This guideline describes science and risk-based approaches for developing and maintaining analytical procedures suitable for the assessment of the quality of drug substances and drug products. It applies to new or revised analytical procedures used for release and stability testing of commercial drug substances and products (chemical and biological/biotechnological). The guideline can also be applied to other analytical procedures used as part of the control strategy following a risk-based approach.

Keywords: development of analytical procedures, robustness, parameter ranges, analytical procedure control strategy, lifecycle management, multivariate analytical procedures, real time release testing