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ECA - Integrated Qualification with Suppliers

 

Integrated Qualification with Suppliers (15 September 2020)

Objective

A new ECA guideline on Integrated Qualification and Validation enables pharmaceutical companies and suppliers of pharmaceutical equipment and systems to cooperate more cost-effective than the traditional pharmaceutical approach to qualification. The guide is developed by a pharmaceutical companies and suppliers based on practical experience and document examples from many international commissioning and qualification projects.

The conference will give pharmaceutical professionals and suppliers of equipment, systems and engineering to the pharmaceutical industry will get an overview of the “Integrated Qualification & Validation” approach and the templates and examples for use in projects in the future. The conference includes experiences from both pharmaceutical customer, suppliers and engineering & consulting companies 

  • Cost-effective project cooperation models and templates
  • Critical Aspects of manufacturing systems
  • Good Engineering Practice and its influence to leverage qualification activities
  • Cost-effective cooperation between suppliers and their pharmaceutical customers

Background

For pharmaceutical companies and suppliers to the pharmaceutical industry a good partnership on Testing, Qualification and Validation is increasingly important.

Project time and cost can be saved if the pharmaceutical requirements on Good Engineering Practices, Qualification and Validation are well known. Therefore ECA has developed a Good Practice Guide for “Integrated Qualification & Validation” - a guide to effective qualification based on Customer-Supplier partnership.

The guide has been developed in partnership between pharmaceutical companies and suppliers of equipment, systems and engineering to the pharmaceutical industry. The first draft was made public at a conference in Berlin in September 2018 with participation from both European regulators and US FDA.

Qualification and validation have been mandatory activities for many years in the pharmaceutical industry. But new international regulations based on quality risk management principles can enable a better and more cost-effective approach to design, testing and documentation of supplier activities - in partnership with pharmaceutical customers.

Additional Benefit

You will get a free copy of ECA Good Practice Guide: “Integrated Qualification and Validation – A guide to cost effective qualification based on Customer--Supplier Partnership.

Moderator

Gert Moelgaard, ECA Validation Interest Group

Target Audience

Managers from the pharmaceutical industry and especially their suppliers of pharmaceutical equipment and services 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 fast-track projects

 

Programme

CONGRESS KEYNOTE

Annex 1 Revision – the long and winding road
Dr. Bernd Renger, Immediate Past Chair, European Qualified Person Association

  • The drivers of change
  • New paradigms and concepts
  • Contamination Control und Quality Risk Management
  • Stakeholder consultation
  • New expectations to Media Fills and Lyophilisation
  • The big challenges – CCIT and PUPSIT

 

Future qualification and validation involves suppliers
Gert Moelgaard, Chairman, ECA Validation Group

Pharmaceutical facility projects can save significant time and cost with good cooperation between customers and suppliers. Examples from USA, Europe and China demonstrates that there is a lot to win, compared with what most companies does today. ECA’s new Good Practice Guide on Integrated Qualification and Validation is a useful tool that yous should consider.

GEP for Suppliers – A Prerequisite for Fast Track Qualification projects?
Ralf Gengenbach, Gempex

Good Engineering Practice (GEP) is an important part of succesful qualification projects today and even more in the future. Suppliers of pharmaceutical equipment and systems need to understand the GEP principles, guidelines and requirements to ensure cost-effective and GMP compliant qualification projects.

Customer-Supplier Cooperation: A project example from Merck Healthcare KGaA
Holger Frey, Merck

Merck has good experience of cooperation with suppliers on the commissioning and qualification in recent projects. The success formula builds on building a close cooperation with the suppliers in a pharmaceutical project and the learnings from this can be an inspiration for other companies.

An effort to build smarter: Transforming Novo Nordisk ´s qualification and validation concept to focus on GEP and supplier collaboration
Peter Larsson, Novo Nordisk

Novo Nordisk has recently implemented a new global approach to qualification and validation based on quality risk management principles including focus on GEP and supplier collaboration. The presentation will outline the change and share experience from the transformation, especially regarding the cooperation with suppliers on qualification activities.

Using ECA’s Modern Qualification Guide as a pharmaceutical customer
Eva-Maria Baumgartner, Syntacoll

Syntacoll has developed a cost-effective approach to qualification and validation together with their suppliers. They are using a cost-effective approach based on categories of equipment which is a benefit during qualification. The presentation will share the customer perspective on expectation from their suppliers and an integrated approach to qualification and validation.

Panel Discussion