A Research On Establishment Of Drug Quality Cost Management System In Liwah Pharmaceutical

With the implementation of 《Good Manufacturing Practice (2010 revision》) (hereinafter referred to as GMP) some pharmaceutical manufacturing enterprises were eliminated. In the remaining more than 4,000 pharmaceutical manufacturing enterprises they are facing common problems:small scale, low R&D capacity, high cost and poor risk resistance. Under market economy system, quality has become the core factor of market competition. But in order to improve the quality normally we have to pay higher cost for labor, material, technology and management.With the effect of national policy Chinese pharmaceutical manufacturing enterprises have entered a period of market competition with dual core of quality and price. How to realize the effective control of the quality cost under the premise of ensuring the quality of drugs, has become the key to win the competition in the market.Liwah Pharmaceutical was a former state-owned enterprise and after restructuring it becomes wholly foreign-owned enterprise. All of their seven dosage forms 68 products have been granted the new version of GMP certificates.Except for individual specialty drug products, Liwah Pharmaceutical’s products are low margin products. In order to obtain advantages in the current fierce price competition, it is necessary to strengthen the technological innovation ability and control cost more effectively meanwhile improving quality. And this requires enterprises to establish effective quality cost management system.This paper introduces theoretical basis and development of quality cost management, points out the necessity of the quality cost management of pharmaceutical production enterprises, and introduces the quality cost management of Liwah Pharmaceutical. According to the quality cost to conduct a comprehensive statistics and analysis system of Liwah Pharmaceutical from July 2014 to December. This paper finds out the main reasons for the existence of bad costs for business decision makers. Mainly based on the quality of the material existence of the problem and lead to the production process is not qualified product rate rise, the production process is not strictly followed by the operating procedures and lead to the increase of rework costs, so as to bring about the rise of the cost of quality.For Liwah Pharmaceutical problems this paper puts forward the improving solution:to establish parallel cost and quality audits of supplier management system; to establish parallel quality assessment and cost evaluation of production process management system; and then to establish a comprehensive quality cost management system, seeking for the best balance point between quality and cost, providing basis for business management.