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

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

Course No 17540

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Speakers

Eva Baumgartner, Syntacoll
Dr Clemens Borkenstein, ZETA 
Franco Casinelli, Johnson and Johnson
Dr Berthold Düthorn, Syntegon
Ralf Gengenbach, gempex
Dr Rainer Gnibl, GMP Inspector
Peter Larsson, Novo Nordisk A/S
Gert Moelgaard, Moelgaard Consulting, Head of ECA's Validation Group
Alice Redmond, Commissioning Agents
Thomas Rücker, Letzner

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 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.

Target Group

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.

Panel Discussions

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

Programme

Introduction to Integrated Qualification  and Validation   
  • Development of ECA's Integration and Validation guideline
Integrated Qualification and Validation acc. EU GMP Annex 15: Inspector´s View
  • Qualification Life Cycle (Overview) 
  • Boundaries & Possibilities of Annex 15
  • What is a must, what is a nice to have?
  • Linking of  Qualification & Validation possible?
A Qualification Case using elements of the new ECA´s Good Practice
  • Content of the guideline
  • About necessary activities and explanations/interpretations
  • How to establish the basis for understanding of involved parties
  • The success and the areas for improvement in the future
ISPE Commissioning & Qualification Guide Version 2 (2019)
  • 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
Case Study: Water System
  • Risk workshop
  • DQ the central qualification element
  • GEP
  • ECA-Guideline
Equipment Categorisation – one way to streamline  Qualification
  • Equipment categorization helps to select an appropriate effort for qualification activities and helps to avoid excess work
  • What is the perfect timing for equipment categorization?  during design phase in a customer supplier partnership
  • Categorisation of Manufacturing Systems
  • Questionnaire for a categorisation
Qualification terms – are Babylonian times back?
  • What activities are required in qualification?
  • What are the terms used for it (EU, US)?
  • How are the different terms (FAT, SAT, Testing, Qualification, Verification) related?
  • How to solve the problem in daily projects?
  • The framework: Good Documentation Practice /Good Engineering Practice
Case Study: Risk Managed Qualification in Capital Projects
  • Why does capital project delivery need to change
  • What are the key principles of a project delivery
  • How risk managed qualification is embedded in the Capital projects and what are the steps and relevant content (from requirement to release)
  • How supplier can create value 
Qualification and Validation: An integrated approach
  • Process Qualification -  the „marriage“ of qualification and process validation
  • Development as basis
  • Integration of  critical process parameters into qualification
  • The real goal is Process Validation/PPQ
  • Key performance indicators
Case Study: Update – Transforming Novo Nordisk´s qualification and validation concept to focus on GEP and supplier collaboration
  • The transition from traditional qualification to a science-and risk-based integrated CQV process
  • What is good quality in qualification and validation
  • Core principles of Novo Nordisk
  • Tailor-made project execution based on risk
Electronic Documentation in Qualification projects – first ideas  
  • Scanned classical paper qualification documentation vs. tests being prepared, executed and documented in electronic format
  • Requirements for electronic documentation in qualification
Feedback to the Integrated Qualification and Validation Guide  
  • Open questions
  • Outlook

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