In the pharmaceutical laboratory, deviations occur, sometimes frequently, and
with varying degrees of seriousness. Generally speaking, a deviation leads to noncompliance and, as such, requires careful tracking, monitoring, and remediation.
A deviation may take one of two forms: It may occur when instructions regarding
a specific activity, such as those laid out in the standard operating procedures
(SOP), batch record instructions, or other guidelines, are not carried out, are
delayed, or are performed incorrectly; or a deviation may also be defined as a
difference between normal and expected value in the pharmaceutical laboratory
process. In some cases of course, the two types of deviations may cross over if an
unexpected value is the result of a procedural error. It is those deviations and
errors – and the subsequent actions that must be taken to address them – that cause an already long development cycle to become even
longer. In the event of a public health crisis, time is of the essence, and measures must be taken to reduce the development cycle time
while maintaining quality.