News about GMP/cGMP


EMA: Paper on GMP Responsibilities and MAHs

EMA: Paper on GMP Responsibilities and MAHs

On 23 July 2021, EMA has finalized its reflection paper on GMP-related responsibilities and marketing authorisation holder companies (MAHs). As various tasks are spread over different chapters and annexes of the EU GMP Guide and various directives, the paper now summarizes them in a single 29-page document. This is to provide clarity on which responsibilities are to be considered and what they signify for MAHs at a practical level.

The reflection paper also addresses the activities and responsibilities set out by the EU in the GMP Directives 2003/94/EC and 91/412/EC, as well as the relevant articles of Directive 2001/83/EC and Regulation (EU) 2019/6. In addition, aspects of the Falsified Medicines Directive and its delegated regulations are addressed. Not included are the GMP requirements for advanced therapy medicinal products (ATMPs), which are covered in Part IV of the GMP Guide.

To summarize all these aspects in their totality and what they mean for MAHs at a practical level is presented under a number of different themes:

  • Outsourcing and technical agreements
  • Audits and qualification activities
  • Communication with manufacturing sites (e.g. MA dossier information, variations, regulatory 269 commitments, etc.)
  • Product Quality Reviews
  • Quality defects, complaints and product recalls
  • Maintenance of supply of medicinal products
  • Continual improvement activities.

However, EMA states that the document is not intended to be an all-inclusive continued "reference list". This paper considers all reference documents up to and as of April 2019. It should serve as a useful resource for MAHs when designing (or reviewing) their internal systems as well as their interactions with manufacturing sites.

EMA: Reflection paper on Good Manufacturing Practice and Marketing Authorisation Holders