manufacturing sites, product quality reviews, maintenance of the supply of medicinal products, continual improvement activities, and quality defects, complaints, and product recalls. Annex 16 emphasizes that Marketing Authorization Holders are ultimately responsible for the performance of a medicinal product throughout its lifecycle, including its safety, quality, and efficacy. Explore a practical way for MAHs to implement these responsibilities with their contract manufacturers.