The quality control of non-sterile products

Abstract

Quality of pharmaceutical products is the sum of all the factors which contribute directly or indirectly to the safety, effectiveness and acceptability of the product. Quality to the patient is fitness for use. Confidence is important not only for the patient himself but also for all the members of the health profession. Quality affects also the manufacturer's costs. If there were no defects in the product, quality costs would disappear. However since we are human beings defects do unfortunately exist and costs include:- a) the preparation and conduction of programs for reaching and improving good quality, b) selection and control of ingredients and final product including packing and labelling, c) maintenance of equipment, d) consumption of products in the destructive tests, e) testing of products in field storage or in stock to evaluate degradation, f) keeping detailed records of all stages of manufacture.