Ready for the future of GxP? According to new guidelines, NGS will replace PCR for evaluating viral content/clearance, vector integrity and integration events and effects on the host genome and transcriptome. It’s fast, sensitive and cost-efficient.
It’s easy to say that companies should use NGS to mitigate the risk of viral contamination, but in practice, it’s a little more difficult.
The ICH recently published Q5A(R2), which is a series of new guidelines on evaluating the viral safety of biotechnology products derived from cell lines.
Standards for computer systems validation (CSV) in the US and the EU are based on the practices created by the Organisation for Economic Co-operation and Development (OECD). For pharmaceutical GMP operations in the US, this is detailed in the FDA guidance 21 CFR Part 11:
It’s easy to keep up with regulatory changes like Q5A(R2) and 21 CFR Part 11 and continue delivering safe products to patients.
Execute your data analysis workflows across assays and instruments, on-premise or in the cloud, and easily achieve CSV compliance.
