Launch Conference
Final version: ECA's Integrated Qualification
and Validation Guide

Working with Suppliers towards modern Qualification and Validation

27/28 October 2020 in Berlin, Germany (on site) or broadcasted live to your desk!

Highlights:

  • Regulatory perspective from EU: view on Annex 15 and the integrated approach
  • Customer and Supplier Cooperation: Integrated Qualification
  • New ISPE Commissioning &Qualification guides: From version 1 (2001) to version 2 (2019) - and other related guides
  • Panel Discussion ECA´s Integrated Qualification Guide vs ISPE GEP Guide
  • Qualification terms (commissioning, verification…) – are Babylonian times back?
  • Equipment Categorisation – one way to an effective qualification
  • Qualification and Validation: An integrated approach  
  • 4 Case Studies
    - How to Benefit from the Supplier and Customer/User Collaboration when proofing Equipment´s Fitness for Use
    - Water Systems
    - Risk Managed Qualification in Capital Projects
    - Update Transforming Novo Nordisk´s qualification and validation concept to focus on GEP and supplier collaboration

Objectives:

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, so the overall qualification and validation effort is complicated, expensive and time consuming. Only few companies have leverage their qualification and validation programs to a fully integrated approach, as the EU Annex 15 and the FDA Process Validation guide enables.

Qualification is an activity with a history of more than 20 years, but it is still hotly debated. Even modern approaches, aimed at time and cost optimization, do not seem to bring about the expected improvement. A non-harmonized terminology emerges as one of the main problems, especially when it comes to the integration of good engineering practice. An attempt to create clarity here could be a signpost for a future optimized approach. This attempt will be made in the context of this conference.

The s Conference is also about time saving integrated qualification and validation activities. Suppliers are an important factor in this modern approach.

A team of pharmaceutical companies, engineering companies and  suppliers have further developed  ECA`s Good Practice Guide “Modern Qualification” from the last years feedbacks from regulators, the pharmaceutical industry and suppliers are now integrated to improve the document to more needs of the users.. The revised guide “Integrated Qualification and Validation – a guide to effective qualification based on Customer – Supplier Partnership!  will be presented in the final version.

The team behind the draft guideline will be present. Participants will have the opportunity to review and discuss the contents and technical aspects of the guidance document, its scope and practical application and to discuss. All delegates will receive a copy of the guide free of charge. Case studies explain how to work together with suppliers and how to use an integrated approach.

Background:

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.