GMP & GDP Forum 2023

Agenda Day 1: GMP Forum | 20 June 2023



Introduction – Update ECA
Dr Afshin Hosseiny, Chairman of the ECA Advisory Board

Dr Ulrich Kissel

Session 1: Current GMP Initiatives and Trends

This session will discuss the latest changes and current initiatives in GMP and GDP regulations.

GMP Update 2023 and Outlook 2024 – Current Trends and Developments in Europe and US
Dr Bernd Renger

  • Regulation (EU) 2019/6 on Veterinary Medicinal Products – short feedback about the reduction of the use of antibiotics
  • Revised Directive (EU) 2017/1572 on GMPs for Medicinal Products & Delegated Regulation (EU) 2017/1569 & revised Annex 13 – short feedback about the differences of „human use Medicinal Products“ and „IMPs“
  • Reflection Paper GMP and Marketing Authorisation Holder (MAH) – Experiences
  • Revision of Annex 1 – Feedback from the industry
  • New Annex 21 – Experiences
  • Concept Paper Annex 11 – Goals of the revision
  • ICH Q2(R2) und ICH Q14 – Life Cycle of Analytical Procedures – Current status and feedbacks from the industry
  • Nitrosamines in Medicinal Products and APIs – Trouble for industry and authorities?

EMA: Update on Inspections, MRAs and Work Plan
Andrei Spinei

  • RIS Inspection System
  • GMP/GDP Inspectors Working Group – Priorities for 2023 and 2024
  • MRA current status and future activities
  • Harmonisation of Inspections in Europe

Session 2: Industry Meets Inspectors on Hot GMP Topics

Part A – The Revision of ICH Q9 Risk Management

ICH Q 9 Revision: Inspector´s view
Dr Rainer Gnibl

    • Overview
    • What is new?
    • Consequences in practice


Industry View: What does the ICH Q9 Revision mean for manufacturers ?– What QA (and QPs) need to know?
Dr Peer Schmidt

  • Background of guideline revision
  • Key changes
  • Impact on manufacturers
  • Examples for application

Part B – EU GMP Annex 11 on Computer Validation – EU Concept Paper on the upcoming Revision

EU GMP Annex 11 – The EU Concept Paper
Ib Alstrup

    • History of Annex 11
    • Why now a new version
    • Concept Paper


EU GMP Annex 11 – Industry view
Dr Wolfgang Schumacher

  • Importance of Annex 11 for the Pharmaceutical Industry
  • Industry view on Annex 11 Concept Paper

Part C – The New EU GMP Annex 1 – Consequences for QA

Annex 1 Revision: What does Industry has to expect? - GMP-Inspector´s view
Dr Rainer Gnibl

  • Contamination Control Strategy
  • (Re-) Qualification
  • Barrier Technologies & „old“ clean air equipment
  • News in material transfer
  • Sterile Filtration
  • Worst case for Aseptic Process Simulation

Annex 1 Revision: Relevant Points for QA – Industry view
Dr Ingrid Walther

  • Increasing relevance of Quality Risk Management
  • Contamination Control Strategy
  • Trending – the new Trend!




Click on the picture to open the complete programme as a PDF.