Launch Conference: ECA's new Integrated Qualification and Validation Guide

Launch Conference: ECA's new Integrated Qualification and Validation Guide

Berlin, Germany

Course No 17270

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Tel.: +49 (0)6221 / 84 44 0 E-Mail: info@gmp-compliance.org

Speakers

Rolf Bauer, Robert  Bosch
Dr Clemens Borkenstein, ZETA 
Peter Werner Christensen, Cook Medical
Klaus Eichmüller, EU Inspector
Ralf Gengenbach, gempex
Peter Larsson, Novo Nordisk A/S
Gert Moelgaard, Moelgaard Consulting, Head of ECA's Validation Group
Dr Thomas Schneppe, Bayer Bitterfeld GmbH
Dr Christopher Watts, VoPal

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.

This Qualification conference is 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  last year.  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.

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 and with JETT Consortium  practical documentation, 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.

ECA´s Integrated Qualification and Validation Guide

All delegates receive ECA´s Integrated Qualification and Validation Guide– A guide to effective qualification based on Customer - Supplier
Partnership with a lot of templates.

Programme

Introduction to Integrated Qualification  and Validation   
  •  Development of ECA's Integration and Validation guideline
Modern Qualification and Validation from an FDA perspective
  •  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?
Qualification and Validation requirements from a European inspector´s view: Possibilities to integrate Qualification and Process Validation Activities
  •  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?
Introduction the ECA Guideline: Integrated  Qualification  and Validation - A guide to effective qualification based on Customer - Supplier Partnership  
  •  Content of the guideline
  •  Application of the guide by suppliers and users
  •  Fit into the GMP regulations
  •  Benefit for involved parties
ISPE Commissioning &Qualification guides: From version 1 (2001) to version 2 (2019) - and other related guides
  • 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
JETT Consortium – how to deal with example forms
  •  Origins of JETT
  •  Adoption of GAMP Guidance
  •  Initial Work
  •  URS Development Method
  •  Workers vs. Clingons
  •  Works Produce
Equipment Categorisation - one way to efficient Qualification
  • 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
Good Engineering Practice – A key to leverage the quality system of a good pharma equipment supplier
  •  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?
Case Study: Current Factory Acceptance Test (FAT) – market approaches between tradition and state-of-the-art
  •  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
Qualification and Validation: An integrated approach
  •  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)
Case Study: Hybrid Risk-based approach qualification – how to integrate a new qualification approach in an already existing Quality System
  •  Project Overview – risk-based approach
  •  Lessons learnt?
Feedback to the Integrated Qualification and Validation Guide  
  • Open questions
  • Outlook
Panel Discussions
Panel discussions with regulatory authority and pharmaceutical industry  ensure the transfer from theory into practice.

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