How Equipment Suppliers can assist their Customers with Equipment Qualification

Equipment qualification is a mandatory requirement in the GMP area. So medicinal products/drugs and APIs are affected. In the past manufacturers of medicinal products/drugs and APIs did all qualification activities on their own. But more and more, equipment suppliers are being integrated into their customers' qualification systems. And equipment suppliers' qualification documentation is also accepted to support equipment qualification of their customers. Even Annex 15 of the EU GMP Guide mentions this.

These (integrated) activities are going in the right direction to get to a lean qualification. To be successful, however, a close relationship between supplier and customer is needed. Further, a project plan is essential to make these activities a success. With this project plan, tasks and reponsibilities are clarified in a documented way.

Mid of November the ECA has published the new version 2.2 of their Good Practice Guide "Qualification and Validation - A guide to effective qualification based on Customer Supplier Partnership". The guide is divided in four parts. Part 1 describes the activities of suppliers during equipment qualification, part two the customer's tasks. Part three explains how supplier and customer work together. Part four comprises 12 appendices with practical examples. There you will also find, among others, a Project Quality Plan example. 

The guide is offered for a free download on ECA´s Validation Group Website.

ECA's half-day Lean Equipment Qualification online training on 13 December from 13 to 17 h (CET) will explain how this relationship between supplier and customer can be implemented in 'real life', using two case studies.