3rd Seminar for Pharmaceutical Rubber Plug Held in Hualan Biological Engineering LLC
The 3rd Seminar for Pharmaceutical Rubber Plug was held in wisdom source of Hualan Biological Engineering LLC from December 15, 2012 to December 16, 2012. People attending this Seminar including the drafting expert Wu Jun of GMP, Dunxin, a representative of pharmaceutical plant, the representative of rubber plug plant as well as the production, technology and quality personnel from plants in Jiangtyin and Fuling of Hualan Biological Engineering LLC.
On the seminar, Hua Guoping, the chairman of Hualan Shares firstly expressed gratitude to leaders and experts across the country participating in drafting up 3rd Seminar for Pharmaceutical Rubber Plug, and focused on introducing Wu Jun and Dun Xin, two draftsmen and experts of GMP as well as major participating leaders from Hualan Biological Engineering LLC. President Hua expressed this seminar was the 3rd session of preparation and discussion seminar for ‘Pharmaceutical Rubber Plug GMP’.
Afterward, Wu Jun and Dunxin, two experts discuss the norm design for rubber plug, three requirement including normative property, instructive nature and scientific characteristics as well as status analysis, etc of pharmaceutical stopper plug, and described the background of previous two seminars by which the norm is developed this time. Finally, Mater Wu difficult raised ten puzzling problems encountered in compiling the “Rubber Plug GMP”, and invited representatives from pharmaceutical manufacturers and rubber plug plants conducted discuss and gave advices regarding ten difficult problems on the seminar.
On the seminar with the duration of two days, representatives of Hualan Shares and other several rubber plug manufacturers expressed their viewpoints respectively on the formulation stability, surface cleanliness of rubber plug, environment, cleaning processes, plant purification level, batch division, declaration, approval and other issues. Representatives of West Pharmaceutical Services, Inc, a foreign counterpart also delivered their opinion on the change, registration and approval procedures for the rubber plug, product code issue and batch records.
When representatives of rubber plug manufacturers expressed their opinion, representatives of pharmaceutical plants also raised their views respectively, the representatives, without exception, thought that that the pharmaceutical manufacturer cares about three issues, namely the formulation stability, process stability and anti-mixed measures. Representatives raised requirements and opinions on repeated registration of products from manufacturers, change in the process, homogeneity of products, safety and other aspects of the rubber plug manufacturer.
On this seminar, representatives of experts, pharmaceutical manufacturers and rubber plug plants thoroughly expressed their own views, fierce collision of ideas merged in the course of the discussion, and the atmosphere was very hot on the site. Finally, Master Dun gave a summary of the seminar, Mr Dun expressed that more clearer positioning are conducted on the drafting of the rubber plug GMP through the discussion made by everyone present; learned more about the risk points which everyone cared; clearer objectives could be achieved on survey work at the next stage; the drafting work would make progress under the assistance of everyone; while he considered the rubber plug GMP to be a good tool to assist the pharmaceutical manufacturer reviewing the rubber plug plant
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