The regulations with regard to Qualification and Validation are very different in the US, in Europe in China and other countries. The core thinking is similar, though.
What these activities have in common is that they cost a lot of time and money. In many companies, pharmaceutical projects entail internal requirements - including numerous activities and documents. However, many of these are unnecessary - and possibly delay projects.
What's more, with the increasing globalisation equipment qualification also becomes global. Equipment, for instance, is purchased from suppliers around the world. However, sometimes they don't know the local or the specific customer requirements. And these customer requirements are very different, although the regulations are similar or even the same. Some of the big questions to be answered are:
A new and unique Guideline now integrates Qualification and Validation activities - as it focuses on how to work with suppliers in cost-effective projects. This new ECA Good Practice Guide to Integrated Qualification and Validation was developed by a team of pharma, supplier and engineering companies.
Many companies "qualify everything" to satisfy regulators, and qualification tests are repeated again and again during the qualification tests. The partners working together on the new Guide therefore shared templates, examples and best practices for many typical project documents: User Requirements Specifications (URS), Requirement Traceability Matrix (RTM), Design Qualification (DQ), Test Matrix (TM), Critical Aspects Risk Assessment (CARA) and others. These templates are useful tools for a science- and risk-based approach to qualification and validation.
In summary this means: In the global world of pharmaceuticals, global standards are needed to meet local requirements. The Integrated Qualification and Validation Guide thus is a guide to effective qualification based on a customer-supplier partnership, providing hands-on templates to help customers and suppliers work together towards a "lean qualification" in an integrated way.
The guide will be launched at ECA´s Launch Conforence ECA´s Integrated Qualification and Validation Guide in Berlin, Germany, from 8-9 October 2019, where you will also have the opportunity to get an EU inspector's view as well as practical experience examples from several companies, including Bayer, Novo Nordisk.
PS. Special service for participants at the launch conference: get your free download of Jettconsortium templates (URSes for steam generator, bioreactor, blender etc., risk assessments, SDS, FS)