EIPG participation in the annual meeting between  Industry Interested Parties and the  EMA GMDP Inspectors Working Group

The European Industrial Pharmacists Group (EIPG) contributed to the coordinated preparations for the meeting between European interested parties and the European Medicines Agency’s Good Manufacturing and Distribution Practice Inspectors Working Group (EMA GMDP IWG), held remotely on 11 June 2026.

Through its participation, EIPG contributed the perspective of industrial pharmacists to the collective industry discussions concerning the development, interpretation and practical implementation of European GMP requirements.

Preparations began with the collection of proposed topics from September 2025, followed by the definition of topics and appointment of interested-party leads on 14 November 2025. The participating organizations subsequently worked together during the following months preparing  the meeting, the priority areas   and defining the  speakers during April and May 2026

The final agenda for the meeting of 11 June 2026 included:

  • The GMDP IWG work plan.
  • Inspection reliance and inspection coordination.
  • Annex 1.
  • GMP requirements for investigational medicinal products.
  • Chapter 1 of the EU GMP Guide.
  • Chapter 4 and Annexes 11 and 22.
  • Annexes 4 and 5.
  • Annex 6.
  • Annex 15.
  • Annex 19.
  • Good Distribution Practice topics

Concretely  EIPG contributed to the following priority areas:

  • EU-GMP Part II and active substances used in investigational medicinal products, including the interpretation of GMP expectations applied to investigational drug substances and active pharmaceutical ingredients.
  • Revision of Chapter 1 of the EU GMP Guide, including harmonised implementation, Quality Risk Management and the prevention of medicine shortages
  • Chapter 4, Annex 11 and Annex 22, covering key observations and implementation considerations
  • Annex 15 and validation approaches, including validation across related manufacturing sites, concurrent validation, digital transformation, artificial intelligence and continuous manufacturing.
  • GMP inspections and environmental considerations, in connection with the possible incorporation of environmental and sustainability considerations into future GMP guidance

EIPG’s involvement in this initiative demonstrates its continued commitment to ensuring that the expertise and practical experience of industrial pharmacists are represented in European discussions on pharmaceutical manufacturing and quality.

EIPG’s participation in this consultation process provides an important opportunity to bring the practical experience of industrial pharmacists into the European regulatory dialogue. Cooperation between professional and industry associations and medicines inspectors is essential to support GMP requirements that protect patients while remaining clear, harmonised and capable of effective implementation across pharmaceutical operations.