Although the topic of qualification has a long history and many updates and improvements have been made since it was first published, most pharmaceutical companies are still using an old and complicated approach to equipment qualification. They are not taking advantage of the opportunities offered by EU GMP Annex 15 and FDA guidance, which allow an "alternative" for a science- and risk-based approach, as well as leveraging the resources and expertise of their suppliers. Pharmaceutical company suppliers see the vast differences between their customers and can offer a very effective partnership to improve this situation.
The ECA guide "Integrated Qualification and Validation - a guide to effective qualification and validation based on Customer - Supplier Partnership" has addressed this issue and provides guidance to get the most out of this partnership. The guide is aligned with the ISPE Commissioning and Qualification Guide Revision 2 and also takes into account EU and US regulations and standard recommendations as those in ASTM E2500. The guide focuses on an ideal customer-supplier relationship and has now been updated to include more practical examples.
The new version 2.2. will be presented at ECA's Qualification and Validation Forum on 15/16 November 2022 in Heidelberg, Germany. In addition to other issues, this this new version now comprises new aspects of data integrity when working with electronic documents, improvements in the presentation of remote FAT/SAT, case studies, and new aspects in device categorization as well as the design of contracts between pharmaceutical customers and suppliers. It also provides a great benefit due to the many examples and templates in the appendices.