GMP Sequencing: Ensuring Quality, Compliance, and Accuracy in Regulated Genomic Testing
GMP sequencing has become a critical component in regulated genomics, especially for industries such as pharmaceuticals, biotechnology, clinical diagnostics, and cell and gene therapy. As sequencing technologies continue to influence drug development and personalized medicine, adherence to Good Manufacturing Practice (GMP) sequencing standards ensures data integrity, regulatory compliance, and patient safety. What Is GMP Sequencing? GMP sequencing refers to next-generation sequencing (NGS) or other genomic sequencing workflows performed under Good Manufacturing Practice (GMP) guidelines. These guidelines are enforced by regulatory authorities such as the FDA and EMA to ensure consistent quality, traceability, and reproducibility in processes that impact human health. Unlike research-use-only sequencing, GMP-compliant sequencing follows validated protocols, controlled environments, and strict documentation practices. This makes it suitable for regulated applications, including clini...