Integrity Assurance for Single-Use Ststems: End-User Perspective - ERP Spain.com - España y América Latina

Single-use technologies are more and more used in critical sterile applications, e.g. close to final manufacturing steps handling Drug Product, leading to increasing concern related to integrity. In this presentation, we make a review of the regulatory environment and present key elements to consider to defined and apply a sound integrity control strategy. The regulatory environment has significantly evolved in last years, with the publication of new guidance and standards and additional ones in preparation.  Current draft of EU GMP Annex 1 illustrates the increased scrutiny of regulatory authorities on this topic.   We will position integrity tests in the more global picture around integrity strategy. Concepts such as QbD and QRM, as well as close collaboration between supplier and end-user are required to build a good strategy and enhance the integrity assurance for processes using single-use systems. A defined integrity control strategy is very important for critical applications where single use systems are used after last sterile filtration step or in a process where no sterile filtration is possible. We will discuss the different technologies available on the market to control integrity of single-use systems and key parameters that are affecting integrity measurements, at supplier’s and at end-user’s side. Several case studies will be shared, illustrating how integrity concerns can be practically addressed for cGMP manufacturing applications, and what are the results observed after a few years of use.