Equipment Qualification Forum

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 leverage 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 25 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 qualification activities. Suppliers are an important factor in this modern approach. And therefore the ECA has developed a "Good Practice Guide Qualification and Validation - a guide to effective qualification based on Customer – Supplier Partnership”.

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. At a red thread the forum shows that based on knowledge management the risk assessments lead to URSes and further qualification activities. And then GEP interacts with the qualification activities. One lecture focuses on Artificial Intelligence and two cases studies show modern approaches like Lean VMP and Fleet Management. Especially for suppliers a “Pixi”-Booklet is developed from the group and will be presented.

Background

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 further developed their Good Practice Guide Qualification and Validation. This guide is supposed to assist pharmaceutical companies and suppliers with how to qualify equipment in a lean way.

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. Also addressed are pharmaceutical companies, API and excipients manufacturer and of course equipment suppliers and engineering companies.