The Specific Project Inspection Team of National Food and Drug Administration for Rectifying and Sta
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Date:2013/8/1 0:00:00
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On January 17, a delegation of No. 6 summary and acceptance team for rectifying and standardizing the pharmaceutical market order arrived at YRPG at the leadership of Feng Shusheng, the food safety commissioner of National Food and Drug Administration to check and accept the pharmaceutical market order rectification affairs, with the accompany of Yu Shanjun, Director Assistant of the Municipal Food and Drug Administration, Sun Tianjiang, General Manager of the group and Liang Yuantai, General Manager Assistant.
Sun Tianjiang reported to the inspection team about the enterprise’s primary measures in its development of the self-rectification and inspection of the drug production to be primarily responsible for the drug quality. In recent years, YRPG has unceasingly strengthened the consciousness of the first responsible person for the drug quality by wide development of the quality consciousness education in the public, the examination and improvement in an overall and systematic manner. In the drug registration step, YRPG has received the onsite registration inspection by the national and provincial food and drug administration for five times in succession ever since September 2006 with the varieties under inspection up to 135. No variety was required to be withdrawn and the overall inspection result was recognized by the inspectors from the national and provincial food and drug administration. In the material purchase and testing step, the company has been persisting in controlling from the quality of raw and subsidiary materials with efforts made to strengthen the validity review of suppliers and establish an inner control standard under rigorous execution higher than the national statutory standard. In the production and quality step, the systematic examination has been carried out from multiple aspects including the satisfaction of the factory establishment and equipment, the feasibility and rationality of the prescription regulation and BPR as well as the suitability of the post SPO so as to implement the rectification earnestly. In the circulation step, specific people have been designated to carry out examination one by one according to the GSP, the Drug Operation License Administration Method and the Drug Retail Enterprise Specific Examination Form so as to avoid hidden troubles and establish a long-term management mechanism; at the same time, the consciousness of operation according to law has been reinforced with the strength of anti-commercial corruption intensified.
The delegation of the inspection team surveyed the high-rack warehouse, the quality testing center, No. 2 solid preparation workshop and the production base of Haici raw drugs to get a deeper understanding of YRPG’s practices of innovation depending on science and technology, strictly controlling the drug quality. Team leader Feng Shusheng highly recognized YRPG’s practices of increasing the consciousness of the first responsibility person and perfecting the quality control system from the origin. He believed that the enterprise had achieved prominent results in the specific project rectification, especially in terms of reinforcing the legal system and official clearance education which were featuring vivid characteristics. The enterprise had played the due role of a model of the leading enterprise of the pharmaceutical industry.
Responsible comrades from the Discipline Inspection and Supervision Department, the New Product R&D Department, the Production Quality Department and the Operation Office of the group attended the conversazione.