Continuous Quality Improvement Of The Whole Life Cycle Of Drugs In CZSY Company

With the implementation of China New GMP Guideline, China pharmaceutical companies are facing a more fierce competition, seeking a suitable quality management system is very important. Drug quality is not only involved into each manufacturing step, but also penetrates into the whole life cycle of a drug. Negligence in any section of life cycle of a drug may lead to the incompliance of quality. Therefore, continuous quality improvement is necessary in each process of the whole life cycle of a drug.The article describes some theories of quality management in the pharmaceutical industry. Meanwhile, necessity and feasibility of continuous improvement is discussed based on the problems that were found in the quality management system after making analysis to the current status of quality management of CZSY company. Based on the concepts of ISPE on Drug development (ICH Q8), Risk management (ICH Q9) and Pharmaceutical management system (ICH Q10), we make a program and establish a continuous quality improvement system through the whole life of a drug. Preliminary implementation conducted in CZSY company as a trial improved the current quality management system. Through making analysis to some typical cases, the article aims to demonstrate that continuous quality improvement in the whole life of a drug can improve the quality of the drug and enhance competitiveness of the company.