Study On The Construction Of Quality System For One API Manufacturer

With the promotion and implementation of GMP (Good Manufacturing Practice for Drugs) in API (Active Pharmaceutical Ingredient) enterprises, the establishment of a standard quality system becomes more and more important. Particularly, since the implementation of the new GMP (2010 edition), the production pressure of pharmaceutical production enterprise has kept growing, thus the desire of the implementation of GMP management also becomes more urgent.The paper took a pharmaceutical production enterprise in Nantong City, Jiangsu province as an example. It analyzed the present situation of the enterprise and the problems and risks existing in the construction of GMP quality system, and put forward the corresponding improvement measures which can provide precious learning experience for other companies.Then, it expounded the key points of establishing quality system on the basis of the new GMP(2010 edition) and foreign GMP idea, including personnel, institutions, air conditioning system, water system, equipment, materials, Quality,file system and so on.Aspects of personnel, it described the details of organization construction of the manufacturing enterprise, the department, staffing, training and other aspects of detail management. Especially emphasized the training, this is the emphasis of GMP, the vast majority of the production management problems have relationship with training, so need to be training records management. For air conditioning systems, the details were described on the filter material management of air conditioning, air flow, etc. Water system mainly described the details of drinking water, purified water, water for injection, daily management details, etc. Equipment facilities mainly covered the equipment maintenance and management of production enterprises. Material aspects of the whole transfer process from the raw materials into the factory were covered. Quality department include QA and QC. The structure of file system was described in detail too.Based on the study of the construction of enterprise quality system, the basic framework of the quality system was established. Especially, in terms of the software system, many instances were provided. The entire file structure was also described in the form of attachment for the newly established API enterprises (non sterile) ease of reference, and it also can provide reference for enterprises with established quality system. The drug manufacturing enterprises can implement quality system on the basis of this quality framework, and the enterprises with GMP management system can also refer to it so as to perfect the GMP quality management system.This paper expounded the concept and development of GMP, form a clear impression. For building the GMP quality system’s each link, the items of disqualification were found and corresponding corrective measures are put forward, and then according to the measures for improvement. These items are focus of attention for the official or customer. Through the rectification of these questions, and then extended to all the details management, it is advantageous for the enterprise to improve the overall management level.