Final version: ECA's Integrated Qualification
and Validation Guide
Working with Suppliers towards modern Qualification and Validation
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 impromvent in the future
ISPE Commissoning & Qualification Guide Version 2 (2019)
- Why to change the Baseline vers 1
- Key Aspects of the ISPE Guide
- How do they relate to each other
Case Study: Water System
- Risk workshop
- DQ the central qualification element
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 priniciples 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, excecuted and documentated in electronic format
- Requirements for electronic documentation in qualification
Feedback to the Integrated Qualification and Validation Guide
- Open questions