Departure from an approved instruction or established
standard. • Deviation is a departure from approved procedure or established
standard or specification
Any deviation from established procedures should be
documented and explained. Deviations in yield associated with critical process
steps should be investigated to determine their impact or potential impact on
the resulting quality of affected batches. • Any deviations from this should be
evaluated to ensure that there are no detrimental effects upon the fitness for
purpose of the material.
A deviation is an activity performed differently and/or
modified than that specified in an approved document. There are two types of
deviations
Planned deviations, which are described, and per-approved deviation from
the current operational document/system, covering a specified period of time or
number of batches. • Planned deviation shall be approved before execution •
Planned deviations should be handled through the QA approved change control
procedures. • All changes should be evaluated for product impact, significance
– The need for re-qualification or re-validation – Changes ultimately approved or
rejected by QA. • QA should insist that planned deviations not be used; all
deviations should be unintentional, unplanned, or unexpected
Ex. Change in process during manufacturing, change in master of any
product related raw material and packing
material, etc.
Unplanned deviations also called as incident. • Incident can be defined
as unplanned or uncontrolled event in the form of non- compliance from the
designed systems or procedures at any stage of manufacturing, packaging,
testing, holding and storage of drug product due to system.
Ex. Unexpected Electric cut during manufacturing, machine breakage during
process
CLASSIFICATION
Those deviations which doesn’t affect
the quality of product are categorized as non critical deviations.
Ex. Documentation was not
proper
Those deviations which affect the quality and appearance of product are categorized
as an critical deviation.
Ex. Deviation of failer of procedure, incorrect charging of material,
wrong pack size, wrong parameters.
