The updated ICH Q5A(R2) guidelines recommend next-generation sequencing (NGS) as the preferred approach for detecting adventitious agents. From cell line development and viral clearance studies to contamination tracing and product characterization, NGS-based tests outperform older assays in efficacy, sensitivity and reproducibility. This forms the basis for implementation by leading regulatory authorities, including the FDA, EMA, PMDA, and MFDS, signaling a global shift in biosafety testing.

Ensure easy compliance with these new directives by using a robust, computer systems validation (CSV)-friendly software platform that supports transparency and traceability throughout your biologics production pipeline.

You will learn

• - The impact of current guidelines, including ICH Q5A(R2), FDA 21 CFR Part 11 and European Pharmacopeia Chapter 2.6.41 on biologics production

• - Key requirements on data integrity, audit trails, user authentication and more, for setting up GMP environments

• - How QIAGEN CLC Genomics Workbench and Server support achieving GMP compliance