Programme: ECA's new Integrated Qualification and Validation Guide

Introduction to Integrated Qualification and Validation

Gert Moelgaard, Head of ECA´s Validation Group

• Development of ECA's Integration and Validation guideline

Modern Qualification and Validation from an FDA perspective

Dr. Chris Watts, VoPal

• 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

Klaus Eichmüller, EU Inspector, Wolnzach c/o Regional Council Darmstadt

• 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

Gert Moelgaard, Head of ECA´s Validation Group

• 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

Peter Werner Christensen, Cook Medical

• 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

N.N., Jettconsortium

• Origins of JETT
• Adoption of GAMP Guidance
• Initial Work
• URS Development Method
• Workers vs. Clingons
• Works Produce

Equipment Categorisation - one way to efficient Qualification

Dr Clemens Borkenstein, ZETA

• 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

Ralf Gengenbach, Gempex

• 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

Rolf Bauer, Bosch

• 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

Dr Thomas Schneppe, Bayer Pharma

• 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: Transforming Novo Nordisk´s qualification and validation concept to focus on GEP and supplier collaboration

Peter Larsson, Novo Nordisk A/S

Feedback to the Integrated Qualification and Validation Guide

Gert Moelgaard, Head of ECA´s Validation Group

• Open questions
• Outlook