Requirements for Quality or QA Oversight

The Guidance for Industry – Sterile Drug Products Produced by Aseptic Processing, the EU GMP Guide 1, as well as the new Annex 1, all require QA Oversight. Within the framework of a Contamination Control Strategy, as mandated by Annex 1, QA Oversight is another pillar to reduce the risk of product contamination.

But what exactly are the tasks of QA Oversight? How are these tasks conceptually implemented? Who bears the responsibility? How is QA Oversight inspected? What are the "soft skill" requirements for QA Oversight?

Since not every step in aseptic production can be technically controlled, a high level of trust in the involved staff is required. This is ensured, on the one hand, through good basic training, followed by so-called refreshers, and through open error communication, which guarantees good deviation management. It is the management's responsibility to convey to the personnel the awareness or consciousness of the significance of faulty production.

In this seminar, we will show you how to establish and maintain a professional QA Oversight concept in your company.