Programme: ECA's new Integrated Qualification and Validation Guide

Working with Suppliers towards modern Qualification and Validation

Day one - 8 October 2019

 Gert Moelgaard

Introduction to Integrated Qualification and Validation

Gert Moelgaard, Head of ECA´s Validation Group

  • Development of ECA's Integration and Validation guideline


 Dr Chris Watts

Modern Qualification and Validation from an FDA perspective

Dr. Chris Watts, VoPal

  • FDA’s Process Validation guide
  • Process Validation as a life-cycle approach
  • Lessons learned from the FDA Process Validation guide
  • International harmonization of process validation?


 Klaus Eichmüller

Qualification and Validation requirements from a European inspector´s view: Possibilities to integrate Qualification and Process Validation Activities

Klaus Eichmüller, EU Inspector, Wolnzach c/o Regional Council Darmstadt

  • Qualification and Validation requirements in EU Annex 15
  • The importance of good cooperation between customers and suppliers
  • Qualification observations from an inspector's view
  • Possible problems in future?


 Ger Moelgaard

Introduction the ECA Guideline: Integrated Qualification and Validation - A guide to effective qualification based on Customer - Supplier Partnership

Gert Moelgaard, Head of ECA´s Validation Group

  • Content of the guideline
  • Application of the guide by suppliers and users
  • Fit into the GMP regulations
  • Benefit for involved parties


 Peter Werner Christensen

ISPE Commissioning & Qualification guides: From version 1 (2001) to version 2 (2019) - and other related guides

Peter Werner Christensen, Cook Medical

  • What is ISPE?
  • ISPE Baseline No 5 Commissioning and Qualification from 2001
  • Bridging Baselines
  • New ISPE Baseline No 5 Commissioning and Qualification, version 2 from 2019


 N.N. - Jettaconsortium

JETT Consortium – how to deal with example forms

N.N., Jettconsortium

  • Origins of JETT
  • Adoption of GAMP Guidance
  • Initial Work
  • URS Development Method
  • Workers vs. Clingons
  • Works Produce


 Dr Clemens Borkenstein

Equipment Categorisation - one way to efficient Qualification

Dr Clemens Borkenstein, ZETA

  • Equipment categorization helps to select an appropriate effort for qualification activities and helps to avoid excess work
  • The perfect timing for equipment categorization during design phase in a customer supplier partnership
  • Explanation of the 3 types of equipment categories for pharmaceutical industrial plants including practical examples
  • Easy do-it-yourself categorization of pharma equipment depending on general quality risk impact), product and process critical aspects, technical, complexity of the process as well as supplier capabilities

Day two - 9 October 2019

 Ralf Gengenbach

Good Engineering Practice – A key to leverage the quality system of a good pharma equipment supplier

Ralf Gengenbach, Gempex

  • Key elements of GEP with relevance for GMP
  • First approaches of ISPE and ASTM and their results
  • How far suppliers are allowed to execute the qualification
  • Some ideas how to integrate GEP documents best
  • Why is there still a headache?


 Rolf Bauer

Case Study: Current Factory Acceptance Test (FAT) – market approaches between tradition and state-of-the-art

Rolf Bauer, Bosch

  • FAT requirements requested by User Requirement Specification
  • Pre-requisites for FAT execution
  • Implementation of FAT results into qualification
  • FATs vs SATs
  • Good practices for successful FATs


 Dr Thomas Schneppe

Qualification and Validation: An integrated approach

Dr Thomas Schneppe, Bayer Pharma

  • Process Qualification - the „marriage“ of qualification and process validation
  • Integration of critical process parameters into qualification
  • The real goal is PPQ
  • Key performance indicators in qualification and validation (Cm, CmK, Cp, CpK, Pp, PpK)


 Peter Larsson

Case Study: Transforming Novo Nordisk´s qualification and validation concept to focus on GEP and supplier collaboration

Peter Larsson, Novo Nordisk A/S


 Gert Moelgaard

Feedback to the Integrated Qualification and Validation Guide

Gert Moelgaard, Head of ECA´s Validation Group

  • Open questions
  • Outlook


 Panel Discussions

Panel Discussions
Panel discussions with regulatory authority and pharmaceutical industry ensure the transfer from theory into practice.