Lixin Shi，Head of Production, Suzhong Group Pharmaceutical Limited

Topic: Challenge and Thinking on the Management of Traditional Chinese Medicine by Pharmacy Laws and Regulations

Speaker Bio

Lixin Shi, Bachelor degree of Pharmacy, Senior engineer, National licensed pharmacist, Party member of CPC. As head of production (production system party committee secretary) at  Suzhong  Group Pharmaceutical Limited. He has been working in pharmaceutical companies for 30 years, with full experienced in Production management, research management, quality management, enterprise management. Also, he has engaged in different pharmaceutical company as Plant manager, technical section chief, research Institute director, branch factory director, chief engineer, production vice-director, quality vice-director, GMP office director, production department manager，head of production etc. He has mainly responsible for the GMP authentication works like sterile preparation (non-terminal sterilization and terminal sterilization), tablet, capsule, granules, dry suspension, tincture, flow extracts, wine agent, distillate agent, mixture, oral solution, syrup agent etc. and all of them passed with a one-time GMP authentication.

He has published more than 30 science and technology articles on Pharmacist, Pharmacy, Medical Economics Newspaper and Mechatronics journals and finished new version GMP interpretation independently in Jan 2017. Lixin Shi was recruited Parma TEC Special writer by national journals Pharmacy. Currently, as the member of Jian Su Province Engineering Society.

Presentation Summary

Drug management regulations, various technical standards and quality standards are the legal basis for drug production, supply, use and management departments to follow, and is an important part of drug production quality management.

Since 1980s, China has introduced a series of regulations on drug administration from developed countries , which have played a very good role in drug administration. However, some laws and regulations of the individual provisions of are too obvious to mechanically copy, which are not suitable for the management of Traditional Chinese Medicine. 

The speaker follows the current laws and regulations and the Traditional Chinese Medicine Theory to explore reasonable solutions on the cultivation of medicinal materials, harvesting, processing of pieces, extraction and processing of Traditional Chinese Medicine, preparation production and other links, as well as the specific particularity of Traditional Chinese Medicine differences from chemical drugs.