Flexible equipment qualification requires less time and reduces costs

The qualification of equipment has been a regulatory requirement for many years. Although the revision of Annex 15 allows significantly more flexibility in equipment qualification today, it is often still very static and complex. To change this, the ECA published a draft of a Good Practice Guide on Modern Qualification last year. Feedback from authorities, pharmaceutical companies, engineering companies and suppliers to this draft is currently being incorporated. The revision will be presented as Integrated Qualification and Validation Guide - A guide to effective qualification based on Customer - Supplier Partnership at a Launch Conference in Berlin, Germany, on 8/9 October 2019. All participants get a copy of the new Guide. In addition to the presentation of the Guide you will find out in case studies what possible implementations can look like. And you will also get an assessment from an authority representative of the integration of qualification and validation described in the guide.

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