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Biopharma Compliance

Biopharma Compliance

Understand the Interactions Between Critical Variables

Good manufacturing practices (GMP) for quality control testing include detailed information about the composition of raw materials, vitamins, media analysis, metal cations, and process- and product-related impurities. For quality control of biopharmaceuticals, you’ll need a comprehensive characterization profile to establish specifications and acceptance criteria. Let us help you implement Quality by Design (QbD) practices that build quality criteria into every step of the manufacturing process. We can also guide you through the related Design of Experiments (DOE) approach, so you can benefit from statistical multivariate analysis and modeling. Both techniques will help you gain a better understanding the interactions between critical method variables. Agilent provides a comprehensive portfolio of solutions for biopharma manufacturing and quality control. The portfolio includes liquid chromatography, mass spectrometry, spectroscopy, columns, consumables, and software to support manufacturing, compliance, and QbD.