Answer / anandpcp

validation :Action of proving and documenting that any
process, procedure or method actually leads to the
expected results

VP : The VP is a written plan stating how validation will be
conducted, including test parameters,
product characteristics, production equipment and decision
points on what constitutes
acceptable test results.

V M P :VMP is a high level document that establishes an
umbrella validation plan for the entire project
and summarizes the manufacturer’s overall philosophy and
approach, to be used for
establishing performance adequacy. It provides information
on the manufacturer’s validation
work programme and defines details of and time-scales for
the validation work to be
performed, including stating the responsibilities relating
to the plan.

If we get 100% assay of an Initial sample ,and the stability studies of the same sample got 90% dissolution result, and when the same stability sample was analyzed for RS studies no impurities was found . Where the 10% Active substance were gone during dissolution analysis.Please help me in getting the conclusion.

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