Pharmaceuticals quality assurance

Abstract

Safe and effective medicines of high quality are required for treatment of diseases. Due to unfamiliar processes, unknown additives, adulteration and substitution without scientific proof, many tragic deaths have happened. Due to thalidomide case in Germany many birth defects and abnormalities have occurred. Due to diethylene glycol poisoning of sulfanilamide elixir, many children died. Similarly in India poisoning of gripe water with toxic preservative has caused many deaths. Hence prior proof of medicine is established by clinical trials. Quality control department plays important role for assuring safety and purity of Pharmaceutical products. Quality may be defined according to ISO as the totality of features and characteristics of a product or service that bear on its ability to satisfy stated or implied needs. Quality is the desire of the customer. Loss of quality means the loss of customer satisfaction, loss of public health and loss of the organization's resources. This is a prime business parameter and from time to time the concept and process of quality have changed depending on the prevailing market environment. Quality is an outcome of a quality culture in a business organization it cannot be achieved only by technical application. Quality culture means prevention and elimination of errors, waste, reworks etc.