Background and objective(s): An analytical procedure must be shown to be fit for its intended purpose. It is useful to consider the entire lifecycle of an analytical procedure when approaching development of the procedure, . its design, development, qualification, and continued verification. The current concepts of validation, verification, and transfer of procedures address portions of the lifecycle but do not consider them holistically. This General Chapter intends to more fully address the entire procedure lifecycle and define concepts which may be useful. This approach is consistent with the concepts of Quality by Design (QbD) as described in ICH Q8 (R2), 9, 10, and 11.
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A distribution is described as normal if there is a high probability that any observation
form the population sample will have a value that is close to the mean, and a low
probability of having a value that is far from the mean. The normal distribution curve
is used by many VaR models, which assume that asset returns follow a normal
pattern. A VaR model uses the normal curve to estimate the losses that an institution
may suffer over a given time period. Normal distribution tables show the probability
of a particular observation moving a certain distance from the mean.