In order to further implement the newly revised drugs’ GMP, improve the quality control of the pharmaceutical manufacturers in Jiangsu Province and facilitate the sterile pharmaceutical manufactures to implement GMP for newly revised drugs, the Food and Drug Administration of Jiangsu Province held the Provincial GMP Initiative for Implementing Newly Revised Drugs and Training Course for Sterile Pharmaceutical Manufacturers in YRPG's Haiyan Hotel from May 22^ndto May 25^th.
The participants included the directors of the Food and Drug Administration, directors of Drug Safety Administration Departments of all cities, heads of Taizhou Pharmaceutical High-tech District Branch, legal representatives or general managers, quality responsible personnel or quality trustees of pharmaceutical manufacturers of all kinds of injections, sterile raw materials and eye drops. Ye Yaoyu, Deputy Director of the JFDA, Fan Luhong, Director, and Wang Dulan, Vice Director of the Drug Safety Administration Department, also attended the meeting, and took full part in the training.
During the initiative, JFDA required the sterile pharmaceutical manufacturers to implement as soon as possible the GMP for newly revised drugs, further understand the difficulties and problems that the manufacturers encounter during the implementation process of the GMP for newly revised drugs and arranged an introduction of the experience of part of the sterile pharmaceutical enterprises that have already passed the certification of new GMP for the newly revised drugs. Sha Qi, Production Manager of YRPG, also participated in the experience introduction.
On the subsequent training course the JFDA invited experts to give the participants training on such contents as cleaning validation and case analysis, environmental monitoring and case analysis, risk assessment and deviation management and case analysis, freeze drying machine and washing, filling and sealing linkage line equipment validation and technological innovation to solve problems encountered during the implementation of the new version of the GMP.
After the meetings and training courses, the enterprise representatives expressed gratitude to JFDA for this initiative and training courses. Given enterprises’ actual circumstances, they would accelerate the implementation of new GMP for the sterile pharmaceutical drugs, so as to make a positive contribution to build a strong pharmaceutical province of Jiangsu.