Best Practices in Analytical Method Development and Testing
About a decade ago, FDA and other regulatory agencies introduced a series of pharmaceutical guidance documents that included risk management and quality by design (QbD). These initiatives were aimed at modernizing the manufacturing of small-molecule drugs and biologics. The topics on risk management and QbD were published as International Council for Harmonization (ICH) guidance Q9 (1) and ICH guidance Q8 (2), respectively. Both concepts have been widely accepted by the industry within the manufacturing space and have been applied effectively to minimize production failure risks and define a design space where quality target product profiles can be managed and maintained.