Analytical Procedures and Methods Validation for Drugs and Biologics – Guidance for Industry – PDF free Download


U.S. Department of Health and Human Services
Food and Drug Administration
Center for Drug Evaluation and Research (CDER)
Center for Biologics Evaluation and Research (CBER)

An analytical procedure is developed to test a defined characteristic of the drug substance or
drug product against established acceptance criteria for that characteristic. Early in the
development of a new analytical procedure, the choice of analytical instrumentation and
methodology should be selected based on the intended purpose and scope of the analytical
method. Parameters that may be evaluated during method development are specificity, linearity,
limits of detection (LOD) and limits of quantitation (LOQ), range, accuracy, and precision.

During early stages of method development, the robustness of methods should be evaluated
because this characteristic can help you decide which method you will submit for approval.
Analytical procedures in the early stages of development are initially developed based on a
combination of mechanistic understanding of the basic methodology and prior experience.
Experimental data from early procedures can be used to guide further development. You should
submit development data within the method validation section if they support the validation of
the method.

To fully understand the effect of changes in method parameters on an analytical procedure, you
should adopt a systematic approach for a method robustness study (e.g., a design of experiments
with method parameters). You should begin with an initial risk assessment and follow with
multivariate experiments. Such approaches allow you to understand factorial parameter effects
on method performance. Evaluation of a method’s performance may include analyses of
samples obtained from various stages of the manufacturing process from in-process to the
finished product. Knowledge gained during these studies on the sources of method variation can
help you assess the method performance.

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