Focus on Pharmaceutical Quality-SunwayWorld was Invited to the 14th National Pharmaceutical Industry

2019-03-26 00:00:00

As a major manufacturing base of API in the world, the state drug watchdogs have revised many laws and regulations to guide pharmaceutical enterprises to operate in compliance, thus improving the quality and safety of drugs. As the traditional manual management can no longer meet the requirements, China Food and Drug Administration proposed the application of advanced information systems to enhance the quality management, aiming to enhance quality management of pharmaceutical enterprises.Good Manufacturing Practices for Pharmaceutical Product (Revision 2010) and its two appendices(No. 54 of 2015) as supporting documents, namely,Computer based System andConfirmation and Verification were issued by China Food and Drug Administration. At the same time, according to the Guidance on Promoting the Construction of Food and Drug Track-and-Trace System (draft for comments) jointly launched by seven ministries and commissions, including Ministry of Commerce, China Food and Drug Administration, "Drug production and trading enterprises shall carefully keep track of each procedure of drug production and trading, from material purchase, production, inspection, release, drug purchase, to drug acceptance, storage, maintenance, sales and storage. Keep complete and accurate records and use computer system for effective management."

To improve the quality control system of pharmaceutical enterprises, and help pharmaceutical enterprises improve product quality control, strengthen quality control and management, and well prepare for flight inspections, the 14th National Pharmaceutical Industry Quality Control Technology Forum (CPQC) was successfully held in 2019. More than 500 pharmaceutical representatives from all over the country gathered in Chengdu. As a professional provider of integrated solution of total quality management, SunwayWorld was invited to participate in the event.

Zhang Yongjian, Director, Research Center for Food and Drug Industry Development and Supervision, Chinese Academy of Social Sciences

At the meeting, Zhang Yongjian, director of the Research Center for Food and Drug Industry Development and Supervision of the Chinese Academy of Social Sciences, delivered an opening speech to the conference, briefing participants on the development of China's pharmaceutical industry, pharmaceutical quality supervision and other problems. Director Zhang also put forward practical and feasible suggestions according to the existing problems of pharmaceutical enterprises. The core recommendation is to increase the investment of pharmaceutical companies in pharmaceutical research and development sector, allowing the production process to gain better technical improvement and continuous upgrading. Efforts should be made to establish exchanges among government, industry, university and research institutes, so as to convert more scientific achievements into commercial success and sharpen the core competitiveness of each Chinese pharmaceutical enterprise. Most of the participants in this speech were senior front-line GMP inspectors and drafters of regulations in the pharmaceutical and drug control industry, who gathered together to share experience on management under new forms and technologies.

Zhang Jinping, Vice President of SunwayWorld, delivered a lecture on "How Informatized System Gives a Leg-up to the Compliance Management of Pharmaceutical Laboratories". At the meeting, General Manager Zhang gave a profound explanation on various items, from latest state regulations to their implementations. She mentioned that refined and intelligent management of information application has been realized, from the management of personnel, equipment and facilities, reagents, consumables, materials and other resources of pharmaceutical enterprises, to the quality control of the production process, regulation compliance, production environment monitoring, quality release and critical control process. In addition, the electronic signature, real-time tracking and whole-process audit of the application system have improved the management of active compliance of the enterprise, thereby avoiding many deviations or errors often occurred in the manual operation under the traditional manual management mode. Many pharmaceutical users who were impressed by advanced process control started to take photos to record.

Zhang Jinping, Vice President of Sunwayworld

Liao Binchi, the GMP inspector of the State Drug Administration, had in-depth discussions with the participants on "Document Records and Data Management of Drug Manufacturers”. Gong Yingjie, the GMP Inspector of the Market Supervision Administration of Deyang Municipality and State Drug Administration delivered a lecture on “Supervision and Inspection on Drug Manufacturers and FAQ'". Ren Ruilong, the GMP Inspector of Market Supervision Administration of Puyang Municipality and State Drug Administration delivered a lecture on “Qualified Person and Construction of Quality Management System". Liu Hua from the microbiology laboratory of Sichuan Food and Drug Inspection Institute shared a special report on "Applicability of Microbial Limit Test".

Liao Binchi, the GMP inspector of the State Drug Administration

As a professional integrated solution provider of testing and quality management, SunwayWorld stays committed to professionalism with more than twenty yearsexperience in drug manufacturing and testing. Seeing the facilitation of informatization of the pharmaceutical industry as its own responsibility, the company pursues technological innovation and professional personalized service, hoping to deliver sustainable value for customers. Going forward, SunwayWorld will work to provide integrated solutions of laboratory information management and quality management for more drug manufacturers and drug testing customers by sticking to national informatization development strategy.

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