Thursday, October 29, 2015

Regulatory expectation and guidance on Pharmaceutical market complaints

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”.

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