Organize on-site communication on the investigation of quality and safety hazards in drug production

On August 2nd, the Wenzhou Municipal Bureau organized 18 drug production enterprises in the city to hold regular production quality meetings and conducted on-site exchanges on the investigation of drug production quality and safety hazards. Xu Yiwei, Secretary of the Party Group of the Municipal Bureau, attended the meeting and conveyed the spirit of the provincial food and drug supervision symposium. He reviewed the registration and supervision work of the city's drug safety supervision in the first half of the year, assigned the main tasks for the second half of the year, and analyzed the investigation and summary of drug safety risks and hidden dangers.

In the first half of the year, the city's safety supervision registration work focused on the quality and safety of drug production, mainly carrying out centralized rectification in the field of drug production, effectively responding to incidents of chromium exceeding the standard, and conducting large-scale inspections of drug production quality and safety hazards; In the second half of the year, we need to focus on three key tasks: firstly, timely completion of rectification for identified risks and hidden dangers; Secondly, increase the implementation of the new version of GMP certification; Thirdly, in response to drug quality and safety, production enterprises should strengthen their awareness of quality and regulations, strictly implement GMP and drug standards, and effectively implement the requirements of the first responsible person in accordance with laws and regulations, especially Order No. 503 of the State Council.

Based on the six major types of hidden dangers identified during daily supervision and flight inspections in the first half of the year, various pharmaceutical production enterprises have conducted work exchanges in terms of audit of raw and auxiliary material suppliers, procurement inspection and warehousing of raw and auxiliary materials, execution of production process procedures, management of drug production and entrusted production, sample inspection of materials and finished products, and GMP implementation of drug production quality management. Zhejiang Kangle Pharmaceutical, Zhejiang Ruibang Pharmaceutical Representatives from Zhejiang Tianrui Pharmaceutical, Wenzhou Haihe Pharmaceutical, Zhejiang Cheng Yi Pharmaceutical, Zhejiang Haikang Biological and other companies gave speeches. The leaders and quality managers of 18 pharmaceutical production enterprises in the city, as well as the dispatched supervisors, attended the on-site exchange meeting.