Qualification and Validation Forum 2023

Objectives

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 to prevent changing all procedures already set. Still many companies have very little integration between their activities, so the overall qualification and validation effort is complicated, expensive and time consuming. But some companies have leveraged their qualification and validation programs to a fully integrated approach, as the EU Annex 15 and the FDA Process Validation guide enables.

Qualification is an activity with a history of more than 20 years, but it is still hotly debated. Even modern approaches, aimed at time and cost optimization, do not seem to bring about the expected improvement. A non-harmonized terminology emerges as one of the main problems, especially when it comes to the integration of good engineering practice/commissioning activities with qualification activities. An attempt to create clarity here could be a signpost for a future optimized approach. This attempt will be made in the context of this forum.

The Forum is also about time saving integrated qualification and validation activities. Suppliers are an important factor in this modern approach.

A team of pharmaceutical companies, engineering companies and suppliers is currently developing further the version 2.2 of ECA`s Good Practice Guide “Integrated Qualification and Validation – a guide to effective qualification based on Customer – Supplier Partnership” to a bigger revision. Under discussion are again feedbacks from regulators, the pharmaceutical industry and suppliers to improve the version 2.2 from last year to more needs of the users. New aspects are introduced to Critical Aspects Risk Assessments (CARA) and about Equipment Categorization. Also, revisions in the in the main text are discussed.

The speakers are team members or reviewers of the guide So you have the opportunity to discuss the contents, technical aspects of the guidance document, its scope and practical application during Q&A sessions and a survey. All delegates will receive a copy of the current version free of charge as download. Case studies explain how to work together with suppliers and how to use an integrated approach.

Background

Qualification of equipment and validation 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 further developed their Good Practice Guide on Integrated Qualification and Validation. This guide is supposed to assist pharmaceutical companies and suppliers with how to qualify equipment in a lean way and how to integrate the qualification into validation. Like in the GAMP-Guide, examples build the core of this further developed Good Practice Guide on Integrated Qualification and Validation.

Target Audience

Everyone who may be influenced by the Annex 15 revision and FDA Process Validation Guidance regarding Qualification/Verification and Process Validation activities and want to see how an integrated approach to qualification and validation can enable successful, lean projects.