Modern Qualification & Validation
Im Auftrag der ECA Academy

Programm

Introducing the ECA Guideline: Modern Qualification - A guide to cost effective qualification based on Customer - Supplier Partnership

• Development of ECA´s Modern Qualification guideline
• Content of the guideline
• Application of the guide by suppliers and users
• Fit into the GMP regulations
• Benefit for involved parties
• Outlook

Modern 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?

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?

Supplier Guidelines: The history of the GAMP Guide and its impact

• The need for guidance – objectives and drivers
• The Long and Winding Road
• Lessons learnt, and what the future holds…

Overview of current industry guidelines on Qualification and Validation

• ISPE Guides on C&Q, risk-based qualification and process validation
• GAMP® 5 guide on Computerised Systems
• PDA guides on process validation
• ECA guide on process validation

Qualification and Validation: An integrated approach

• PQ 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)

The role of the User Requirement Specification (URS) for successful pharmaceutical equipment projects

• Requirements for a successful URS
• The process from URS to approved design documents
• Important players during creation of URS and design documents
• Case study Octapharma Vienna

Good Engineering Practice – leverage the quality system of a good pharma equipment supplier

• What is GEP?
• GEP guidelines
• Commissioning vs Qualification
• GEP in the GMP environment

Case Study: Science and risk-based Commissioning and Qualification – J&J Pharmaceutical Plant in Xiang

• Project Overview – risk-based approach
• PPURS and URS
• Risk assessment
• Test matrices
• Commissioning
• Outcomes in numbers

Case Study: Verification approach as enabler of Fast track execution

• Risk-based approach
• Risk assessment defined for module
• Modularisation/bigger packages – less suppliers to audit
• No IQ/OQ performed – switch directly from SAT to PQ after verification

Case Study: Fast track project executions

• Presentation of outline data and boundary conditions for fast track projects
• Important milestones in the project
• Objective for fast track project and determinations
• Success factors and challenges in the project

Workshops
Two tutorial workshops about “What should be in an URS to ensure a successful project?” and “Quality Risk Assessment and Critical Aspects” ensure the transfer from theory into practice.