GMP & GDP Forum 2023

 

Welcome

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

Moderator
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!