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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. 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 successfully integrated their qualification and validation programs, as the EU Annex 15 and the FDA Process Validation guide enables.
This Modern Qualification and Validation conference is about cost-effective and time saving integrated qualification and validation. Suppliers of equipment, facilities, engineering etc. can are an important factor in this.
A team of pharmaceutical companies and suppliers have developed a new ECA Good Practice Guide: “Modern Qualification – A guide to cost effective qualification based on Customer - Supplier Partnership”. The first public draft of this guide will be presented.
The team behind the draft guideline will be present and there will be participants from regulatory authorities from EU and USA. 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. Three case studies regarding fast track qualification projects and inspector´s expectations on such projects will also be presented.
Qualification of equipment 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 developed a Good Practice Guide on Modern Qualification – A guide to cost effective qualification based on Customer - Supplier Partnership. This guide is supposed to assist pharmaceutical companies and suppliers with how to qualify in fast track projects. Like in the GAMP Guide practical documentation, examples build the core of this Good Practice Guide
Everyone who may be influenced by the Annex 15 revision and FDA Process Validation Guidance regarding Qualification/Verification and Process Validation acitivities and want to see how an integrated approach to qualification and validation can enable successful fast-track.
Introducing the ECA Guideline: Modern Qualification - A guide to cost effective qualification based on Customer - Supplier Partnership