On way to manufacturing process
end number of steps, tests, check, audits and evaluation is there combined with
other quality system elements such as qualification validation and many more.
All these impart confidence that the system or process is functioning as
intended and assurance of safety, identity strength and quality. The last
hurdle is that the product must successfully marketed: to the consumer or
healthcare provider.
Still consumer complaints are
unavoidable circumstances. It may range from “don’t smell right” to “insect
parts are there inside the bottle during packaging” and the list can continue
for pages and pages.
Complaints are generally thought
of as communications concerning a real or perceived defect in the product or
that the product fails to meet the expectations of the consumer. US FDA defines
as “all scientific and data gathering activities relating to the detection,
assessment, and understanding of adverse events”.
