Next-generation sequencing (NGS) is an integrated tool for achieving GxP compliance for biosafety. With fast, sensitive, cost-efficient genetic sequencing, it can help evaluate vector integrity and integration, viral clearance, and effects on the host genome and transcriptome.  

Regulatory bodies now recommend using NGS to mitigate the risk of viral contamination. Biotechnology companies are adopting NGS testing and modernizing their electronic records to remain competitive and match these new regulations.  

New standards for manufacturing

Thanks to its versatility, speed and sensitivity, NGS is replacing older PCR tests as the standard for monitoring the safety of manufactured biotechnology products ¹. To ensure product quality and safety, regulatory authorities have developed new GxP guidelines for NGS-based assays, computer systems and analyses.  

The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) recently published Q5A(R2), on evaluating the viral safety of cell-derived products ². These guidelines suggest replacing older standards such as cell-based assays and other in vivo and in vitro tests with NGS approaches because of its increased sensitivity and accuracy.  

Standards for computer system validation (CSV) 

Biopharma companies need to validate diverse NGS assays derived from different methods, instruments, protocols and facilities, with minimal operational disruption. And that’s not everything. Another critical aspect of GxP compliance is maintaining quality and documenting it with auditable electronic records through computer system validation (CSV) processes.  

Regulations under both the US and the EU are based on guidelines from the Organisation for Economic Co-operation and Development (OECD) ³, which emphasize the need for validated computer systems that limit access to authorized users. The system should generate time-stamped audit trails to record date and time of actions which create, modify or delete electronic records. In the United States, this guidance was established by the Food and Drug Administration (FDA) in 21 CFR Part 11 ⁴. Any system needs to store existing NGS results and incorporate new data types as necessary.  

Simple GxP compliance for NGS data

With the right tools, you can achieve compliance with regulations like Q5A(R2) and 21 CFR Part 11, ensuring patient safety and product integrity every step of the way.  

QIAGEN CLC Genomics Server is a flexible platform for NGS data analysis workflows across assays and instruments, on-premise or in the cloud. Easily achieve compliance for your diverse data, computer systems and more. 

• Audit and validate: Generate, monitor, download and retain secure timestamped audit trails. Maintain data integrity and history/provenance for all your files and restrict data deletion according to your policies.
• Customize: Maintain full control over your operational system checks for GxP workflow activities, lock down optimized computational workflows and automate workflow execution.
• Secure and protect: Control access with authority checks, roles, and permission groups. Implement input checks, data integrity checks, file provenance, and nonrepudiation controls.

Join the ranks of biopharma companies transforming GxP compliance with QIAGEN CLC Genomics Server. Streamline your workflows, preserve data integrity and stay ahead of evolving regulations. 

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¹Ng SH, et al. Current Perspectives on High-Throughput Sequencing (HTS) for Adventitious Virus Detection: Upstream Sample Processing and Library Preparation. Viruses. 2018;10(10):566. doi: 10.3390/v10100566. PMID: 30332784; PMCID: PMC6213814.

²International Council for Harmonisation (ICH), European Medicines Agency (EMA). Viral Safety Evaluation Of Biotechnology Products Derived from Cell Lines of Human or Animal Origin Q5A(R2). (2023).

³World Health Organization (WHO). Annex 3: Good manufacturing practices: guidelines on validation. (2019).

⁴United States Food and Drug Administration (FDA). Part 11, Electronic Records; Electronic Signatures - Scope and Application. (2003).