Qualification and Validation Forum Release of ECA´s new Integrated Qualification and Validation Guide - Version 2.2

Qualification and Validation Forum

Heidelberg, Germany

Seminar Nr. 20368

This course is part of the GMP Certification Programme "ECA Certified Validation Manager". Learn more.



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Rückfragen unter:
Tel.: 06221 / 84 44 0 E-Mail: info@concept-heidelberg.de


Rolf Bauer, Syntegon
Dr Clemens Borkenstein, Zeta
Holger Frey, Merck
Ralf Gengenbach, Gempex
Dr Rainer Gnibl, District Government of Upper Bavaria
Maik Guttzeit, Bayer
Axel Heueis, Drees & Sommer SE
Igor Krasula, Valicare (a Syntegon Company)
Jörg Zimmermann, Vetter Pharma-Fertigung


Qualification and Validation regulations have changed in both Europe and USA in recent years. Many pharmaceutical companies and suppliers are still using methods and documentation from previous practice although a risk-based approach has become a regulatory expectation since years. Also, many companies have very little integration between their activities and suppliers activities, so the overall qualification and validation effort is complicated, expensive and time consuming. Only few companies have leveraged their qualification and validation programs to a fully integrated approach, as the EU Annex 15 and the FDA Process Validation guide emphasizes.
This Forum is about time saving integrated qualification and validation activities, where suppliers are an important factor in this modern approach.
A team of pharmaceutical companies, engineering companies and suppliers have developed and further optimized ECA`s Good Practice Guide “Integrated Qualification and Validation – a guide to effective qualification and validation based on Customer – Supplier Partnership”. The guide considers feedbacks from regulators, the pharmaceutical industry and suppliers as well as practical experiences from real project cases. In this updated 2.2 version there are new aspects of data integrity when working with electronic documents, new examples to make the process on “how-to-do” the critical aspects risk assessments (CARA) easier to understand, improvements on illustration of remote FAT/SAT, as well as some new aspects in equipment categorization and setting-up a contract between pharmaceutical customers and suppliers. It is the endeavor of the expert team to keep the guide always up to date with the latest knowledge through newly gained experiences.
The experts working on this guide will be present so participants will have the opportunity to hear first-hand and to discuss the contents and technical aspects of the guidance document, its scope and practical application. Case studies are presented to help better understand the content of the guide and its implementation. All delegates will receive the possibility to download the current guide free of charge . Case studies explain how to work together with suppliers and how to use an integrated approach.


Qualification of equipment and validation has been mandatory since the late 80s (FDA Guideline on Process Validation) and the early 90s (EU GMP Guide). Due to inspection results at that time, qualification activities increased significantly and very often, the focus on the patient was lost. The original purpose behind qualification, which is to show that equipment is fit for its intended use, was lost. A white paper from the ISPE “Risk-based qualification for the 21st century tried to amend this. With reference to this paper, ECA´s Validation Group has now further developed a Good Practice Guide on Modern Qualification to Integrated Qualification and Validation. This guide is supposed to assist pharmaceutical companies and suppliers with how to qualify equipment in a lean way and how to integrate the qualification into validation.  Like in the GAMP-Guide, examples build the core of this further developed Good Practice Guide on Integrated Qualification and Validation.


Everyone who may be influenced by the Annex 15 revision and FDA Process Validation Guidance regarding Qualification/Verification and Process Validation activities and want to see how an integrated approach to qualification and validation can enable successful, lean projects. So addressed are pharmaceutical companies, API and excipients manufacturer and of course equipment supplier and engineering companies.

ECA´s Integrated Qualification and Validation Guide

All delegates receive the latest Guide Version 2.2 with a lot of examples and templates.


Introduction to Integrated Qualification and Validation  
Ralf Gengenbach
  • Development of ECA´s Integration and Validation guideline until version 2.2
  • What is new?
Integrated Qualification and Validation acc. EU GMP Annex 15: Inspector´s View
Dr Rainer Gnibl
  • Qualification Life Cycle (Overview) 
  • Boundaries & Possibilities of Annex 15
  • What is a must, what is a nice to have?
  • Linking of  Qualification & Validation possible?
  • What GMP rules are important for contracting (overview)?
  • GMP rules for electronic documentation from supplier? (Overview)
  • How about equipment categorization to leverage qualification activities
ISPE Commissoning & Qualification Guide Version 2 (2019)
Jörg Zimmermann
  • ISPE Baseline guide 5 Update
  • Key Aspects/features of the ISPE Baseline
  • How do we do a GAP assessment of current practices vs the new BG-5?
  • Implementation program for BG-5 and sustaining operations
  • GAMP 5 2nd version
How suppliers work: Good Engineering Practice in Qualification
Ralf Gengenbach
  • Basic Engineering Workflows (CD, BD, DD – EPCMQ Projects)
  • Process-, Equipment Engineers and more (the full picture)
  • Key Documents in Engineering Processes
  • FAT, SAT and Commissioning
  • How a supplier can support qualification
  • Typical pitfalls?
Remote FAT/SAT
Rolf Bauer & Dr Clemens Borkenstein
  • Defintion, considerations and limits regarding remote testing
  • Collaboration and alignment of equipment manufacturer and customer
  • Checklist for preparations before / during and after a remote FAT
  • Documentation of results and handling of deviations
  • Show case project for remote test execution including “best of” video sequences
Equipment Categorisation – a tool to streamline qualification
Maik Guttzeit
  • Regulatory possibilities for using qualification approaches, which are adapted to relate risk
  • The revised categorization chapter, what is new?
  • New appendix: template equipment qualification
  • Examples
Case Study Customer supplier cooperation – A project example from Merck Healthcare KGaA
Holger Frey
  • Project description (Capex project with integrated Qualification Activities together with the supplier)
  • Project milestones
  • Qualification project together with the supplier
  • Validation and Start-up
Update Electronic Documentation in Qualification projects
Igor Krasula
  • Requirements for electronic documentation in qualification
  • Requirements related to Data Integrity
  • The ALCOA principle
  • Case study
3 C-Management
Axel Heueis
  • What does 3 C-Management mean?
  • When to start with GMP?
  • Ideal project course
  • GMP-Doc´s interfaces
  • Commissioning management slides
Overview about the Updates of the Working Groups 
Speaker to be announced
  • Contract group
  • CARA group
Feedback to the Integrated Qualification and Validation Guide  
Ralf Gengenbach
  • Open questions
  • Outlook
Tutorial Workshop 
Panel discussions about the way to electronic documentation in qualification Projects.


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