Introduction – Update ECA

Dr Afshin Hosseiny, Chairman ECA


GMP PART - 22 June 2021

Moderated by: Lance Smallshaw

SESSION Current GMP Initiatives Worldwide

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

GMP Update 2021 and Outlook 2022 – Current Trends and Developments in Europe and the US

  • Major GMP developments and their impact for pharmaceutical industry
  • GMP Revisions – Annex 1 & 21
  • GMP for Marketing Authorisation Holders
  • The new EU GMP Annex 21 on Importation and its implication
  • Analytical Procedure Development and Validation (ICH Q14/Q2)
  • Other GMP Developments from EMA, FDA and others
  • Brexit and its consequences for the European QPs

Dr Bernd Renger, QP and immediate past chair of the EQPA

ICH Q 12: Views and Expectations of a GMP-Inspector

  • Quality Risk Management
  • Life Cycle Approach
  • Views and Expectations

Dr Franz Schönfeld, GMP Inspector

How to Implement ICH Q 12 into Daily Practice of Manufacturers – What QA (and QPs) needs to know?

  • What does QA (and QPs) need to consider?
  • Some Quality systems become key
  • Efficiency potential for Quality systems of manufacturing organizations
  • ICH Q12 and key performance indicators
  • Plan precisely, assess risks proactively, share transparently

Dr Ulrich Kissel, Chairman European QP Association

SESSION Industry Meets Inspectors

GMP Inspections from Russian Authority in Europe

To be named

Global Inspection Management: Cultural Diff erences to consider in hosting Competent Authorities from e.g. Arabic Countries, China, Korea, Taiwan, Mexico, Russia

  • General Organisation
  • Roles and Responsibilities
  • Preparation
  • Cultural Aspects

Helga Peters, Basel, Switzerland

Annex 1 Revision: Comments from the Industry

  • New requirements? 
  • New requirements!
  • The role and improtance of Quality Risk Management 
  • Contamintation Control Strategy

Dr Ingrid Walther, Head of ECA´s adhoc Task Force for comments to the Annex 1 revision

Inspection – readiness for new Annex 1: Comments from the Inspector

  • What is essential?
  • What do I need to change or improve?
  • Is it really such serious?

Dr Rainer Gnibl, GMP Inspector

Final Q&A session (Day 1)