Different reactions of pharmaceutical companies at the new GMP workshop

The new version of GMP is in the process of being revised, and many enterprises have heard of it The reporter interviewed some enterprise representatives on the spot and after the "seminar on improving the quality of drug production" Hao Ruixia, quality director of North China Pharmaceutical Group Beiyuan Co., Ltd.: this seminar was held very well, because quality management is the eternal theme of enterprise development The relevant leaders of the State Food and Drug Administration explained the highlights of the new GMP very clearly, and conveyed accurate and detailed information to the enterprise; meidan, director of Pharmacy Department of Union Medical College Hospital, gave a concrete and vivid speech, and put forward many very good suggestions and opinions to the production enterprise from the raw materials, auxiliary materials, packaging materials and even production process, which gave us a lot of good suggestions and opinions We can better understand the needs of front-line patients It is hoped that relevant associations and pharmaceutical associations can continue to give full play to the role of bridge, communicate and coordinate with government departments, transmit the voice of enterprises, and better promote the healthy development of the industry "Going out" is the only way for enterprises to grow and grow Therefore, we have been actively moving towards high standards and promoting the improvement of the level of preparations Since 2006, we have made GMP transformation and upgrading for some workshops in accordance with EU standards At the same time, we have invited foreign experts to train relevant employees We have one hope that the relevant departments should give policy support to the enterprises that have passed the new GMP certification in advance, so as to achieve high price, so as to improve the enthusiasm and initiative of enterprises in implementing the new GMP LV Juan, quality director of Shenyang Pharmaceutical Industry Co., Ltd.: we are an old enterprise Now there are more than a dozen preparation varieties in the state of production suspension due to the unfair competition of non-standard enterprises The enterprise is deeply troubled by the difficulties of development for quality and quantity At present, enterprises have been working hard in accordance with the requirements of the new GMP Last year, we did a re validation of injection process Before the re validation, relevant workshops and equipment have been transformed and replaced in accordance with EU standards This year, we are preparing to build a workshop for freeze-dried products At present, the drawings have come out, which are designed in full accordance with EU standards, and also refer to the relevant requirements of the new version of GMP expert opinion In terms of management, we use computer management system, and set up monitoring points at main production posts and key parts to ensure the standardized production of the enterprise; at the same time, we invite experts to train relevant personnel Last year, we invested several million yuan in software and hardware transformation This year, we invested more than 5 million yuan in new workshops (freeze-drying workshops) and small volume injection equipment Now, we pay close attention to the new version of GMP every day After the expert opinion is published, we immediately start to learn and strive to advance one step Luan yongzu, deputy general manager of Jinan Limin Pharmaceutical Co., Ltd.: at present, the national pharmaceutical policy is in the period of accelerating the pace of construction, and enterprises want to know how to do to keep up with the pace of national policy This seminar enables enterprises far away from the capital to listen closely to the voice of relevant departments of the state, which plays a role in preventing misinterpretation of policies and directly understanding the new developments of Zui We believe that the implementation of the new GMP is the general trend Since seeing the expert opinion draft, the company has organized internal personnel to study carefully and move closer to the new GMP in ideology At the same time, the company has made a serious self-examination - which areas need more investment and which areas need to focus on transformation At present, we have begun to implement the terms that we can achieve in the new GMP to prevent the document from being unprepared when it is actually published For example, the format and content of drug inspection records were improved, and workshop supervision was strengthened Ren Jun, chief engineer of Chaohu Jinchen Pharmaceutical Co., Ltd of Shanghai Haihong Industrial Group: I benefited a lot from attending the seminar on improving the quality of drug production