TOTAL QUALITY MANAGEMENT IN PHARMACEUTICAL

Quality assurance policy had become the most important goal of pharmaceutical industry. The concept of quality assurance and quality control develops and follows standard operating procedures are directed towards assuring the quality, safety and efficacy. World Health Organization has issued a primary or fundamental regulation to pharmaceutical industries entitled good manufacturing practice (GMP) for pharmaceuticals.

Thus, quality is critically important ingredient to organizational success today which can be achieved by total quality management (TQM) in an organization wide approach that focuses on quality as an over arching goal. The basis of this approach is the organizational units should be working harmoniously to satisfy the customer. Since the customer’s needs are in constant flux, the organization must strive to continuously improve its system and practices. The TQM perspective views quality as the central purpose of the organization, in contrast to the focus on efficiency advocated by the operational perspective.

Quality is a very commonly used term but can be described very vague. Quality is an unusually concept, easy to visualize and difficult to define. It is a matter of feeling and the definition varies from person to person depending on the perspective in which defined. Quality has been defined in different ways by the quality gurus as – conformance to standards or specifications; fitness for use; meeting customer requirements or expectations; delighting the customer or more. The code defines as ‘quality therefore is the totality of features and characteristics of a product/service that bears on its ability to satisfy given needs.

If we are selecting a tablet for buy, we shall compare the different brands of that particular tablet on the basis of their efficacy and side-effects, colors and odors’. Thus a customer/user of a product makes a comparison of features or attributes of the product and also the absence of deficiency in it, while comparing the quality.

The control decisions should be independent, and they must not yield to or be overruled by, production or marketing under any circumstances. Because the control decision can involve the health of the consumer and the reputation of the pharmaceutical manufacturer, the climate necessary for making judicious decisions is essential. In times of major disagreements, the control decision should be subjected to review only at the highest level of management.