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´s new Commissioning and Qualification Guide
- What is ISPE?
- ISPE Guide Commissioning and Qualification from 2001
- New ISPE Guide Commissioning and Qualification, version 2 from 2019
- What is new?
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
Panel discussions with regulatory authority and pharmaceutical industry ensure the transfer from theory into practice.