Quality Oversight for Virtual Companies - Live Online Training

Hear and discuss the expectations and best practices for effective and efficient Quality Oversight processes and how to get there. This will support you turning your company’s quality excellence goals into reality.

Some Marketing Authorisation Holders but also innovative start-ups and Research & Development organisations outsource most, if not all, manufacturing, testing and distribution activities of their product(s) and are virtualizing their business. Quality Oversight in such a Virtual Company is challenging, but essential to ensure that products are safe, effective and of the correct quality.

There are some good reasons for such an approach. It gives smaller organisations the opportunity to bring their own product(s) to the market and keep the focus on research and development and it also helps attracting investors. The actual employees can concentrate on core competencies. For larger companies, it offers more flexibility and a good way to quickly add new products to the portfolio and develop markets faster.

Of course, such a business model also brings some challenges. One needs a high degree of trust with the business partners in the supply chain, must be able to deal with differences in corporate and quality culture and, above all, have the necessary oversight of the quality and supply chain of all activities and products.
Just as it is with other business areas, management has the responsibility to ensure that systems are in place to effectively monitor the state of control in order to intervene with timely decisions to manage risk, achieve goals, and add stakeholder value. It is of utmost importance to detect and heed possible problems early enough.

In 2021 EMA has published a reflection paper entitled "Good Manufacturing Practice and the Marketing Authorisation Holder", which was slightly updated 2022. The goal was to provide clarity on the different responsibilities and their practical significance for MAHs. Ultimately, the aim was to summarise and, if necessary, explain in one document the responsibilities that are described in various places in the relevant GMP documents such as the EU-GMP Guidelines or the respective Directives.

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